04-230 Code Vt. R. 04-030-230-X - BOARD OF PHARMACY ADMINISTRATIVE RULES

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PART 1 GENERAL INFORMATION

Section 1.1. The Board's Purpose.

The Vermont Board of Pharmacy ("the Board") has been created and given powers by Vermont law, 26 V.S.A. Chapter 36. Its purpose is to protect the health, safety, and welfare of the public. The Board does this by, among other authority set forth in Chapter 36 and in Chapter 5 of Title 3, setting standards for examining and licensing qualified applicants, and regulating the practice of pharmacy.

Section 1.2. Board Restrictions.

The Board may not make any rule that is designed or implemented to limit the number of licensees or pharmacies in the state; nor may the Board require that nonprescription drugs be sold only by a pharmacist or under a pharmacist's supervision.

Section 1.3. Business Address.

The Board is located at the Office of the Secretary of State, Office of Professional Regulation, 89 Main St., Fl. 3, Montpelier, VT 05620-3402 ("the Office"). The Board's mailing address is the same. The Office telephone number is 1802-828-1505. Applications, copies of these rules, and additional information about the Board may be obtained by contacting the Office or by accessing the Board's website, http://vtprofessionals.org/.

Section 1.4. Board Members and Officers.

The Board is composed of five licensed pharmacists, each with at least five years' experience as a pharmacist in Vermont, and two members of the public. Public members of the Board shall have no financial interest in the field of Pharmacy, as defined in 26 V.S.A. § 2031 other than as consumers or possible consumers. Members of the Board are appointed by the governor as provided in 3 V.S.A. sections 129b and 2004. The Board elects a chair, a vice chair and a secretary, and other officers from among its members. A list of the names and addresses of Board members and officers may be obtained from the Office or the website.

Section 1.5. Hearings.

The Board conducts hearings in accordance with the Administrative Rules for the Office of Professional Regulation, 3 V.S.A. § 129, and the provisions of the Vermont Administrative Procedure Act for contested cases, 3 V.S.A. §§ 801 -816.

Section 1.6. Regular, Special, and Emergency Meetings.

The Board holds at least two regular meetings a year. The chair or a majority of members may call a special or emergency meeting. A majority of members constitute a quorum for all meetings. Contact the Office for the date, time and location of scheduled meetings.

Section 1.7. Laws that Govern the Board.

(a) The Board is governed by the law in 26 V.S.A. Chapter 36, that establishes its responsibilities for setting standards, issuing licenses, and regulating the profession. The Board is also governed by and exercises authority granted in Chapter 5 of Title 3 of the Vermont statutes. In addition, the Board must comply with several other statutes, such as the "Law of Professional Regulation," ( 3 V.S.A. §§121 - 132), the "Administrative Procedure Act" ( 3 V.S.A. §§ 801 -849), the "Right to Know Law" ( 1 V.S.A. §§ 311 - 314), and the "Access to Public Records Law" ( 1 V.S.A. §§ 315 -320). These laws establish rights for applicants, licensees, and the public. Please note that 3 V.S.A. § 129a also defines unprofessional conduct which can be the basis of disciplinary action.

(b) Most town clerks and libraries have copies of the Vermont Statutes Annotated, which contain the complete text of these laws. The Vermont Statutes Annotated may also be accessed through the Internet at http://www.leg.state.vt.us.

(c) The profession of pharmacy is governed by other state and federal laws among which are the Generic Drug Law; Food, Drug, and Cosmetic Acts; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); laws and regulations governing the use of alcohol; Federal Controlled Substance Act, 21 U.S.C. § 801 et seq.; Vermont Regulated Drug Act, 18 V.S.A. §§ 4201 - 42, and postal regulations to be followed when shipping legend drugs.

Section 1.8. Rules of the Board.

(a) The Board is authorized to make these Rules under 26 V.S.A. §2032. These Rules govern Board proceedings and have the effect of law. The Board reviews these rules periodically and revises them as needed. These rules may be cited as "BOP Rule x.x"

(b) Violation of these rules may result in disciplinary action by the Board or other federal or state authorities.

Section 1.9. Abbreviations Used in These Rules.

As used in these rules:

(a) ACPE: Accreditation Council for Pharmacy Education.

(b) DEA: Drug Enforcement Administration.

(e) FPGEC: Foreign Pharmacy Graduate Examination Committee.

(f) FPGEE: Foreign Pharmacy Graduate Equivalence Examination.

(g) MPJE: Multistate Pharmacy Jurisprudence Examination.

(h) NABP: National Association of Boards of Pharmacy.

(i) NAPLEX: North American Pharmacy Licensure Examination.

(j) OPR: Office of Professional Regulation, or "office."

(k) TOEFL: Test of English as a Foreign Language.

(l) TSE: Test of Spoken English.

(m) VAWD: Verified Accredited Wholesale Distributor.

Section 1.10. Definitions.

(a) As used in these rules:

(1) "Administer" or "Administration" means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means.

(2) "AMDS" means automated medication distribution system. An AMDS is an automated device or series of devices operated by an electronic interface with one or more computers that is used to prepare, package, or dispense specified dosage units of drugs for administration or dispensing to a patient or the ultimate user. "AMDS" includes a device that prepares and packages a drug for unit dose dispensing, that prepares and packages a drug into outpatient prescription vials, and that dispenses pre-packaged drugs.

(3) "Alternative evidence of the individual's identity" as referred to in 18 V.S.A. § 4215b means documents which reasonably permit a pharmacist to conclude that the individual is who he or she purports to be.

(4) "Bona fide representative of a patient" as referred to in 18 V.S.A. § 4215b means an individual who is authorized by law, or known to the patient and authorized by the patient to receive drugs dispensed by prescription for the patient.

(5) "Bona fide representative of an animal owner" as referred to in 18 V.S.A. § 4215b means the owner of an animal or a person authorized by the owner to receive drugs dispensed by prescription for the animal.

(6) "Beyond-Use Date" means a date determined by a pharmacist and placed on a prescription label at the time of dispensing that is intended to indicate to the patient or caregiver a time beyond which the contents of the prescription are not recommended to be used.

(7) "Board of Pharmacy" or "Board" means the Vermont Board of Pharmacy, or its designee.

(8) "Collaborative Pharmacy Practice" means that portion of pharmacy practice where a pharmacist may perform certain patient care functions under a protocol of specified conditions or limitations in collaboration with a practitioner. Collaborative practice agreements must be in writing and are valid for up to one year. After one year, a new written agreement is necessary for the collaboration to continue. Each collaborative practice agreement shall include provisions for no less than an annual quality assurance review by the collaborating practitioner. A pharmacist may have collaborative practice agreements with more than one practitioner.

(9) "Compounding" means the preparation of any active ingredients or added substances into a drug product

(A) as the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or;

(B) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer.

(10) "Confidential Information" means information accessed, maintained by, or transmitted to the pharmacist in the patient's records or which is communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or, as the patient directs, to those practitioners, other authorized health care professionals, and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well-being; and to such other persons or governmental agencies authorized or required by law to receive such confidential information, regardless of whether such information is in the form of paper, preserved on microfilm, or is stored on electronic media.

(11) "Deliver" or "Delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration.

(12) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, "Caution: Federal or State law requires dispensing by or on the order of a physician."

(13) "Dispense" or "Dispensing" means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.

(14) "Distribute" or "Distribution" means the delivery of a drug or device other than by administering or dispensing.

(15) "Drug" means:

(A) articles recognized as drugs in any official compendium, or supplement thereto, designated from time to time by the Board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;

(C) articles (other than food) intended to affect the structure or any function of the body of humans or other animals; and

(D) articles intended for use as a component of any articles specified in clause (A) (B) or (C) of this definition.

(16) "Drug regimen review and/or "drug utilization review" includes but is not limited to the following activities:

(A) Evaluation of the prescription drug order(s) and patient record(s) for:

(1) known allergies;

(2) rational therapy-contraindications;

(3) reasonable dose and route of Administration; and

(4) reasonable directions for use:

(B) Evaluation of the prescription drug order(s) and patient record(s) for duplication of therapy;

(1) drug-drug;

(2) drug-food;

(3) drug-disease; and

(4) adverse drug reactions.

(D) Evaluation of the Prescription Drug Order(s) and patient record(s) for proper utilization (including over or underutilization), and optimum therapeutic outcomes.

(17) "Electronic Transmission" means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment.

(18) "Electronic transmission intermediary" means an entity that provides the infrastructure that connects the computer systems or other electronic devices used by health care providers, prescribers, pharmacies, health care facilities, pharmacy benefit managers, health insurers, third party administrators, and agents and contractors of those persons in order to facilitate the secure transmission of an individual's prescription drug order, refill, authorization request, claim, payment, or other prescription drug information.

(19) "Electronic digital signature" means an electronic signature based upon cryptographic methods of originator authentication, and computed so that the identity of the signer and the integrity of the data can be verified.

(20) "Emergency Situations" for the purposes of authorizing an oral Prescription Drug Order of a Schedule II controlled substance, means those situations in which the prescribing practitioner determines (1) that immediate administration of the controlled substance is necessary for proper treatment of the patient, (2) that no appropriate alternative treatment is available, including administration of a drug which is not a Schedule II controlled substance, and (3) that it is not reasonably possible for the prescribing practitioner to provide a written prescription drug order to be presented to the person dispensing the substance, prior to the dispensing.

(21) "Equivalent Drug Product" means a drug product which has the same active ingredient(s), strength or concentration, dosage form, and route of administration and which is formulated to contain the same amount of active ingredient(s) in the same dosage form and to meet the same compendial or other applicable standards (i.e., strength, quality, purity, and identity), but which may differ in characteristics, such as shape, scoring, configuration, packaging, excipients (including colors, flavors, preservatives), and expiration time.

(22) "Fine/Civil/Administrative Penalty" is a monetary penalty permitted by law assessed against a licensee for violation of federal or state statutes or rules governing the practice of the profession.

(23) "Home Infusion Pharmacy" means a pharmacy which compounds solutions for direct administration to a patient in a private residence, long-term care facility, or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.

(24) "Labeling" means the process of preparing and affixing a label to any drug container exclusive, however, of the labeling by a manufacturer, packer, or distributor of a non-prescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or rule.

(25) "Legend drug" see definition of prescription drug below.

(26) "Long-Term Care Facility" means a nursing home, retirement care, mental care, or other facility or institution that provides extended health care to resident patients.

(27) "Manufacturer" means a person engaged in the manufacture of drugs or devices.

(28) "Manufacturing" means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.

(29) "Medical Order" means a lawful order of a practitioner that may or may not include a prescription drug order.

(30) "Medication Therapy Management" means a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication or a medical device.

(31) "Non-Prescription Drug" means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.

(32) "Office" means Office of Professional Regulation.

(33) "Patient Counseling" means the oral communication by the pharmacist of information, as defined in the rules of the applicable Board, to the patient or caregiver, in order to ensure proper use of drugs and devices.

(34) "Person" means an individual, corporation, subsidiary, partnership, association, organization, affiliate organization, or any other legal entity, including government.

(35) "Pharmacist Care" is the provision by a pharmacist of medication therapy management services, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process, as defined in the Rules of the Board.

(36) "Pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy.

(37) "Pharmacist-Manager" (also referred to as "Pharmacist in Charge") means a pharmacist currently licensed in this state who has held an unencumbered license in this or another state for at least two years, who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally in full and actual charge of such pharmacy and personnel.

(38) "Pharmacy" means any place within this state where drugs are dispensed and pharmaceutical care is provided and any place outside of this state where drugs are dispensed and pharmaceutical care is provided to residents of this state.

(39) "Pharmacy Intern" is a person working toward licensure as a pharmacist as set forth in Part 4 of these rules.

(40) "Pharmacy, Scope Of Practice." See, 26 V.S.A. § 2032(a)(1). Pharmacy is that profession which is concerned with the art and science of preparing, from natural and synthetic sources, suitable and convenient materials for distribution and use in the treatment and prevention of disease. It embraces a knowledge of the identification, selection, preparation, preservation, combination, analysis, standardization of pharmacologic action, and therapeutic use of drugs and medicines. As a health care profession, it also embraces the interpretation, evaluation, and dispensing of prescription drugs or drug orders in the patient's best interest; immunization; participation in drug and device selection, drug administration, drug regimen reviews and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for compounding and labeling of drugs and devices, proper and safe storage of drugs and devices and maintenance of proper records for them. It includes the management of drug therapy in collaboration with other health care providers responsible for patient care and the research, consultation, selection of drugs under protocol, and recommendation or provision of information necessary for drug therapy.

(41) "Practice of Telepharmacy" means the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance.

(A) "Practice of Telepharmacy Across State Lines" means the provision of pharmaceutical care through the use of telecommunications and information technologies that occurs when the patient is physically located within the jurisdiction and the pharmacist is located outside the jurisdiction.

(B) Those providing telepharmacy services must register with the Board and meet the requirements set forth in Rules 2.9 and 2.10.

(42) "Practitioner" means an individual currently licensed, registered, or otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.

(43) "Preceptor" means an individual who is currently licensed as a pharmacist by the Board of Pharmacy, who meets the qualifications as a preceptor under the rules of the Board, and participates in the instructional training of pharmacy interns.

(44) "Prescription Drug" or "Legend Drug" means a drug which is required under federal law to be labeled with either of the following statements prior to being dispensed or delivered:

(A) "Caution: Federal law prohibits dispensing without prescription;" or

(B) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian;" or

(C) a drug which is required by any applicable federal or state law or rule to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only.

(45) "Prescription Drug Order" means a lawful order from an authorized prescriber for a drug or device for a specific patient, including orders derived from collaborative pharmacy practice, that is communicated directly to a pharmacist in a licensed pharmacy. Non-verbal non-electronic prescriptions must bear the signature of the prescriber.

(46) "Tamper resistant prescription form" means a form meeting the requirements of Rule 9.5.

(47) "These Rules" mean the Administrative Rules of the Board of Pharmacy;

(48) "Primary Care" is the first level of contact of individuals, the family, and the community with the health care delivery system, bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process. (Areas of primary care where pharmacists provide pharmaceutical care include, but are not limited to, the following: chronic disease management; smoking cessation; maternal and child health; immunizations; family planning; self-care consulting; drug selection under protocol; treatment of common diseases and injuries; nutrition; and general health education and promotion.)

(49) "Repackage" means changing the container, wrapper, quantity, and labeling of a product or device to further the distribution of the drug or device.

(50) "Repackager" means one who repackages drugs or devices.

(51) "Signature" for purposes of a prescription, means an authorized prescriber's name handwritten by that person on a "hard" prescription, or that person's "electronic digital signature" as part of an electronic prescription sent directly to a pharmacy.

(52) "Significant Adverse Drug Reaction" means any drug-related incident that may result in serious harm, injury, or death to the patient.

(53) "Wholesale Distributor" means any person engaged in wholesale distribution of drugs, including but not limited to manufacturers, repackagers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses, independent wholesale drug traders, and retail pharmacies that conduct wholesale distributions.

Section 1.11. Acts Which May Affect Licensure, Registration, or Renewal.

The Board may discipline or deny licensure, registration, or renewal under these rules if any applicant, sole proprietor, partner, corporate officer, or owner has engaged in unprofessional conduct violating these rules, 3 V.S.A. § 129a, and 26 V.S.A. § 2051, or acts which directly affect the ability to practice pharmacy.

Section 1.12. Licenses, Registrations, and First Renewal.

An applicant issued an initial license or registration within 90 days of the renewal date will not be required to renew or pay the renewal fee. The license will be issued through the next full license period. An applicant issued an initial license more than 90 days prior to the renewal expiration date will be required to renew and pay the renewal fee.

Section 1.13. Renewals.

All licenses and registrations are renewed biennially on a schedule as determined by the office.

PART 2 REQUIREMENTS FOR PHARMACIST LICENSURE

Section 2.1. Routes to Licensure.

There are two routes to licensure as a pharmacist, licensure by examination and licensure by endorsement.

Section 2.2. Licensure by Examination, Qualifications for Licensure.

To be eligible for licensure as a pharmacist, an applicant must:

(a) Be at least 18 years of age;

(b) Submit an official transcript showing graduation from a pharmacy school approved by ACPE or other accrediting body approved by the Board;

(c) For foreign-trained applicants, have successfully passed the FPGEE, TOEFL, and TSE examinations or their successor examinations and hold an FPGEC certificate or its successor certificate demonstrating that their education was equivalent to the education at a school or college specified in subsection (b) above;

(d) Have completed an internship or demonstrated experience which is equivalent to an internship as set forth in Part 4 of these rules;

(e) Have passed the required examinations as set forth in Rule 2.3 below; and

(f) Have submitted an application form with photograph, and paid the appropriate fee.

Section 2.3. Examinations.

Licensure requires successful completion of the "NAPLEX" and the "MPJE." Contact NABP through its web site http://www.nabp.net/ for the date, time, and place of the examination.

Section 2.4. Required Examination Scores.

A minimum score of 75 must be attained on each component of the exam. An applicant who does not attain the required examination scores may elect to be re-examined. If the required score is not attained within one year, all previous scores shall be forfeited and the applicant must sit for and pass all components of the examination.

Section 2.5. Score Transfer.

Vermont will accept the NAPLEX score attained by an applicant from another state when the following requirements are met:

(a) The score is transferred through the NABP office under the conditions outlined by that Association;

(b) An application is submitted;

Section 2.6. Pre-Graduation Applications.

An applicant who has not yet graduated may submit an official transcript from his or her pharmacy school and arrange for certification of graduation to be sent to the Board under separate cover. Certification must be received by the Board before the applicant may sit for the examination.

Section 2.7. Licensure by Endorsement.

The Board may license an applicant who possesses an active license in a state whose current standards are substantially equivalent to the current standards in Vermont. The applicant shall submit:

(a) The Vermont application form and official NABP form, completed in full and signed by the applicant;

(b) Official verification of original licensure by examination;

(d) The prescribed application fee; and

(e) shall successfully complete the MPJE for Vermont.

Section 2.8. License Renewals.

Applicants for license renewal shall submit:

(a) The completed renewal form;

(b) A statement listing the continuing pharmacy education programs completed since the licensee's latest license was issued showing compliance with continuing education requirements;

(d) Any late fees or penalties required by law.

Section 2.9. Registration for Telepharmacy Across State Lines.

Pharmacy services may be provided via telepharmacy. A pharmacist providing telepharmacy services into the State of Vermont from another state is required to be registered as an "out of state registered pharmacist" with the Board. This registration requirement does not apply to pharmacists practicing in a non-resident licensed pharmacy.

(a) An applicant applying for registration to engage in the practice of telepharmacy across state lines shall:

(1) Present to the Board proof of licensure in another state and proof that such license is in good standing;

(2) Submit an application in the form prescribed by the Board;

(3) Pay the fee(s) specified by the Board for the issuance of the Registration; and

(4) Comply with all other requirements of the Board.

(b) The application required shall request of the applicant, at a minimum, the following information:

(1) Name, address, and current pharmacist licensure information in all other states, including state(s) of licensure and license number(s);

(2) Name, address, phone number, and, if applicable, state of licensure and license number of the site where the practice of telepharmacy will originate;

(3) A statement of the scope of patient services that will be provided;

(4) A description of the protocol or framework by which patient care will be provided;

(5) If applicable, any collaborative practice agreements with other health care practitioners; and

(6) A statement attesting that the applicant understands and will abide by the pharmacy laws and regulations of the State of Vermont.

(c) Registrations under this section shall be for the time period and follow the time schedule used for license and registration renewals.

Section 2.10. Telepharmacy Disclosure Requirements.

A pharmacist whose application for providing telepharmacy services across state lines has been approved shall:

(a) Identify himself or herself to patients as an "out of state registered pharmacist;"

(b) Notify patients of the jurisdiction in which he or she is currently licensed to practice pharmacy; and

Section 2.11. Inactive Status.

Subject to the reinstatement provisions of 26 V.S.A. § 2045, applicants for license renewal may request inactive status as permitted by law. A person who does not possess an active Vermont license may not practice pharmacy in Vermont.

Section 2.12. Reinstatement of an Inactive or Expired License.

(a) Once the expiration date on a license has passed, the license expires, and the license holder may not practice until reinstated. 26 V.S.A. §2045.

(b) To reinstate a license a holder of an inactive or expired license must comply with the continuing pharmacy education requirements set forth in these rules by accumulating a total of 30 hours for each renewal period during which the license was inactive. A person applying for renewal of an inactive or expired license shall not be assessed the renewal fees for the years during which the license was inactive or expired.

Section 2.13. Five Years Expired or Inactive Status.

(a) A pharmacist whose Vermont license has expired for 5 years or more, who is currently licensed in good standing in another US jurisdiction, must, before practicing independently,

(1) complete 60 hours of continuing education within four years preceding the application; and

(2) successfully complete the MPJE.

(b) A pharmacist whose Vermont license has expired for five years or more, and who has not been licensed in more than three years in another United States jurisdiction, must, before practicing independently,

(1) practice as an intern for no less than 200 hours under the direct supervision of a licensed pharmacist preceptor approved by the Board;

(2) complete 60 hours of continuing education within four years preceding the application; and

(3) successfully complete the MPJE.

PART 3 CONTINUING PHARMACY EDUCATION

Section 3.1. Definitions.

(a) ACPE: Accreditation Council for Pharmacy Education

(b) AMA: American Medical Association

(c) Live Programs (didactic sessions): Covers all programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences, and workshops.

Section 3.2. Continuing Pharmacy Education (CPE) Requirements.

The licensee must complete a total of 30 CPE hours per renewal period. A minimum of ten hours shall be obtained during participation in live programs (didactic sessions). Continuing pharmacy education participation must be reported every two-year renewal period. For newly-licensed pharmacists, see Rule 3.11 below.

Section 3.3. Limits.

CPE hours may not be transferred or carried over from one renewal period to another.

Section 3.4. Corrective Plan.

A licensee who fails to fulfill the continuing pharmacy education requirements of these rules may be required by the Board to develop and complete a specific corrective action plan within 90 days.

Section 3.5. Hardship Waiver.

Upon a showing a hardship, the Board may in its sole discretion waive the continuing pharmacy education requirement. To apply for a waiver, the licensee must submit a written statement setting forth the conditions of hardship with specificity. After review, the Board shall send written notification of its decision, and the reasons therefore, to the licensee.

Section 3.6. Out of State Licensees.

A licensee residing and licensed in another jurisdiction is required to meet the continuing pharmacy education requirements for license renewal in Vermont.

Section 3.7. Topics and Formats of Study.

Topics and formats of study shall include subject matter designed to maintain the professional competence of pharmacists licensed to practice and to improve their professional skills in order to protect the public health and safety.

Section 3.8. Documentation and Approval.

Providing documentation of continuing pharmacy education in Board-approved programs may be required to maintain licensure.

(a) All ACPE and AMA Category I approved programs and programs approved by pharmacy boards in other states may be approved by this Board.

(b) Organizations or licensees may have a program approved in advance by submitting the program outline, including learning objectives, and the names and qualifications of the presenters to the Board. After review, the Board shall send written notification of its decision to the organization or licensee.

Section 3.9. Verification of Continuing Pharmacy Education.

Pharmacists shall provide the Board with verification of completion of the required continuing pharmacy education programs by such means as designated by the Board. The Board may conduct random audits to verify completion of continuing pharmacy education up to four years after a license is renewed. Licensees must retain continuing education records to cover this period. Upon request by the Board, the licensee shall submit certificates of completion for all programs listed in the licensee's renewal application.

Section 3.10. Audits.

All reinstatements of inactive or expired licenses shall be audited and shall be accompanied by documentation of continuing pharmacy education. During each biennial renewal period, the Board may audit the continuing pharmacy education activities of a random sample of pharmacists. The Board may also audit currently conditioned licensees and licensees who in any of the preceding 3 renewal cycles were initially found to have not met continuing education renewal requirements. Pharmacists shall submit for inspection the documents necessary to verify the reported continuing pharmacy education.

Section 3.11. Newly Licensed Pharmacists.

(a) For applicants granted an initial license to practice by the Board, accumulation of CPE's shall commence on the opening date of the first biennial renewal period following receiving initial Vermont licensure.

(b) For those licensees granted an initial license within 90 days of the end of the licensing period/renewal date and who are not then required to renew their licenses, the continuing education requirement begins with the first day of the biennial licensing period so that all people licensed for two years at the time of their first renewal must show compliance with the continuing education requirements.

PART 4 PHARMACY INTERNS

Section 4.1. Definitions.

(a) Internship: means the practical pre-licensure experience where the intern is provided the knowledge and practical experience needed for licensure. The internship requirement may be fulfilled by postgraduate experience, supervised practice, and experience gained during participation in college-coordinated externship and clerkship programs.

(b) Supervised practice: means experience obtained during participation in Board-approved programs, as an intern under the direct supervision of a qualified preceptor as defined by these rules. The programs shall be designed to give the participant experience in the type of setting in which the preceptor practices.

(c) Externship: experience obtained during participation in college-supervised programs, under the supervision of a Board-approved preceptor. The programs must be conducted outside the classroom, in licensed pharmacies.

(d) Clinical Clerkship or Clerkship: means experience gained during participation in college-supervised programs which involve patient contact in either community or institutional settings. The programs must be designed with an emphasis on monitoring and evaluation of drug therapy. The clinical clerkship or clerkship must:

(1) Be conducted in patient care settings where the student is provided with actual experiences in patient care;

(2) Emphasize all phases of drug therapy relative to the disease states of individual patients;

(3) Involve provision of clinical services on either an outpatient or inpatient basis as a primary activity;

(4) Involve a minimal amount of drug distribution;

(5) Be approved by the state board of pharmacy where the pharmacy school is located; and

(6) Be a component of the college curriculum for which academic credit is given.

(e) Preceptor: means a pharmacist with an active license, who has at least 2,000 hours experience in the actual practice of pharmacy, approved by the Board of Pharmacy in his or her state of licensure to supervise and direct the training of a pharmacy intern. To be a preceptor in Vermont the licensee must possess an unencumbered license. The Board at its discretion upon good cause may permit a licensee with a conditioned license to act as a preceptor.

Section 4.2. Registration of Pharmacy Interns.

(a) Every individual shall be registered with the Board before beginning an internship in this State.

(b) Prior to beginning any period of internship in Vermont, a prospective intern shall submit, on official forms, the following information:

(1) The intern's name and address;

(2) The name and address of the pharmacy where the internship is being served;

(3) The name, address, and license number of each preceptor at the internship site; and

(4) A complete statement of the intern's qualifications, to be provided directly to the Board by the pharmacy school or college.

(c) Forms required for proper registration of interns, along with instructions for their use, are available from the Board.

Section 4.3. Pharmacy Intern Qualifications.

Registration to practice pharmacy as an intern shall be granted only to:

(a) an individual who is currently enrolled the first professional year in an accredited pharmacy program; or

(b) a graduate of an ACPE accredited pharmacy program; or

(c) a graduate of a pharmacy program located outside the United States who has successfully completed the FPGEE, TOEFL, and TSE examinations or their successor examinations, and obtained Foreign Pharmacy Graduate Examination Committee (FPGEC) certification.

Section 4.4. Internship Non-Classroom Hours.

At least 500 hours of internship experience must be outside the classroom in a setting in which the intern provides direct patient care services, as an intern under the direct supervision of a pharmacist. Documentation shall be provided on a form available from the Board.

Section 4.5. Internship Expected Experience.

Experience obtained in hospital or retail settings should include compounding, dispensing, inventorying prescription drugs, and maintaining prescription records.

Section 4.6. Internship Other Possible Experiences.

With approval of the Board, the internship may also include experience obtained in one of the following:

(a) A demonstration project related to pharmacy;

(b) The pharmaceutical industry; or

Section 4.7. Internship Training and Practice Site Requirements.

The pharmacy at which an intern is being trained shall provide an environment that is conducive to the learning of the practice of pharmacy by an intern. The pharmacy must:

(a) Conform to all standards set by governmental agencies;

(b) Provide a broad scope of pharmaceutical services;

(d) Use a patient medication record system;

(e) Provide the opportunity for chart review in a practice setting in which charts are used;

(f) Maintain contact with other health professionals and, when possible, provide pharmaceutical services to institutionalized patients; and

(g) Provide patient counseling services.

Section 4.8. Exposure to Practice Areas.

It is expected that the intern will be exposed to all facets of the practice of pharmacy, including but not limited to, the following:

(a) Evaluation of prescription drug orders;

(b) Preparation and labeling of drugs;

(d) Patient profile update and review;

(e) Drug use review;

(f) Patient counseling; and

(g) Proper and safe storage of drugs.

Section 4.9. Other Conditions Governing Internships.

Interns enrolled in a pharmacy school approved by ACPE may participate in cooperative plans or other suitable arrangements developed by the pharmacy school and approved by the Board. Internship programs in non-traditional practice sites (e.g., industry-sponsored programs) must be approved by the Board prior to granting of internship credit.

Section 4.10. Armed Forces Members.

Members of the armed forces who served under conditions fulfilling internship requirements may submit documentation for approval by the Board. Participation in activities equaling or exceeding Vermont internship requirements shall be recognized on an hour-for-hour basis.

Section 4.11. Out of State Credit.

The Board will give credit for out-of-state or Canadian internship experience upon presentation of an affidavit or certificate of approval indicating the internship was approved in the state or province where the experience was obtained. The intern shall abide by all the provisions of the internship rules in that state or province and shall provide evidence from that state's or province's board of pharmacy of the number of clock-hours of experience actually participated in by the intern. Documentation may be provided on a form available from the Board.

Section 4.12. Responsibilities of Intern.

The intern may perform only those duties assigned by the pharmacist.

Section 4.13. Internship: No Supervisory Duties.

The intern shall not be in charge of the pharmacy department at any time.

Section 4.14. Pharmacy Interns Identified.

(a) The Board shall issue a confirmation letter or registration certificate to the intern for purposes of identification and verification of his or her role as an intern.

(b) A pharmacy intern shall wear a name tag bearing in a clearly legible font the individual's name and title "Pharmacy Intern."

(c) An individual who is not properly registered with the Board as an intern shall not take, use, or exhibit the title of intern, or any other similar term.

Section 4.15. Change of Information.

All interns shall notify the Board immediately upon change of name or address.

Section 4.16. 1,740 Internship Hours Required.

Applicants for licensure as pharmacists shall submit evidence on Board-approved forms that they have satisfactorily completed no fewer than 1,740 hours of internship credit under the instruction and supervision of a preceptor.

Section 4.17. End of Registration.

Without Board approval on a showing of extenuating circumstances Registration ends upon:

a) dismissal from pharmacy school, or

b) one year after graduation or until licensed, whichever occurs first.

Section 4.18. Board Jurisdiction over Interns.

Interns are subject to the disciplinary authority of the Board. Interns must report a conviction of any felony or any offense related to the practice of the profession in a Vermont district court, a Vermont superior court, a federal court, or a court outside Vermont within 30 days.

Section 4.19. Preceptor, Primary Responsibility.

The preceptor shall have the primary responsibility for the training of the intern. This includes ensuring that the pharmacy intern is registered with the Board.

Section 4.20. Preceptor Duties.

(a) The preceptor may allow other pharmacists to aid in the training process.

(b) The preceptor may permit an intern to provide services normally provided by a pharmacist provided that the services performed are under the direct supervision of a pharmacist.

(c) A pharmacist shall be in continuous personal contact with and actually give instructions to the intern during all professional activities throughout the entire internship period. The pharmacist shall physically review the prescription drug order and the dispensed product before the product is delivered to the patient or the patient's agent. The pharmacist is responsible for the work of the intern.

Section 4.21. Preceptor Intern Information Required.

The preceptor shall submit, on approved forms, such information as the Board requires.

Section 4.22. Preceptor Limitation.

A pharmacist may not act as a preceptor of more than two interns working at a pharmacy at any one time.

PART 5 PHARMACY TECHNICIANS

Section 5.1. Definition of Pharmacy Technician.

A pharmacy technician is "an individual who performs tasks relative to dispensing and only while assisting and under the supervision and control of a licensed pharmacist." 26 V.S.A. § 2022(13).

(a) Effective July 1, 2017: These rules create two categories of pharmacy technicians, "certifies pharmacy technicians" and pharmacy technicians who are not certified. The latter group are referred to as "pharmacy technicians."

(b) Cashiers, and delivery people who enter or have access to the prescription department must register as pharmacy technicians.

Section 5.2. Certified Pharmacy Technician.

Certified pharmacy technician means personnel registered with the Board who have completed a pharmacy technician certification program approved by the Board.

(a) Effective July 1, 2017 each individual performing the acts in subsection (b) below must be registered with the Board as a "certified pharmacy technician."

(b) A certified pharmacy technician may, under the supervision of a Pharmacist, perform certain activities involved in the Practice of Pharmacy, such as:

(1) receiving new written or electronic Prescription Drug Orders, prescription data entry;

(2) compounding;

(3) assisting in the dispensing process; and

(4) performing all functions allowed to be performed by pharmacy technicians.

(1) drug utilization review (DUR);

(2) clinical conflict resolution;

(3) receipt of new oral prescription drug orders

(4) prescriber contact concerning prescription drug order clarification or therapy modification;

(5) patient counseling;

(6) prescription transfer;

(7) dispensing process validation; or

(8) any act requiring the exercise of professional judgment by a pharmacist.

Section 5.3. Certified Pharmacy Technician Registration.

(a) To be registered as a certified pharmacy technician, an applicant shall:

(1) submit a completed application showing that the applicant is certified by a national pharmacy technician certification authority approved by the Board;

(2) pay the fee specified in statute;

(3) not have engaged in acts which affect the ability of the applicant to practice as a pharmacy technician;

(4) have attained the age of 18 years and be a high school graduate or equivalent.

(b) An individual who has held a pharmacist license that has been revoked or suspended for unprofessional conduct, or whose application for licensure as a pharmacist has been denied for unprofessional conduct, shall not be eligible to be registered as a certified pharmacy technician unless the Board, in its sole discretion, determines that good cause exists to register than individual.

(c) A certified pharmacy technician while working in the prescription department shall wear a name tag bearing in a clearly legible font, at a minimum, the individual's first name and title "Certified Pharmacy Technician."

(d) A person whose application for registration has not been approved may not act as a certified pharmacy technician.

Section 5.4. Maintaining Certification.

An individual registered with the Board as a certified pharmacy technician must maintain national certification. A person whose national certification has lapsed or has in any other way not met the requirements for continued national certification shall not practice as a registered certified pharmacy technician.

Section 5.5. Pharmacy Technician.

Pharmacy Technician means an individual registered with the Board as a pharmacy technician.

(a) A pharmacy technician may, under the supervision of the pharmacist, assist in the pharmacy and perform such functions as:

(1) receiving requests for refills of current prescriptions;

(2) processing of medical coverage claims;

(3) inventory responsibilities; and

(4) cashiering.

(b) A pharmacy technician may not perform such functions as:

(1) assisting in the dispensing work flow;

(2) drug utilization review (DUR);

(3) clinical conflict resolution;

(4) prescriber contact concerning prescription drug order clarification or therapy modification;

(5) patient counseling;

(6) prescription transfer;

(7) receipt of new prescription drug orders; or

(8) any act requiring the exercise of professional judgment by a pharmacist.

(c) A pharmacy technician in training to become a certified pharmacy technician may, after registering with the Board, under the direct supervision of a pharmacist, engage in certified pharmacy technician acts for up to 18 months. A pharmacy technician who has not successfully completed the requirements to become a registered certified pharmacy technician in 18 months may apply to the board for an extension. The Board shall, in its sole discretion, determine whether such an extension is appropriate.

Section 5.6. Pharmacy Technician Registration.

(a) To be registered as a pharmacy technician, an applicant shall:

(1) submit a completed application;

(2) not have engaged in acts which affect the ability of the applicant to practice as a pharmacy technician.

(c) A pharmacy technician while working in the prescription department shall wear a name tag bearing in a clearly legible font, at a minimum, the individual's first name and title "Pharmacy Technician."

(d) A person whose application for registration has not been approved may not act as a pharmacy technician.

Section 5.7. Renewals.

Certified pharmacy technician registrations and pharmacy technician registrations shall be renewed biennially on a schedule as determined by the Office.

Section 5.8. Jurisdiction.

Certified pharmacy technicians and pharmacy technicians are subject to the disciplinary authority of the Board.

Section 5.9. Transitional Provision Grandfather Clause.

Effective July 1, 2017. A person who has not completed a national pharmacy technician program approved by the Board may be registered as a Vermont certified pharmacy technician if:

a) As of July 1, 2017 the person has been a Vermont registered pharmacy technician in good standing with an unencumbered registration continuously since July 1, 2014;

b) The person currently engages in the tasks reserved for certified pharmacy technicians under Rule 5.2(b);

c) The person pays the applicable fee and submits an application for transition from a Vermont Registered Pharmacy Technician to a Vermont Certified Pharmacy Technician which application shall include a verification by oath or affirmation containing:

1. a detailed description of the certified pharmacy technician tasks set forth in these rules and that the applicant has engaged in, signed by both the applicant and the pharmacist-manager or supervising pharmacist; and

2. verification by the pharmacist manager or supervising pharmacist that the applicant/pharmacy technician currently performs those certified pharmacy technician tasks competently to the satisfaction of the pharmacy manager or supervising pharmacist, and a statement by the pharmacist-manager or supervising pharmacist that the applicant/pharmacy technician is qualified to serve as a certified pharmacy technician in that pharmacy practice location.

d) A person registered as a Vermont certified pharmacy technician under this Rule is not as a condition of renewal required to obtain or maintain certification from a national certification program approved by the Board.

e) An individual who becomes a Vermont certified pharmacy technician under this Rule may continue to practice as a certified pharmacy technician only in that person's current practice pharmacy location and employer. Registration with the Board as a Vermont certified pharmacy technician under this rule will terminate with the cessation of practice at the registrant's current practice location. To be hired to practice at any other pharmacy location will require that the individual obtain and maintain certification from a national certification program approved by the Board.

f) A person registered as a Vermont Certified Pharmacy technician under this rule must notify the Board within 10 days of terminating employment at his or her current location.

g) Registration as a certified pharmacy technician under this rule is available between July 1, 2017 and July 1, 2018. The Board will permit applications to be submitted in March of 2017 in hopes that successful candidates will be able to receive their certified pharmacy technician registrations and be ready to practice under them on July 1, 2017. Unsuccessful applicants will be advised of the appeal process.

h) The intent of this grandfather clause is to ensure that after July 1, 2017 all newly hired certified pharmacy technicians in Vermont are certified by a national certification program approved by the Board.

PART 6 PHARMACIST-MANAGER

Section 6.1. Pharmacist-Manager Required.

No pharmacy may operate unless its designated pharmacist-manager has been approved by the Board.

Section 6.2. General Duties and Limitations.

The pharmacist-manager shall be responsible for the direct management, supervision, and control of the pharmacy department.

(a) After the effective date of these rules, to serve as a pharmacist manager a pharmacist shall have been licensed and in good standing as a pharmacist in this state or in another state with substantially similar requirements for licensure for at least two years. Unless granted written permission by the Board, a licensee is required to possess an unencumbered license while serving as a pharmacist-manager.

(b) A pharmacist may not serve as pharmacist-manager unless he or she is physically present in the pharmacy a sufficient amount of time (30% of the hours the prescription department is open or at least 40 hours per week, whichever is less), to provide supervision and control.

(c) A pharmacist may not serve as pharmacist-manager for more than one pharmacy at any one time except as specifically allowed by written permission from the Board.

Section 6.3. Duties Included.

The pharmacist-manager shall:

(a) be responsible for proper closing of the drug outlet; or if a foreclosure or bankruptcy, the official in charge shall obtain the services of a pharmacist to serve as acting pharmacy-manager.

(b) be responsible for required record keeping of drugs and devices that are destroyed, surrendered to the Board, or returned to the wholesaler or manufacturer for disposal.

(d) ensure that all policies and procedures are in computerized form or if written shall be collected in a format such as a three-ring binder that can be easily accessed, updated and revised as necessary.

(e) assure that the automated pharmacy dispensing system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards.

(f) implement an ongoing quality assurance program that monitors performance of the automated pharmacy dispensing system, which is evidenced by written policies and procedures adopted by the pharmacy.

(g) assure that all pharmacists employed at the pharmacy are properly licensed, all pharmacy technicians are properly registered and Health Insurance Portability and Accountability Act (HIPAA) trained, and that all pharmacy interns employed at the pharmacy are properly registered with the Board of Pharmacy.

(h) report to the Board within 10 days, along with supporting information and evidence, any disciplinary action taken by it or its staff, after an initial investigation, or hearing in which a pharmacist, pharmacist intern, or pharmacy technician has been afforded the opportunity to participate, which limits or suspends, conditions, or terminates that person's employment for drug diversion or violations of the rules and statutes governing pharmacy practice. If the pharmacy manager is disciplined, the pharmacy owner shall report the action to the board. See, 3 V.S.A. § 128.

(i) Notify the Board of Pharmacy immediately of any of the following changes on forms provided by the Board:

(1) Any theft or significant loss of prescription drugs shall be reported to the Board immediately by telephone, email or fax. Within three days, a written report shall be made on forms available from the Board and on line for this purpose;

(2) Change of ownership of the pharmacy, including the filing of a new application for licensure by the owner, corporate officer of partner;

(3) Change of address of the pharmacy, or if change of location, including the filing of a new application;

(4) In the event of bankruptcy or foreclosure, the official in charge shall obtain the services of a pharmacist to serve as acting pharmacist-manager;

(5) Permanent closing of the pharmacy; and

(6) Disasters, accidents and emergencies which may affect the strength, purity or labeling of drugs, medications, devices or other materials used in the diagnosis or the treatment of injury, illness and disease shall be immediately reported to the Board;

(j) Make or file any reports required by state or federal laws and rules;

(k) Respond to the Board of Pharmacy regarding any violations brought to his or her attention;

(l) Establish policies and procedures for maintaining the integrity and confidentiality of prescription information and patient health care information, or verifying the existence thereof and ensuring that all employees of the pharmacy read, sign, and comply with the established policies and procedures;

(m) Provide the Board with prior written notice of the installation or removal of automated pharmacy systems. The notice must include, but is not limited to:

(1) The name and address of the pharmacy;

(2) The name and location of the automated equipment; and

(3) The identification of the responsible pharmacist.

Section 6.4. Pharmacy Technicians, When Required.

The pharmacist-manager shall be assisted by a sufficient number of pharmacists and pharmacy technicians as may be required to competently and safely provide pharmacy services.

Section 6.5. Pharmacy Technician Training Manual.

The pharmacist-manager shall develop or adopt, implement, and maintain a pharmacy technician training manual for that pharmacy. The training manuals of the National Community Pharmacists' Association (NCPA) and National Association of Chain Drug Stores (NACDS), or others as approved by the Board may be used as guides.

Section 6.6. Implementing a Procedure for Drug Recalls.

The pharmacist-manager shall develop and implement a written procedure for proper management of drug recalls which may include, where appropriate, contacting patients to whom the recalled drug product(s) have been dispensed.

Section 6.7. Change of Pharmacist-Manager.

When a pharmacist-manager changes employment or responsibilities, he or she shall do the following:

(a) Within 5 days, the outgoing and incoming pharmacist-managers shall notify the Board, in writing, regarding his or her change in employment.

(b) The outgoing pharmacist-manager shall conduct a physical written inventory of all controlled drugs, explain any discrepancies in full, certify the inventory as true and correct, and retain a copy for his or her records.

(c) The inventory shall be certified as true and correct, by the incoming pharmacist-manager, and filed with the permanent records of the drug outlet.

(d) The inventory shall be signed by both the incoming and outgoing pharmacist-managers, and a copy submitted to the Board as an attachment to the forms provided.

(e) A new license, indicating the name of the new pharmacist-manager will be issued upon approval.

PART 7 RULES FOR OPERATION OF DRUG OUTLETS

Section 7.1. Forms of Ownership.

Retail drug outlets may be owned by a sole proprietor, partnership, corporation or professional corporation.

Shareholders of a professional corporation shall be considered individual pharmacists for disciplinary purposes.

Section 7.2. Application and Procedure for Opening a Retail Drug Outlet.

Applicants shall use the standard form available from the Office or via the website. Completed applications shall include:

(a) The Office application form, completed in full and signed by an owner, corporate officer or partner;

(b) A scale drawing of the outlet, indicating space utilization and security arrangements in detail, and showing in detail the patient counseling area, attached to the application;

(d) A list of all stockholders of a parent corporation owning five percent or more of the corporation's assets;

(e) Affirmation by the sole proprietor, or all partners, or corporate officers and directors, and the pharmacist-manager, that they have not been convicted of, and are not under indictment for, any felony or misdemeanor arising from the violation of any drug or pharmacy related law; and,

(f) If the applicant is a corporation:

(1) A copy of the corporate charter; and

(2) If non-publicly traded, a list of all stockholders owning five percent or more of the corporation's assets.

(g) The approximate date of completion, if a new drug outlet.

Section 7.3. Inspection before Licensure.

(a) A Board representative shall make an on-site inspection within 20 days of a request for inspection. The pharmacist-manager must be present for this inspection.

(b) If deficiencies are found:

(1) The Board representative shall send written notification to the applicant and the Board, noting all unremedied deficiencies.

(2) If the Board receives evidence of correction of the deficiencies, or upon order of the Board, an on-site inspection shall be made by a Board representative within 30 days. If an unremedied deficiency remains after a re-inspection, the procedures outlined in this rule shall apply. A denial of licensure based on an unsatisfactory inspection may be appealed as provided by 3 V.S.A. § 129(e).

Section 7.4. Successful Inspection, License Issued, Time of Opening.

(a) If there are no deficiencies, or deficiencies noted above have been corrected, a license shall be issued.

(b) The pharmacy may not open until it has provided the Board:

(1) confirmation of the its DEA license; and

(2) confirmation of an adequate supply of drugs.

Section 7.5. Pharmacist-Manager Required.

No pharmacy shall be operated without a designated pharmacist-manager approved by the Board. The pharmacistmanager of a pharmacy shall be designated in the application of the pharmacy for license, and in each renewal thereof. Requirements for pharmacist-managers and their responsibilities are set forth in Part 6 of these rules. Additional pharmacist-manager duties are specified elsewhere in these rules.

Section 7.6. Opening Date Notice Required.

The applicant shall give at least 10 days' notice to the Board prior to opening for public business.

Section 7.7. Changes in Corporation.

A non-publicly traded corporation shall immediately notify the Office, in writing, of any changes in officers, or stockholders owning five percent or more of the corporation.

Section 7.8. Change or Transfer of Ownership.

Business may continue uninterrupted when ownership of the retail drug outlet is changed or transferred to an individual or entity required to be listed as an owner in an application for initial licensure if the new owner:

(a) Notifies the Board within 48 hours after the transfer;

(b) Submits a completed application within 15 business days after the transfer;

(d) States the date of transfer on the application.

Section 7.9. Change of Mailing Address or Location.

(a) The licensee shall submit immediate written notification of any change in mailing address of a drug outlet.

(b) A licensee shall notify the Board within 48 hours after changing the location of a drug outlet, and shall not open for business in the new location until after successful completion of an inspection.

(c) In order to continue business without interruption, the licensee shall, at least 60 days prior to a change in location of a drug outlet, submit an application for a new license. All equipment and library materials approved for use in the new location must be transferred prior to opening for public business.

Section 7.10. Renovations.

Before reopening for business after remodeling or relocation which affects the security of a pharmacy, the drug outlet must successfully complete an inspection. In order to continue business, the licensee shall notify the Board 60 days prior to the changes, submitting a scale drawing of the outlet, indicating space utilization and security arrangements in detail. The pharmacist-manager shall notify the Board in writing when renovations are completed.

Section 7.11. Natural Disaster, Fire, or Other Catastrophe.

(a) Upon written request after a natural disaster or fire, the Board may issue an immediate 60 day emergency license for operation of the drug outlet at a new location.

(b) A Board representative shall conduct an on-site inspection at the proposed location. The Board shall issue the emergency license if security conditions are satisfactory.

(c) No equipment, supplies, or drug inventory from the old location shall be used in the new location without Board approval.

(d) Upon application, prior to the expiration of the emergency license, the Board may continue the emergency license up to a period of two years from the original date of the emergency license.

Section 7.12. Death of Owner.

(a) Following death of a sole proprietor or partner, the Board may issue a temporary license only if the legally appointed representative of the decedent's estate has named a licensed pharmacist-manager to operate the drug outlet.

(b) The temporary license shall be effective until:

(1) The drug outlet has been properly reorganized; or

(2) Ownership has been transferred; or

(3) The drug outlet has been closed; or

(4) One year has elapsed since death of the owner.

PART 8 DRUG OUTLET CLOSURE

Section 8.1. Voluntary Surrender of Drug Outlet License.

The Board may accept a license to operate a drug outlet that has been surrendered voluntarily, if:

(a) The licensee submits, in writing, a signed statement setting forth the reasons the license is being surrendered; and

(b) All prescription legend drugs are properly disposed of under these rules; and

Section 8.2. Termination of License to Operate a Drug Outlet.

Unless a temporary license has been applied for within 5 business days of the following, a license to operate a drug outlet is immediately terminated:

(a) If a sole proprietorship: death of owner, change of location, change in ownership, or change in business name.

(b) If a partnership: death of a partner, change of location, change in partners or other change in ownership, change in business name, or other factors as provided in statutes governing partnerships.

(d) Failure to register a change in pharmacist-manager.

Section 8.3. Drug Outlet Closing.

If the closing of a drug outlet is not planned, the licensee shall notify the Board of the closing within 48 hours. The licensee shall notify the general public of the intent of the licensee and the future location of prescription files by advertising in a newspaper with a general circulation in the area served, and by posting signs in a conspicuous place at or near the drug outlet.

(a) The licensee shall arrange for a responsible agent to maintain all prescription drug outlet records for three years from the date the outlet is closed.

(b) If the closing of a drug outlet is planned, the licensee shall, at least 15 days prior to the closing, send the Board written notification of the following:

(1) The date the outlet will close for public business;

(2) The name(s) and address(es) of the person(s) with custody of prescription, bulk compounding, repackaging, and controlled drug inventory records;

(3) The names and addresses of all persons who will acquire legend drugs when the drug outlet closes.

(1) The licensee voluntarily surrendered the license to operate a drug outlet;

(2) All legend drugs were transferred to another authorized drug outlet, or returned to wholesalers or manufacturers, or destroyed, and the name(s) and address(es) of the drug outlet(s) receiving the legend drugs;

(3) All labels and blank prescription pads were destroyed;

(4) All signs indicating the presence of a drug outlet were removed; and

(5) Confirmation that the DEA registration and all unused DEA 222 forms were returned to the DEA.

(d) The licensee shall, at least 30 business days in advance, notify the general public of the date of closing and the future location of prescription files, in the following manner:

(1) Advertise in a newspaper with a general circulation in the area served; and

(2) Post signs in a conspicuous place in the drug outlet.

PART 9 STANDARDS FOR PHARMACIES

Section 9.1. Facility.

Minimum requirements for a pharmacy:

(a) No pharmacy may operate without a designated pharmacist-manager.

(b) Each dispensing pharmacy shall be of sufficient size (minimum of 200 square feet) to allow for the safe and proper storage of prescription drugs and for the safe and proper compounding and preparation of prescription drug orders.

(c) If the store is open at times when the prescription department is closed, the prescription area must be permanently enclosed by a partition or Board-approved barrier device at least nine feet six inches in height, except where the ceiling is less than nine feet six inches, in which case the partition or Board-approved barrier device shall be from floor to ceiling.

(d) The prescription department must contain no less than 12 feet of counter space two feet in width. If two or more pharmacists are on duty at the same time, the counter shall be four feet longer for each additional pharmacist. The prescription counter shall be kept free of any items not being used in the practice of pharmacy. No television monitors shall be located in the prescription department, and no such equipment shall be placed to as to distract the pharmacist from the practice of pharmacy. The aisle space behind the prescription counter shall be wide enough to allow free movement and shall be kept free of obstructions. The prescription department shall have a sink of appropriate size, exclusive of drain board area, necessary to fulfill the needs of the pharmacy. The sink shall be connected to hot and cold running water, shall have a working drain, and shall be convenient to the compounding area for the purpose of hand scrubs prior to compounding.

(e) Each pharmacy shall provide internet access as needed for compliance with the prescription monitoring system.

Section 9.2. Counseling Area Required.

Each pharmacy providing outpatient prescriptions directly to the public or employees, shall maintain an area designated for the provision of patient counseling services. This area shall be designed to provide reasonable privacy.

Section 9.3. 24 Hour Access.

The pharmacist-manager, or a pharmacist designated by him or her, shall have 24 hours access to the pharmacy department.

Section 9.4. Signs and Names.

(a) The only name(s) used to identify the drug outlet at the site or in advertisements shall be the name(s) registered with the Board.

(b) The drug outlet shall display pharmacy business hours and the name of the pharmacist on duty in a conspicuous manner visible to the public.

(c) Use of words "drugs," "medicines," "drugstore," "pharmacy," or similar term or combination of terms shall be restricted to the area registered by the Board. Nothing in this restriction shall prevent the placement of signs on the outside of the establishment, indicating the presence of a drug outlet inside.

Section 9.5. Display of Licenses.

(a) The drug outlet's current license shall be displayed in a conspicuous manner visible to the public.

(b) All pharmacists, pharmacy interns, and pharmacy technicians shall display their current licenses or registrations in a conspicuous manner visible to the public.

(c) Pharmacists employed in more than one drug outlet may elect to have their current license displayed at either drug outlet. The wallet portion of the license must be available for examination by any consumer, Board inspector, or law enforcement officer upon demand.

Section 9.6. Name Tags and Identification.

(a) A pharmacist shall wear a name tag bearing in a clearly legible font the individual's name and title "Pharmacist."

(b) No pharmacist may verbally or by other means, identify his or her self as a "doctor" unless he or she possesses a doctoral level degree in pharmacy from an accredited school of pharmacy and clarifies that he or she is not a medical doctor.

Section 9.7. Security.

(a) Each pharmacist, while on duty, shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of drugs or devices.

(b) The pharmacy shall be secured by a physical barrier with suitable locks and an electronic barrier to detect entry and report the entry to appropriate persons at a time when the pharmacy is not open. The prescription department shall be secure from access by unauthorized personnel at all times. Only support personnel directly involved in the prescription dispensing process, non-pharmacist management, maintenance personnel, law enforcement personnel, or emergency services personnel shall be allowed entry into the prescription department only with the consent of the pharmacist who is present in the pharmacy.

(c) Prescription and other patient health care information shall be secure from access by the public, and the information shall be kept confidential. Prescriptions, orders, records, and stocks of regulated drugs shall be open for inspection to authorized agents of the Board ( 18 V.S.A. § 4211). A person who gives information to specifically authorized agents of the Board concerning the use of regulated drugs, or the misuse by other persons or regulated drugs, shall not be subject to any civil, criminal or administrative liability or penalty for giving such information ( 18 V.S.A. § 4218(c)).

Section 9.8. Hygiene Standards.

The drug outlet shall:

(a) comply with all federal, state, and local health laws;

(b) have walls, ceilings, windows, and floors kept clean and in good repair;

(d) have equipment kept clean and stored in an orderly manner;

(e) be well lighted;

(f) be dry and well ventilated;

(g) have adequate restroom facilities for employees.

Section 9.9. Drugs and Devices, Definitions.

(a) Adulterated: means consisting, in whole or in part, of any filthy, putrid, decomposed substance; or does not meet FDA standards.

(b) Misbranded: means outdated, or label is false or misleading, or does not meet FDA standards.

Section 9.10. Drugs Removed from Inventory.

Any drug or device that is misbranded, adulterated, or expired shall not be sold or given away and shall be removed from inventory and stored for no more than one year from the date of expiration in a separate location within the prescription drug area until processed for return or destruction.

Section 9.11. Recalled Drugs.

There shall be a system to monitor drug recalls and, where appropriate, to notify patients to whom the recalled drug products have been dispensed.

Section 9.12. Disposal of Controlled and Non-Controlled Substances.

The Board accepts Drug Enforcement Administration (DEA) approved reverse distribution organizations. A list may be obtained by contacting the Diversion Unit at the regional DEA office in Boston, Massachusetts. Telephone 888-2725174; fax 617-557-2126. The DEA list is compiled from applications for registration and is amended periodically.

Section 9.13. Drug Storage Areas.

All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the USP or the manufacturer's or distributor's labeling unless otherwise indicated by the Board.

Section 9.14. Equipment.

The pharmacy shall carry and utilize the equipment and supplies necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and comply with all state and federal laws. The pharmacy must have at a minimum the following equipment:

(a) A refrigerator with a temperature control and thermometer;

(1) The refrigerator shall have a thermometer and maintain temperature between 36 degrees F and 46 degrees F (+2 to + 8 Celsius). Unless electronically monitored on a continual basis, a logged compliance check at least monthly is required.

(2) Non- pharmacy related items may not be stored in the pharmacy refrigerator intended for medications.

(b) If the facility carries drugs which require storage in a freezer: the freezer temperature must be maintained at or below minus 15 degrees Celsius;

(d) An automated data processing system;

(e) At least one telephone in the prescription area, with the same number as the telephone number printed on the drug outlet prescription labels;

(f) A tablet and capsule counting tray;

(g) Containers which meet official compendia standards, available with closures that meet Federal Poison Prevention Packaging Act of 1970 requirements, as well as regular closures;

(h) Prescription labels imprinted or computer-generated with the name, address, and telephone number of the drug outlet that do not contain any symbol or background logo that interferes with the reading and interpretation of any information written by the pharmacist on the label;

(i) Auxiliary labels;

(j) equipment and supplies sufficient for the scope of practice; If needed for compounding: One class A prescription balance with metric weights from 10 milligrams to 50 grams or automatic sensitivity requirement of six mg. with no load, or an electronic balance.

(k) Any drug outlet involved in the preparation of sterile pharmaceutical products must meet the requirements of the Sterile Pharmaceuticals rules.

Section 9.15. Reference Library.

Each pharmacy shall maintain on file at least one reference in each of the categories listed below. Computerized, online versions are acceptable instead of a hard copy of the current manual only if made known and accessible to every pharmacist at the pharmacy. Whether in hard copy or computerized, this reference work must be complete and must include an explanation of drug interactions, either in the form of a manual or otherwise:

(a) State and federal drug laws relating to the practice of pharmacy, including a current copy of these statutes and rules, and the legal distribution of drugs and any rules or regulations adopted pursuant thereto;

(b) Current manual of drug interactions equivalent to Hansten's or Drug Facts, with quarterly updates, which has been pre-approved by the Board.

(d) Current reference on pediatric dosages;

(e) Pharmacies offering for sale herbal or alternative medicines, must possess a current reference for such; computerized version or hard copy.

Section 9.16. Inspection of Drug Outlets.

(a) Biennially, a Board member, a representative appointed by the Board, or an employee of or contractor with the Office of Professional Regulation, shall inspect a drug outlet in Vermont during regular business hours, for compliance with these rules. Deficiencies shall be handled in the manner set forth in Rule 7.2(i).

(b) The Board shall not authorize any inspection that extends to financial data, sales data other than shipping data or pricing data of the drug outlet.

Section 9.17. Persons Authorized to Prescribe.

Pharmacists may accept prescription legend drug orders from authorized practitioners within the United States and Canada. At the time these rules are adopted, authorized prescribers include:

(a) Dentist;

(b) Naturopathic physician, as authorized by law;

(d) Optometrist;

(e) Osteopath;

(f) Physician;

(g) Physician's assistant, as authorized by law;

(h) Podiatrist;

(i) Scientific investigator;

(j) Veterinarian;

(k) Certified Nurse Midwife as permitted by law; and

(l) Others as permitted by Vermont and federal law.

Section 9.18. Prescription Pick-Up and Delivery.

(a) A licensee may, upon request by the patient, accept or deliver a drug or device to the patient or licensed facility in which patient resides. Upon a showing of special circumstances, the Board may approve delivery to and pick up from a secure site in a medical facility under conditions set by the Board.

(b) The licensee may delegate the pick-up and delivery of prescription drugs and devices to an employee of the drug outlet, or the U.S. mail, or a common carrier. The drug or device shall be properly labeled as a finished dispensed prescription product.

Section 9.19. Advertising Prescription Drugs.

Prescription legend drug and device advertising shall be truthful, reasonable, informative, and understandable to the consumer. Advertisements for drugs at special prices for a limited time must state the termination date of the special price, and that prices may change after that date.

Section 9.20. Sale of Prescription Legend Drugs.

(a) Legend drugs may be sold or transferred to a licensed pharmacist, or practitioner qualified to prescribe, or drug outlet, or drug outlet owner, or manufacturer, wholesaler, or distributor of such drugs.

(b) The transaction shall be recorded on a written invoice or appropriate form and kept in the drug outlet. See, 26 V.S.A. §§ 2067 - 2076 (wholesale drug distributors) for requirements relating to wholesalers and 26 V.S.A. § 2022(16) for the definition of "wholesale distribution."

(c) The invoice shall contain the name, strength, form, and quantity of the drug, the date of sale, and the name and address of the seller and purchaser.

(d) If the product is a controlled substance, the invoice shall also include the DEA registration number of both the purchaser and seller. If the product is a Schedule II controlled substance and is sold or transferred, the purchaser or transferee must give a DEA 222 or its successor form to the supplier before the transfer/sale can proceed.

(e) Receipt, dispensing, and distribution records. Except as provided in this sub rule, a coordinating pharmacy shall maintain a record of all drugs received, dispensed, and distributed from the coordinating pharmacy and from each remote dispensing site.

Section 9.21. Pharmacist Meal/Rest Breaks.

(a) Whenever the prescription department is staffed by a single pharmacist, the pharmacist may take a meal/rest break for a period of up to 30 minutes without closing the pharmacy and removing support personnel from the pharmacy, provided that the pharmacist reasonably believes that the security of the prescription drugs will be maintained in the pharmacist's absence.

(b) No pharmacist shall work more than 8 hours without a meal/rest break. Breaks should be scheduled as close as possible to the same time each day, so that patients may become familiar with the approximate time of the breaks

(c) The pharmacist shall remain on the premises of the drug outlet during the meal/rest break and shall be available for emergencies.

(d) If two or more pharmacists are on duty in the prescription department, the pharmacists shall stagger their meal/rest breaks so that the prescription department is not left without a pharmacist on duty.

(e) Whenever the pharmacist temporarily leaves the prescription department for a meal/rest break, a sign indicating that there is no pharmacist on duty shall be conspicuously displayed.. The sign shall also indicate the time when the pharmacist will return.

(f) Only support personnel directly involved in the prescription dispensing process and authorized by the pharmacist on duty may remain in the prescription department while the pharmacist is on a meal/rest break.

(g) When the pharmacist is temporarily absent from the prescription department, support personnel authorized by the pharmacist on duty may continue to perform non-discretionary duties as delineated by the pharmacist. All such duties performed by support personnel shall be reviewed by the pharmacist upon return from the meal/rest break.

(h) When a pharmacist is not in the prescription department, there shall be no dispensing of new prescriptions that the pharmacist has checked and that are waiting to be picked up, nor shall counseling be provided by support personnel.

(i) New, written prescriptions presented by the patient or the patient's agent may be accepted by support personnel. The processing of such prescriptions, up to the final check, may occur in the absence of the pharmacist. However, no prescription may be dispensed until the final check is completed by the pharmacist after return to the prescription department.

(j) New prescriptions conveyed by telephone shall not be accepted by support personnel. The caller should be instructed to call back, or a telephone number should be obtained for the pharmacist to call upon return to the prescription department.

(k) During the pharmacist's absence, prescription refills which have been previously prepared and checked by a pharmacist may be picked up by the patient or the patient's agent. Support personnel must offer the patient counseling by the pharmacist. If the patient has no questions, dispensing may proceed as usual, with the patient signing for the counseling refusal. If the patient desires counseling, the patient should be asked to wait for the pharmacist to return from the meal/rest break. Alternatively, the patient may be asked to leave a telephone number for the pharmacist to call later the same day.

(l) Telephone refill orders and refill requests presented in person by the patient or the patient's agent may be accepted by support personnel. Such refill orders may be processed by support personnel up to the final check. However, no such refill orders shall be dispensed until the final check is completed by the pharmacist after return from the meal/rest break.

(m) Under this rule, the pharmacist-manager remains responsible for the direct management, supervision, and control of the prescription department.

(n) If, for security reasons or otherwise, the pharmacist determines that the prescription department should close during the pharmacist's absence, the pharmacist shall close the prescription department and remove all support personnel from the prescription department during the pharmacist's absence. A sign informing the public of the pharmacist's temporary absence and time of return shall be conspicuously posted.

(o) Using this rule as a guide, the pharmacist-manager, in conjunction with the pharmacy license holder, should develop written policies and procedures regarding operation of the prescription department while the pharmacist is temporarily absent on a meal/rest break.

(1) The policies and procedures should include authorized duties of support personnel and should define the pharmacist's responsibilities for checking all work performed by support personnel and for maintaining security of the prescription department. The pharmacist-manager should review the policies and procedures with support personnel.

(2) After review, each support person should be requested to initial the policies and procedures to indicate that the policies and procedures are understood.

PART 10 PHARMACY PRACTICE

Section 10.1. Prescription Drug Orders.

A Prescription drug order shall contain the following information at a minimum:

(a) Full name and street address of the patient (which may appear on the back of the prescription drug order);

(b) Name, address, facility or practice name where applicable, and telephone number, and, if a controlled substance, address and DEA registration number of the prescribing practitioner;

(d) Name, strength, dosage form, quantity or stop date, and route of administration of drug prescribed;

(e) Directions for use by patient;

(f) Number of authorized refills or specified time limit; if number of refills or time limit is not specified, prescription is non-refillable; and

(g) If a manually written prescription drug order, the prescribing practitioner's handwritten signature.

Section 10.2. Legitimate Prescriptions.

A prescription or drug order for a legend drug is not valid unless it is issued for a legitimate medical purpose arising from a prescriber-patient relationship which includes a documented patient evaluation adequate to establish diagnoses and identify underlying conditions and/or contraindications to the treatment. Treatment, including issuing a prescription or drug order, based solely on an online questionnaire or consultation outside of an ongoing clinical relationship does not constitute a legitimate medical purpose.

Section 10.3. End of Prescriber's Practice.

If a practitioner as defined in 26 V.S.A. § 2022(15) ceases to practice for any reason, a pharmacist may, pursuant to a prescription written by that practitioner, dispense all remaining refills up to a 90-day supply of the drug prescribed, to enable the patient to obtain the services of another practitioner.

Section 10.4. Allowed Forms of Prescription Drug Orders.

Prescription drug orders must be communicated directly to a pharmacist. This may be accomplished in one of the following ways.

(a) A prescription drug order, including that for a controlled substance listed in Schedules II through V, may be communicated in written, oral, or electronic form.

(b) A prescription drug order, including that for a controlled substance listed in Schedules III through V, and, in certain situations, that for a controlled substance listed in Schedule II, may be communicated orally (including telephone voice communication) or by way of electronic transmission as permitted by federal law provided the vendor of the software meets the requirements set forth by the DEA for authentication.

Section 10.5. Tamper Resistant Prescription Forms.

(a) Prescriptions shall be written so as to:

(1) prevent unauthorized copying of a completed or blank prescription form,

(2) prevent erasure or modification of information written on the prescription by the prescriber; and

(3) prevent the use of counterfeit prescription forms.

(b) Handwritten prescriptions must be written on a tamper resistant pad.

(c) Computer generated printed prescriptions must be printed on tamper resistant paper or other tamper proof methods as defined by the Centers for Medicaid and Medicare Services, including micro-printing and/or printing a "void" pantograph accompanied by a reverse "Rx," which causes a word such as "Void," "Illegal," or "Copy" to appear when the prescription is photocopied.

(d) Prescriptions written which comply with Medicaid rules will satisfy this rule.

(e) Prescription form features which will satisfy this rule could, for example, include the following properties:

(1) a colored background with a watermark;

(2) when photocopied read "void" in the background;

(3) have printed on the form the name of the prescriber or hospital identification and batch numbering with serially numbered pages for prescriptions;

Section 10.6. Loss of Prescription Pads or Forms.

Loss of any prescription pads or forms should be immediately reported to local law enforcement officials and the Board of Pharmacy.

Section 10.7. Prescriptions Not Hand Written.

If communicated orally or by way of electronic transmission, the prescription drug order shall be immediately reduced to a form by the pharmacist that shall be maintained for the time required by laws or rules.

Section 10.8. Schedule II Prescriptions.

(a) Except as provided below, a prescription drug order for a Schedule II controlled substance may be communicated in written form or electronically prescribed, provided the prescriber has proper software as certified by the DEA for this purpose. The electronic prescription order shall be maintained in accordance with the section below on patient records.

(b) A prescription drug order for a Schedule II controlled substance may be communicated by the practitioner by facsimile, provided the original written, signed prescription drug order is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in sub-sections or (c), (d) or (e) below in this section. The original, written prescription drug order shall be maintained in accordance with the section below on patient records.

(c) A prescription drug order for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be communicated by the practitioner or the practitioner's agent to a home infusion pharmacy by way of electronic transmission if permitted by federal law.

(d) A prescription drug order for a Schedule II controlled substance for a resident of a long term care facility may be communicated by the practitioner or the practitioner's agent by way of electronic transmission if permitted by federal law.

(e) A prescription drug order for a Schedule II narcotic substance for a resident under hospice care, no matter where provided, may be communicated by the practitioner or the practitioner's agent by way of electronic transmission as provided by federal law. The practitioner or the practitioner's agent must note on the prescription that the patient is a hospice patient.

(f) In an emergency situation, a prescription drug order for a Schedule II controlled substance may be communicated by the practitioner orally, provided that:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription drug order signed by the prescribing practitioner);

(2) The orally communicated prescription drug order shall be immediately reduced to writing by the pharmacist, and shall contain the information required in Rule 9.1 above on prescription drug orders;

(3) If the prescribing practitioner is not known to the pharmacist, he or she must make a reasonable effort to determine that the oral authorization came from a legal practitioner, which may include a callback to the practitioner using the practitioner's phone number as listed in the telephone directory or other good faith efforts to insure the practitioner's identity; and

(4) Within 7 days after authorizing an emergency oral prescription drug order, the prescribing practitioner shall cause a written prescription drug order for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of the sub-section above on prescription drug orders, the prescription drug order shall have written on its face "Authorization for Emergency Dispensing," and the date of the orally or electronically transmitted prescription drug order. The written prescription drug order may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist shall attach this written prescription drug order to the emergency oral prescription drug order which had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription drug order. The pharmacist shall notify the nearest office of the U.S. Drug Enforcement Administration if the prescribing practitioner fails to deliver a written prescription drug order.

Section 10.9. Electronic Transmission.

All prescription drug orders communicated by way of electronic transmission shall:

(a) Be transmitted directly to a pharmacist in a licensed pharmacy of the patient's choice with no intervening person having access to the prescription drug order. This does not apply to the electronic transmission intermediary.

(b) Provide the transmitter's phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law;

(d) Be deemed the original prescription drug order, provided it meets the requirements of Rule 10.1 herein.

Section 10.10. Authorized Agents for Oral Transmission.

Designated employees of practitioners qualified to prescribe drugs may transmit an order for a prescription via telephone. The practitioner shall be responsible for record keeping and the accuracy of the prescription information. Any new prescription drug order being transmitted by a practitioner or his or her agent by telephone and the identity of the person calling in the prescription must be received and documented by a pharmacist or sufficiently trained pharmacy intern.

Section 10.11. Electronic Signatures Required.

An electronic prescription transmission to a pharmacist in a licensed pharmacy requires the electronic signature of the prescriber.

Section 10.12. No Carbon or Duplicate Prescriptions.

Carbon or duplicate written prescriptions are not valid prescriptions. A written prescription must bear the original signature of the prescriber, not a copy or photo copy or stamp of the signature of the prescriber.

Section 10.13. Use of Independent Professional Judgment.

The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order communicated by way of electronic transmission consistent with existing federal or state laws and rules.

Section 10.14. Security of Electronic Equipment.

All electronic equipment for receipt of prescription drug orders communicated by way of electronic transmission shall be maintained in the pharmacy area so as to ensure against unauthorized access or observation.

Section 10.15. Unauthorized Access.

Persons other than pharmacists, pharmacy technicians, pharmacy interns and others specifically authorized by law shall have no access to pharmacy records containing confidential information or personally identifiable information concerning the pharmacy's patients.

Section 10.16. Filling Time Limits, Future Fill Dates.

(a) No prescription for a Schedule II controlled substance written without a future fill date may be filled more than 30 days after the date the prescription was issued.

(b) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. Each prescription must contain both the original date of issue and the future fill date. For guidance, refer to regulations implementing the federal Controlled Substances Act.

(c) No prescription for a Schedule II controlled substance written to be filled at a future date may be filled more than 90 days after the date the prescription was issued.

Section 10.17. One Year Limit.

No prescription for a non-controlled drug may be filled or refilled more than one year after the prescription was written.

Section 10.18. Transfer of a Prescription Drug Order.

(a) Pharmacies utilizing automated data processing systems shall satisfy all information requirements of a manual mode for prescription drug order transferal, except as noted in subsection (d) below. The transfer of original prescription drug order information for the purpose of refill dispensing is permissible between pharmacies subject to the following requirements:

(1) The information is communicated directly between two pharmacists and the transferring pharmacist records the following information:

(A) Write the word "Transferred" on the face of the invalidated prescription drug order;

(B) Record on the reverse side of the invalidated prescription drug order the name and address of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription drug order;

(D) A computerized prescription record which contains all of the elements of (A), (B), and (C) above is acceptable.

(b) The pharmacist receiving the transferred prescription drug order information shall reduce to writing the following:

(1) Write the word "TRANSFER" on the face of the transferred prescription drug order;

(2) Provide all information required to be on a prescription drug order pursuant to state and federal laws and rules, and include:

(A) Date of issuance of original prescription drug order;

(B) Original number of refills authorized on original prescription drug order;

(D) Number of valid refills remaining and date of last refill;

(E) Pharmacy's name, address, telephone number, and original prescription number from which the prescription drug order information was transferred; and

(F) First and last name of transferring pharmacist.

(G) A computerized prescription record which contains all of the elements of (A) through (F) above is acceptable.

(3) Systems providing for the electronic transfer of information shall not infringe on a patient's freedom of choice as to the provider of pharmaceutical care.

(c) Both the original and transferred prescription drug order shall be maintained for a period of three (3) years from the date of last refill.

(d) Pharmacies accessing a common electronic file or database used to maintain required dispensing information are not required to transfer prescription drug orders or information for dispensing purposes between or among pharmacies participating in the same common prescription file, provided, however, that any such common file shall contain complete records of each prescription drug order and refill dispensed, and, further, that a hard copy record of each prescription drug order transferred or accessed for purposes of refilling shall be generated and maintained at the pharmacy refilling the prescription drug order or to which the prescription drug order is transferred. A hard copy is not necessary as long as the electronic information is readily available and hard copies can be generated immediately upon request.

(e) Pharmacies with automated systems that are unable to meet the transfer requirements of this section may transfer prescriptions and document such transfers using a manual method.

(f) A pharmacist may transfer an unfilled prescription order to another pharmacy.

Section 10.19. Drug Product Selection by the Pharmacist.

(a) When a pharmacist receives a prescription for a drug which is listed either by generic name or brand name in the U.S. Department of Health and Human Services publication Approved Drug Products With Therapeutic Equivalence Evaluations (the "Orange Book"), the pharmacist shall select the lowest priced drug from the list which in his or her professional judgment is an generically equivalent drug product and which he or she has in stock, unless otherwise instructed by the purchaser or prescriber.

(b) The purchaser shall be informed by the pharmacist or his or her representative that an alternative selection as provided under subsection (a) of this section will be made unless the purchaser chooses to refuse the substitution.

(c) Any pharmacist substituting a generically equivalent drug shall charge no more than the usual and customary retail price for that selected drug. This charge shall not exceed the usual and customary retail price for the prescribed brand.

(d) If the prescriber does not wish substitution to take place, he or she shall clearly indicate "brand necessary" or "no substitution" on the prescription. In the case of an unwritten prescription, there shall be no substitution if the prescriber expressly indicates to the pharmacist that the brand name drug is necessary and substitution is not allowed. Pharmacists are advised to monitor changes to 18 V.S.A. §§ 4605 and 4606.

Section 10.20. Hospital/Health Care Facility Labeling Requirements.

All drugs dispensed for use by inpatients of a hospital or other health care or institutional facility, where the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements:

(a) The label of a single-unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

(1) The non-proprietary or proprietary name of the drug;

(2) The route of administration, if other than oral;

(3) The strength and volume, where appropriate, expressed in the metric system whenever possible;

(4) The control number and expiration date;

(5) Identification of the re-packager by name or by license number shall be clearly distinguishable from the rest of the label; and

(6) Special storage conditions, if required.

(b) When a multiple-dose drug distribution system exceeding a 24 hour supply is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information:

(1) Identification of the dispensing pharmacy;

(2) The patient's name;

(3) The date of dispensing;

(4) The non-proprietary or proprietary name of the drug dispensed; and

(5) The strength, expressed in the metric system whenever possible.

(d) Whenever any drugs are added to parenteral solutions, such admixtures shall bear a distinctive label indicating:

(1) Name of solution, lot number, and volume of solution;

(2) Patient's name;

(3) Infusion rate;

(4) Bottle sequence number or other system control number;

(5) Name and quantity of each additive;

(6) Date of preparation;

(7) Beyond-use date and time of parenteral admixture; and

(8) Ancillary precaution labels.

Section 10.21. Pharmacy Dispensed Drugs: Labels.

All drugs, except those dispensed under Rule 10.20 above shall be dispensed in a container whose label shall include:

(a) The name and address and telephone number of the pharmacy;

(b) The name of the patient, or, if the patient is an animal, the first and last name of the owner, name of animal, and species of animal;

(d) directions for use;

(e) The date of dispensing;

(f) Any cautions which may be required by federal or state law;

(g) The serial number of the prescription drug order;

(h) The name or initials of the dispensing pharmacist;

(i) The proprietary or generic name of the drug dispensed and its strength;

(j) The name of the manufacturer or distributor of the drug and;

(k) The expiration date of the drug, if it is less than one year from the date of dispensing.

See, 18 V.S.A. § 4064a(a)(2)(B).

Section 10.22. Centralized Prescription Processing.

(a) "Centralized prescription processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, drug utilization review, claims adjudication, refill authorizations, and therapeutic interventions.

(b) A pharmacy may perform or outsource centralized prescription processing services provided the parties:

(1) have the same owner; or

(2) have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract in compliance with federal and state laws and regulations; and

(3) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a prescription drug order.

(c) The parties performing or contracting for centralized prescription processing services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the Board for review upon request and that includes, but is not limited to, the following:

(1) a description of how the parties will comply with federal and state laws and regulations;

(2) the maintenance of appropriate records to identify the responsible pharmacist(s) in the dispensing and counseling process;

(3) the maintenance of a mechanism for tracking the prescription drug order during each step in the dispensing process;

(4) the maintenance of a mechanism to identify on the prescription label all pharmacies involved in dispensing the prescription drug order;

(5) the provision of adequate security to protect the confidentiality and integrity of patient information;

(6) the maintenance of a quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

(d) Pharmacies using centralized processing shall post a notice to the public advising that:

(1) the pharmacy employs centralized processing;

(2) the pharmacist who dispenses a prescription to a patient may not be the pharmacist who prepared it, and;

(3) that upon request, the pharmacy shall provide a further explanation of how centralized processing works.

Section 10.23. Drugs Compounded in a Pharmacy.

Except for sections (c) and (e) below which do not apply to compounded drugs for veterinary clinic use, parenteral and sterile product prescriptions shall be compounded as follows: (See, Part 13 for requirements for Sterile Pharmaceuticals.)

(a) For all compounded prescriptions, the pharmacist shall be responsible for all compounding records and the proper maintenance, cleanliness and use of all equipment used in compounding.

(b) Every pharmacist who engages in non-sterile drug compounding shall be proficient, in the art of compounding and shall maintain that proficiency through participation in seminars, studying appropriate literature and/or becoming certified by a compounding certification program. Also, every pharmacist who engages in drug compounding must practice in accordance with NABP's Good Compounding Practices.

(c) A prescription shall be compounded and dispensed only pursuant to a specific order for an individual patient issued by a prescriber. A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(d) A Pharmacist may not compound a drug that appears on the FDA List of Drugs Withdrawn or Removed from the Market for Safety Reasons or on the FDA List of Drug Products that Present Demonstrable Difficulties in Compounding.

(e) Pharmacists shall not offer compounded drug products to other State-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient, in limited quantities.

(f) In addition to the requirements in Rules 10.20 and 10.21, the label of compounded prescriptions shall also contain an expiration or beyond-use date.

(g) Pharmacists shall maintain a compounding record that contains at least the following information:

(1) the name, strength, quantity, and dosage form of the drug product compounded;

(2) the formula to compound, including mixing instructions, all ingredients and their quantities, and any additional information needed to prepare the compound;

(3) the prescription number or assigned internal identification number;

(4) the date of preparation;

(5) the manufacturer and lot number of each ingredient;

(6) beyond-use date;

(7) the name of the person who prepared the compound; and

(8) the name of the pharmacist who approved the compound;

(h) These records must be kept for 3 years and shall be readily available for Board inspection.

Section 10.24. Radiopharmaceuticals.

No radiopharmaceutical may be dispensed unless a label is affixed to the immediate container bearing the following information:

(a) The standard radiation symbol;

(b) The words "Caution - Radioactive Material"; and

(d) The radionuclide and chemical form;

(e) The activity and date and time of assay;

(f) The volume, if in liquid form;

(g) The requested activity and the calibrated activity;

(h) Patient name or space for patient name.

(1) Where the patient's name is not available at the time of dispensing, a 72-hour exemption is allowed to obtain the name of the patient.

(2) No later than 72 hours after dispensing the radiopharmaceutical, the patient's name shall become a part of the prescription drug order to be retained for a period of three years;

(i) The name and address of the nuclear pharmacy;

(j) The name of the practitioner; and

(k) The lot number of the prescription.

Section 10.25. Patient Records.

A patient record system shall be maintained by all pharmacies for patients for whom prescription drug orders are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information:

(a) Full name of the patient for whom the drug is intended;

(b) Street address and telephone number of the patient;

(d) Patient's gender;

(e) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record during the three years immediately preceding the most recent entry showing:

(1) the name of the drug;

(2) prescription number;

(3) name and strength of the drug;

(4) the quantity and date received; and

(5) the name of the prescriber.

(f) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.

Section 10.26. Allergy and Health Information.

The Pharmacist or certified pharmacy technician or intern shall make a reasonable effort to ascertain from the patient or the patient's representative the patient's known allergies, drug reactions, idiosyncrasies, chronic conditions, or disease states and current use of other drugs which may relate to prospective drug review. The information shall be recorded in the patient profile. It shall be updated periodically, but not less than once per year.

Section 10.27. Patient Records Retention.

A patient record shall be maintained for a period of not less than three years from the date of the last entry in the profile record. This record may be maintained either on paper or on electronic media.

Section 10.28. Records of Dispensing.

Records of dispensing for original and prescriptions for all drugs or devices are to be made and kept by pharmacies for three years. Records of dispensing for refill prescriptions may be kept in either hard copy or electronic format. Records of dispensing for new and/or refill prescriptions shall include, but not be limited to:

(a) Quantity dispensed for original and refills, if different from original;

(b) Date of dispensing;

(d) Identification of the pharmacist dispensing;

(e) Name and manufacturer of drug dispensed if drug product selection occurs and more than a 24-hour supply is dispensed; and

(f) Records of refills to date.

Section 10.29. Confidential Information.

Confidential information is to be handled in conformance with HIPAA federal regulations. Confidential information or personally identifiable information may be released to the patient or the patient's authorized representative, the prescriber or other licensed practitioner then caring for the patient, another licensed pharmacist, the Board or its representative, or any other person duly authorized by law to receive such information. Confidential information or personally identifiable information in the patient medication record may be released to others only on written release of the patient.

Section 10.30. Prospective Drug Review.

(a) A pharmacist shall review the patient record and each prescription drug order presented for dispensing for purposes of promoting therapeutic appropriateness by identifying:

(1) Over-utilization or under-utilization;

(2) Therapeutic duplication;

(3) Drug-disease contraindications;

(4) Drug-drug interactions (including serious interactions with non-prescriptive or over-the-counter drugs);

(5) Incorrect drug dosage or duration of drug treatment;

(6) Drug-allergy interactions; and

(7) Clinical abuse or misuse.

(b) Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the practitioner.

Section 10.31. Patient Counseling.

(a) Patient counseling is the effective oral consultation by the pharmacist, in the exercise of his or her professional judgment and consistent with state statutes and Board rules regarding confidential information, with the patient or caregiver, in order to improve therapy by ensuring the proper use of drugs and devices.

(b) Upon receipt of a new prescription drug order and following a review of the patient's record, a pharmacist, pharmacy technician, or pharmacy intern shall offer counseling with the pharmacist or pharmacy intern of matters which will enhance or optimize the patient's drug therapy. The discussion with the pharmacist or intern shall be in person, whenever practicable, or by telephone and shall include appropriate elements of patient counseling which may include the following:

(1) The name and description of the drug;

(2) The dosage form, dose, route of administration, and duration of drug therapy;

(3) Intended use of the drug and expected action;

(4) Special directions and precautions for preparation, administration, and use by the patient;

(5) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(6) Techniques for self-monitoring drug therapy;

(7) Proper storage;

(8) Prescription refill information;

(9) Action to be taken in the event of a missed dose; and

(10) Pharmacist comments relevant to the individual's drug therapy..

(c) Alternative forms of patient information may be used to replace patient counseling when verbal face-to-face counseling is not possible. Alternative forms of patient information may be used to supplement patient counseling when appropriate. Examples include written information leaflets, pictogram labels, video programs, etc.

(d) Each pharmacy shall post a notice advising, "You have the right to confidential consultation with a pharmacist about your prescription. If you wish, a confidential consultation will be provided."

(e) Patient counseling, as described above and defined in these rules, shall not be required for inpatients of a hospital or institution where other licensed health care professionals are authorized to administer the drug(s).

(f) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation and such refusal is documented.

Section 10.32. Adverse Drug Reactions.

Unless already reported by the patient to the practitioner, significant adverse drug reactions shall be reported by the pharmacist to the practitioner and, in either case, an appropriate entry on the patient's record shall also be made.

Section 10.33. Perpetual Inventory.

A perpetual inventory shall be maintained for at least two years for all Schedule II controlled substances. Electronic versions may be permitted if they provide a secure audit trail of entries.

Section 10.34. Schedule II Inventory.

All Schedule II controlled substances must be physically inventoried and documented at least once every thirty (30) days.

Section 10.35. Immunizations.

For patients 18 or older: A pharmacist or intern may administer a vaccine pursuant to a written protocol including emergency measures e.g., epinephrine and/or diphenhydramine based on a collaborative practice agreement or a patient-specific prescription from a licensed prescriber.

(a) A properly trained pharmacist or intern may administer vaccines to a patient 18 years of age or older.

(1) A pharmacist or intern must take an accredited training course on immunizations and keep proof of training on file in the pharmacy. The immunization course must, at a minimum, meet U.S. Center for Disease Control and Prevention (CDC) Guidelines and be accredited by the Accreditation Council for Pharmacist Education (ACPE) or AMA (American Medical Association) Category I approval or a similar health authority or professional body, and include preadministration education and screening, vaccine storage and handling, administration of medication, record-keeping, emergency response and reporting of adverse reactions.

(2) A pharmacist or intern must maintain current training in Basic Cardiac Life Support.

(b) In an emergency related to an immunization a pharmacist or intern may administer epinephrine and/or diphenhydramine without a practitioner's prescription.

(c) A pharmacist administering immunizations shall complete a minimum of two (2) hours of continuing education related to immunizations in each licensing period.

(d) Recording keeping and reporting requirements: Unless specifically required by federal or state law. a pharmacist shall maintain for ten (10) years the following documentation regarding each immunization administered:

(1) The name, address, and date of birth of the patient;

(2) Any known allergies;

(3) The date of administration and site of injection;

(4) The name, dose, manufacturer's lot number, and expiration date of the vaccine or, in an emergency, epinephrine or diphenhydramine;

(5) The name and address of the patient's primary health care provider;

(6) The name and address of the prescriber, if different from the patient's primary provider;

(7) The name of the pharmacist administering the immunization;

(8) A record of the pharmacist's consultation with the patient determining that the patient is eligible for immunization.

(e) The pharmacist shall provide:

(1) a notification to the patient's primary health care provider of the immunization administered; and,

(2) to comply with the 18 V.S.A. § 1129 's immunization registry, notice as required to the Vermont Department of Health.

Section 10.36. Independent Practice of Pharmacists.

A pharmacist may provide pharmacist care services outside of a licensed pharmacy if all the following conditions are met:

(a) the pharmacist has access to prescription records, patient profiles, or other relevant medical information for purposes of pharmacist care services and appropriately reviews such information before performing any such functions;

(b) access to the information described in paragraph (a) of this rule is secure from unauthorized access and use, and all access by pharmacists is documented; and

(c) a pharmacist providing pharmacist care services outside the premises of a licensed pharmacy shall maintain the records or other patient-specific information used in such activities in a readily retrievable form in a system that is secured and managed by the pharmacy with whom the pharmacist is providing such services or, if acting independent of a pharmacy, a secure system maintained by the pharmacist. Such records or information shall:

(1) provide accountability and an audit trail;

(2) be provided to the Board upon request; and

(3) be preserved for a period of at least three years from the date relied upon or consulted for the purposes of performing any such function.

PART 11 INSTITUTIONAL PHARMACY

Section 11.1. Introduction.

In addition to requirements set forth in other parts of these rules, the rules in this Part are specifically applicable to all institutions and institutional pharmacies as defined below..

Section 11.2. Definitions.

(a) "Institutional facility" means any organization whose primary purpose is to provide a physical environment for patients to obtain health care services, including but not limited to a(n):

(1) Hospital;

(2) Convalescent home;

(3) Nursing home;

(4) Extended or long-term care facility;

(5) Mental health facility;

(6) Rehabilitation center;

(7) Psychiatric center;

(8) Developmental disability center;

(9) Drug abuse treatment center;

(10) Family planning clinic;

(11) Penal institution or correctional facility;

(12) Hospice;

(13) Public health facility;

(14) Athletic facility; and

(15) Residential care home.

(b) "Institutional pharmacy" means any drug outlet licensed by the Board which provides pharmaceutical care to current residents or patients in an institutional facility where drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease (hereinafter referred to as "drugs") are dispensed, compounded, and distributed and pharmaceutical care is provided. A pharmacy that provides services to patients who do not reside in institutional settings (with the exception of a one-time dispensing upon discharge from an institution) cannot be classified as an "institutional pharmacy."

Section 11.3. Personnel.

The institutional pharmacy shall:

(a) Be under the direct supervision of a full-time Vermont licensed pharmacist-manager;

(b) Employ support personnel to perform technical and secretarial duties appropriate to their training and skill level;

(d) Employ registered pharmacy technicians as needed to perform appropriate tasks.

Section 11.4. Responsibilities of the Pharmacist-Manager.

The pharmacist-manager shall be responsible for:

(a) The safe and efficient distribution and control of all pharmaceutical products;

(b) Preparation, sterilization, and admixture of parenteral medications;

(d) Compounding within the institutional pharmacy;

(e) Participation in developing a formulary for the institution;

(f) Correct filling and labeling of containers;

(g) Supply and inventory of emergency antidote drugs, if not kept in the emergency room;

(h) Record keeping;

(i) Participation in the institution's patient care evaluation program;

(j) Cooperation with teaching and research programs in the institution;

(k) Implementation of the institution's policies and procedures;

(l) Efficient and effective messenger and delivery service within the institution regarding medication use;

(m) Setting quality assurance standards;

(n) Development and implementation of written policies and procedures; and

(o) Inspections of medication storage areas.

Section 11.5. Written Policies.

The pharmacist-manager shall develop and implement written policies and procedures for the safe and efficient distribution of drugs and for the provision of pharmaceutical care. An annual updated copy of such procedures shall be on hand for inspection by the Board. Written policies and procedures shall include:

(a) Duties of support personnel;

(b) Night cabinets;

(d) Distribution of pharmaceutical products;

(e) Disposition of adulterated, misbranded or discontinued drugs;

(f) Recall of drugs; and

(g) Storing and returning drugs brought into the institution by patients.

Section 11.6. Absence of Pharmacist.

During such times as an institutional pharmacy may be unattended by a pharmacist, arrangements shall be made in advance by the pharmacist-manager for provision of drugs to the medical staff and other authorized personnel of the institutional facility by use of night cabinets and, in emergency circumstances, by access to the pharmacy. A pharmacist must be "on call" during all absences.

Section 11.7. Night Cabinets/Temporary Storage.

In the absence of a pharmacist, drugs for distribution to patients shall be stored in a locked cabinet ("night cabinet") or other enclosure constructed and located outside of the pharmacy area, to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons. The pharmacist-manager shall, in conjunction with the appropriate committee of the institutional facility, develop inventory listings of those drugs to be included in the night cabinet(s) and determine who may have access, and shall insure that:

(a) Drugs are properly labeled;

(b) Only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements until a pharmacist is available;

(c) Whenever access to the cabinet occurs, date and time of access, written practitioner's orders and proofs-of-use are provided;

(d) All drugs in the night cabinet are inventoried by a pharmacist or designee no less than once per week;

(e) A pharmacist reviews all medication orders for drugs removed from the night cabinet within 24 hours of their removal;

(f) A complete audit of all activity concerning the night cabinet is conducted no less than once per month; and (g) Written policies and procedures are established to implement the requirements of this section.

Section 11.8. Access to Pharmacy during Emergency.

The institutional pharmacy shall be secure from access by unauthorized persons at all times. Whenever any drug is not available from floor supplies or night cabinets, and the drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from the pharmacy in accordance with the requirements of this section.

Section 11.9. Designated Nurse Access.

(a) One supervisory nurse in any given eight-hour shift is responsible for obtaining drugs from the pharmacy.

(b) The responsible nurse shall be designated in writing by the appropriate committee of the institutional facility.

Section 11.10. Nurse Removal of Drugs.

Removal of any drug from the pharmacy by an authorized nurse must be recorded on a suitable form showing:

(a) patient name;

(b) room number;

(d) strength, amount,

(e) date and time of removal, and

(f) signature of nurse.

Section 11.11. Doses.

Doses should be in unit-of-use (unit-dose) packaging whenever possible. The physician order shall be left in the institutional pharmacy with the container from which the drug was removed, as notice to the next pharmacist on duty. The amount should be sufficient only for the patient's emergency needs.

Section 11.12. Emergency Kits.

An institutional facility lacking an institutional pharmacy may provide drugs from emergency kits. The drugs may be administered by authorized personnel, provided that such kits meet the following requirements:

(a) Emergency kits contain those drugs which may be required to meet the immediate therapeutic needs of patients;

(b) The drugs are not available from any other authorized source in sufficient time to prevent risk of harm to patients;

(d) All emergency kit drugs are equipped with a breakable seal, are sealed by a pharmacist, and are secure from access by unauthorized personnel;

(e) The supplying pharmacist, nursing staff, and the medical staff of the institutional facility shall jointly determine the drugs, by identity and quantity, to be included in emergency kits;

(f) The emergency kits shall be stored in secured areas to prevent unauthorized access and to ensure a proper environment for preservation of drugs in the kits;

(g) The exterior of each emergency kit shall be labeled so as to clearly indicate that it is an emergency drug kit and that it is for use in emergencies only.

(h) The label on the emergency kit shall contain a listing of the drugs contained in the kit, including name, strength, quantity, earliest expiration date and the name, address(es) and telephone number(s) of the supplying pharmacist;

(i) Drugs shall be removed from emergency kits pursuant to a valid prescription drug order only;

(j) Whenever an emergency kit is opened, the supplying pharmacist shall be notified within 24 hours, and the pharmacist shall ensure that the kit is restocked and resealed within a reasonable time so as to prevent risk of harm to patients;

(k) The expiration date of an emergency kit shall be the earliest date of expiration of any drug supplied in the kit. Upon the occurrence of the expiration date, the supplying pharmacist shall replace the expired drug; and

(l) The pharmacist and medical staff shall develop and implement written policies and procedures for using emergency drug kits.

Section 11.13. Emergency Kits in Non-Federal Registered Long-term Care Facilities (LTCF).

(a) An LTCF may obtain controlled substances for emergency kits from a DEA-registered hospital, clinic, pharmacy, or practitioner.

(b) An LTCF must have security safeguards for each emergency kit stored in the LTCF which include the designation of individuals who may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.

Section 11.14. Emergency Kit Records.

The LTCF and the providing registered DEA hospital, clinic, pharmacy, or practitioner must maintain complete and accurate records of the controlled substances placed in the emergency kits and the disposition of these controlled substances, and must take periodic physical inventories.

Section 11.15. Authorized Emergency Kit Users.

Controlled substances in emergency kits may be administered to patients in an LCTF only by personnel expressly authorized by an individual practitioner and in compliance with federal regulations on controlled substances.

(a) It is the Board's intent that the last person to inspect and seal an emergency drug kit must be a pharmacist. This task may not be delegated to a technician or a nurse. To further clarify this point, if the emergency drug kit is to be exchanged in its entirety and leaves the pharmacy after being sealed by a pharmacist, the intent of the rules has been met.

(b) If the drugs in the emergency drug kit are individually sealed in tamper proof containers, such as plastic cubes which are sealed either by plastic locks or tamper evident tape, then individual drugs may be "swapped" out of kits as long as they are properly labeled and it is done by authorized personnel.

(c) A nurse or technician at the long term care facility may replenish emergency drug kits with a drug item, provided the drug item is pre-sealed in an individual container and placed in a pre-designated part of the kit. This requirement is to prevent loose unit-dosed medications from being placed in the wrong locations in an emergency drug kit.

Section 11.16. Physical Requirements.

The institutional pharmacy shall meet the same standards as a retail drug outlet.

(a) Prescription area: The pharmacist-manager, or the pharmacist designated by him or her, shall have 24 hour access to the institutional pharmacy. The prescription area shall be large enough to properly store and prepare a prescription. The Board recommends 200 square feet.

(b) If the institutional facility is open at times when the institutional pharmacy is closed, the pharmacy must be permanently enclosed by a partition or Board-approved barrier device from floor to ceiling, or at least nine feet six inches in height, whichever is less.

(c) The institutional pharmacy must be secure from access when the institutional facility is closed. It must be secure from access by unauthorized personnel at all times. Only support personnel directly involved in the prescription dispensing process and non-pharmacist management shall be allowed entry into the institutional pharmacy and then only when a pharmacist is present in the institution.

(d) The prescription counter shall be kept free of any items not being used in the practice of pharmacy. No television monitors shall be located in the institutional pharmacy, and no such equipment shall be placed so as to distract the pharmacist from the practice of pharmacy. The aisle space behind the prescription counter shall be wide enough to allow free movement and shall be kept free of obstructions. The institutional pharmacy shall have a sink of appropriate size, exclusive of drain board area, necessary to fulfill the needs of the pharmacy. The sink shall be connected to hot and cold running water and shall have a working drain.

Section 11.17. Hygiene Standards.

The institutional pharmacy shall:

(a) comply with all federal, state, and local health laws;

(b) have walls, ceilings, windows, and floors kept clean and in good repair;

(d) have equipment kept clean and stored in an orderly manner;

(e) be well lighted;

(f) be dry and well ventilated; and

(g) have adequate restroom facilities for employees.

Section 11.18. Equipment.

The following equipment and miscellaneous supplies shall be present:

(a) One class A prescription balance with weights or automatic sensitivity requirement of six mg. with no load;

(b) One set of metric weights from 10 milligrams to 50 grams;

(d) Distilled and/or sterile water;

(e) An automated data processing system;

(f) At least one telephone in the prescription area, with the same number as the telephone number printed on the drug outlet prescription labels;

(g) A tablet and capsule counting tray;

(h) Containers which meet official compendia standards, available with closures that meet Federal Poison Prevention Packaging Act of 1970 requirements, as well as regular closures;

(i) Prescription labels imprinted or computer-generated with the name, address, and telephone number of the institutional pharmacy that do not contain any symbol or background logo that interferes with the reading and interpretation of any information written by the pharmacist on the label;

(j) Auxiliary labels;

(k) Prescription filing devices for record keeping;

(l) Sufficient equipment, graduates, mortars, funnels, etc., to maintain the scope of practice;

(m) A current copy of the Vermont Pharmacy Laws and Rules and Regulations;

(n) Any institutional pharmacy involved in the preparation of sterile pharmaceutical must meet the requirements of the "Sterile Pharmaceuticals" provisions of these rules; and

(o) Telephone number of a poison control center.

Section 11.19. Reference Materials.

Each pharmacy shall maintain on file at least one reference in each of the following categories. Computerized, on-line versions are acceptable instead of a hard copy of the current manual. Whether in hard copy or computerized, this reference work must be complete and must include an explanation of drug interactions, either in the form of a manual or otherwise:

(b) Current manual of drug interactions equivalent to "Hansten's" or "Drug Facts," with quarterly updates, which has been pre-approved by the Board.

(d) Current reference on pediatric dosages;

(e) IV admixture compatibility reference (such as "King's Guide to Parenteral Admixtures");

(f) Injectable Drug Handbook ("Trissel's"); and

(g) American Hospital Formulary Service Drug Information text.

Section 11.20. Storage.

All drugs shall be stored in designated areas within the institutional pharmacy, at temperatures recommended by the U.S. Pharmacopoeia.

Section 11.21. Security.

The institutional pharmacy shall be locked by key or combination when unattended.

Section 11.22. Labeling.

All drugs dispensed for use within the institution shall:

(a) Be in appropriate containers; and

(b) Be labeled with the patient's name, patient's location, brand or generic name, strength, quantity of drug, and expiration date.

Section 11.23. Dispensed Drugs.

All drugs dispensed for use outside the institution shall comply with standards set for a retail drug outlet.

Section 11.24. Unit Dose Packaging.

All drugs shall be in unit dose packaging specifying drug name, strength, and expiration date. Either the drug manufacturer and lot number must be labeled on the package, or there must be a system that allows for retrieval of such information.

Section 11.25. Discontinued Drugs.

All discontinued, outdated, or misbranded drugs shall be returned to the institutional pharmacy and properly disposed of by the pharmacist-manager or his or her authorized designee.

Section 11.26. Physician's Orders.

Drugs may be dispensed from the institutional pharmacy if:

(a) Ordered by an authorized practitioner;

(b) The drug order includes the name and location of the patient, name and dosage of the drug, directions for use, date of order, and signature of the physician or his or her authorized designee;

(c) Telephone or verbal orders are transcribed into the patient record and noted as a telephone or verbal order. Telephone or verbal orders shall be countersigned by the prescribing physician within 30 days. The authority to receive telephone or verbal orders must be officially granted in the institutions' rules and regulations or medical staff bylaws.

(d) All abbreviations and symbols used in written orders are approved for use by the institution.

(e) Pharmacists may adjust medication doses if the order is part of a medication or dosing protocol that has been approved by the medical staff of the institution. This section should not be construed as giving prescribing privileges to pharmacists.

Section 11.27. Telephone Orders.

Prescription orders issued by an authorized practitioner may be telephoned to a retail drug outlet by a licensed registered or practical nurse.

Section 11.28. Controlled Drug Accountability.

The following information must be recorded each time a controlled drug is administered;

(a) Name of drug;

(b) Dosage;

(d) Date and time the drug was administered;

(e) Name of person administering the drug; and

(f) Name of prescriber.

Section 11.29. Recall.

All recalled drugs and pharmaceutical devices shall be retrieved from within the institution for safe and proper disposal in the institutional pharmacy.

Section 11.30. Adverse Drug Reactions.

All adverse drug reactions shall be reported to the patient's physician and documented in the patient chart and shall also be entered into the patient profile.

Section 11.31. Medications Brought into the Institution by Patients.

Drugs brought into an institutional facility by a patient shall not be administered unless they can be identified and the quality of the drug assured. If such drugs are not to be administered, then the pharmacist-manager shall, according to procedures specified in writing, have them turned in to the pharmacy, which shall package and seal them and return them to an adult member of the patient's immediate family, or store and return them to the patient upon discharge.

Section 11.32. Investigational Drugs.

Investigational drugs shall be stored in and dispensed from the pharmacy only. Investigational drugs may be administered if:

(a) Prior approval of the protocol has been granted by the institution's investigational drug review board or committee;

(b) Informed consent to treatment with these drugs has been given in writing by the patient or authorized representative;

(c) Administered under the direct and personal supervision of the principal physician-investigator, or his or her authorized clinician, or a nurse educated and trained in administration of investigational drugs;

(d) All essential information pertaining to the investigational drug is maintained, stored, updated, and dispensed by the institutional pharmacy;

(e) The institution participating in investigational studies assures that such studies contain adequate safeguards for the patient, the institution, and the scientific integrity of the study;

(f) The institution participating in investigational studies has written policies and procedures for the approval, management, and control of these studies; and

(g) The pharmacist is responsible to the institution and to the principal investigator for seeing that procedures for the control of investigational drug use are developed and maintained.

Section 11.33. Records and Reports.

The following records and reports shall be kept on file for three years and submitted to the Board upon request:

(a) The practitioner's orders, or direct copies. The ability to retrieve these orders from a patient's medical record is acceptable;

(b) Records of medications dispensed;

(d) Inventories of night cabinets, emergency kits, the institutional pharmacy, and controlled substances;

(e) Alcohol and flammables reports;

(f) Authorized removal of drugs from the institutional pharmacy by a nurse.

Section 11.34. Inspection of Medication Areas.

Every month, the pharmacist-manager or his or her qualified designee shall inspect all matters for which he or she is responsible, to verify compliance with these rules, and document the following:

(a) Drugs are dispensed only under the direct supervision of a licensed pharmacist;

(b) Support personnel are properly directed and supervised;

(d) Compliance with all special storage conditions for each drug;

(e) Outdated drugs are not stocked in the institution or the institutional pharmacy;

(f) Distribution and administration of controlled substances are adequately documented by pharmacy, medical, and nursing personnel;

(g) There is an adequate supply of emergency drugs;

(h) All security and storage standards are met;

(i) Metric-apothecary weight and measure conversion tables and charts are reasonably available to all medical and nursing personnel; and

(j) Compliance with policies and procedures pertaining to the pharmacy.

PART 12 COMPUTER SYSTEMS AND AMDS USAGE

Section 12.1. Permitted Practices.

Computer systems for data processing may be used for record keeping in licensed pharmacies, if:

(a) Patient records may be viewed at any time on the computer screen;

(b) Patient records are available as printed documents;

(d) An auxiliary record keeping system is established for use when the computer system is temporarily inoperable, and such records are entered into the system when operations are restored;

(e) A backup copy must be kept off-site or in fire-proof storage;

(f) A software provision must be implemented that will flag or otherwise warn of allergies or medication interactions.

Section 12.2. Common Files or Data Bases.

Pharmacies accessing a common electronic file or database used to maintain required dispensing information are not required to transfer prescription drug orders or information for dispensing purposes between or among pharmacies participating in the same common prescription file. Provided, however, that any such common file shall contain complete records of each prescription drug order and refill dispensed and further, that a hard copy record of each prescription drug order accessed for purposes of refilling shall be generated and maintained at the pharmacy refilling the prescription drug order.

Section 12.3. Printouts.

The computerized system shall have the capability of producing a printout of any prescription drug order data. The system shall provide a refill-by-refill audit trail for any specified strength and dosage form of any drug. Such an audit trail shall be by printout, and include the name of the prescribing practitioner, name and location of the patient, quantity dispensed on each refill, date of dispensing of each refill, name or identification code of the dispensing pharmacist, and unique identifier of the prescription drug order.

Section 12.4. Retrievability.

Any facility maintaining centralized prescription records shall be capable of sending a requested printout to the pharmacy within 72 hours.

Section 12.5. Sight Readable Information.

The system shall have the capability of producing sight-readable information on all original and refill prescription drug orders. The term "sight-readable" means that an authorized individual shall be able to examine the record and read the information from the computer monitor, microfiche, microfilm, printout, or other method acceptable to the Board.

Section 12.6. On-Line Retrieval.

The system shall provide on-line retrieval (via computer monitor or hard-copy printout) of original prescription drug order information. The information shall include, but not be limited to, the prescription drug order requirements and records of dispensing as indicated in these rules.

Section 12.7. Daily Records.

Each pharmacist responsible for dispensing shall create a retrievable record of each day's prescription drug order information. The pharmacist shall in a log book sign a daily verification that prescription information in the record is correct. The verification shall be dated and signed in the same manner as signing a check or legal document (e.g., J.H. Smith or John H. Smith) by the individual pharmacist. Daily records shall be retained for three years.

Section 12.8. Automated Systems.

If an automated pharmacy system is used the pharmacist-manager shall have the ultimate responsibility to:

(a) Assign, discontinue, or change access to the system;

(b) Ensure that access to the medications comply with state and federal regulations;

(c) Ensure that the automated pharmacy system is filled and stocked accurately and in accordance with established, written policies and procedures.

(d) If an automated dispensing system is utilized in the LTCF, only those systems that are designed to prevent improper placement of medications may be utilized.

Section 12.9. Personnel.

The filling and stocking of all medications in the automated pharmacy system shall be accomplished by qualified personnel under the supervision of a licensed pharmacist.

Section 12.10. Records.

A record of medications filled or stocked into an automated pharmacy system shall be maintained and shall include identification of the persons filling or stocking and checking for accuracy. These records shall be maintained for three (3) years.

Section 12.11. Dispensing and Distributing.

(a) All drugs stored in an AMDS shall be packaged and labeled as required by federal and state statutes and regulations.

(b) All aspects of handling controlled substances dispensed via an AMDS shall comply with applicable state and federal statutes and regulations.

Section 12.12. Confidentiality.

To maintain the confidentiality of patient records, the system shall have adequate security and systems safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. Once the drug has been dispensed, any alterations in prescription drug order data shall be documented, including the identification of the pharmacist responsible for the alteration.

Section 12.13. Automated Pharmacy System Records in Institutions.

Records and electronic data kept by the automated pharmacy system shall meet the following requirements:

(a) All events involving the contents of the automated pharmacy system must be recorded electronically.

(b) Records must be maintained by the pharmacy and must be readily available to the Board or its agent. Such records shall include:

(1) Identity of system accessed;

(2) Identification of the individual accessing the system;

(3) Type of transaction;

(4) Name, strength, dosage form, and quantity of the drug accessed; and

(5) Name of the patient for whom the drug was ordered.

Section 12.14. AMDS Records.

(a) Records and/or electronic data kept by Automated Pharmacy Systems shall be maintained at the AMDS site and must be readily available to the Board. Such records shall include:

(1) identification of the individual accessing the system;

(2) the date the AMDS was accessed,

(3) the name, strength, dosage form, and quantity of the Drug accessed;

(4) the name of the patient for whom the Drug was ordered; and

(5) A record of medications filled/stocked into an AMDS and identification of the persons filling/stocking and checking for accuracy.

(6) such additional information as the coordinating pharmacist may deem necessary.

(b) Records must be maintained and retrievable a minimum of three years.

Section 12.15. System Backup.

(a) Routine backup systems and procedures (hard copy, copy, disk, etc.) shall be in place and operational to ensure against loss of patient data.

(b) In the event that permanent dispensing information is lost due to unscheduled system interruption, the Board of Pharmacy shall be notified within 72 hours.

Section 12.16. Policies and Procedures.

(a) A remote pharmacy must be operated pursuant to policies and procedures adopted by the coordinating pharmacy.

(b) The policies and procedures shall require on-going documentation by the coordinating pharmacist manager to assure:

(1) that access to the AMDS is available to registered or licensed pharmacy personnel or AMDS maintenance personnel only;

(2) that the automated pharmacy dispensing system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed

(3) appropriate record keeping and security safeguards, and

(4) a mechanism for securing and accounting for medications removed from and subsequently returned to the AMDS; and

(5) a mechanism for securing and accounting for wasted medications or discarded medications; and

(6) patient confidentiality.

Section 12.17. Oral Communication of Prescriptions.

Designated employees of practitioners qualified to prescribe drugs may transmit an order for a prescription via telephone.

PART 13 STERILE PHARMACEUTICALS

Section 13.1. Purpose and Scope.

The purpose of this section is to assure positive patient outcomes through the provision of standards for (1) pharmaceutical care, (2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of a prescription drug order, and (3) product quality and characteristics, such as sterility and potency, that would be associated with environmental quality, preparation activities, and checks and tests carried out in the pharmacy.

Section 13.2. Applicability.

These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor's office). All requirements of this rule shall apply to any pharmacy engaged in the preparation of sterile pharmaceutical products.

Section 13.3. Definitions.

(a) "Compounding Aseptic Containment Isolator" also known as "biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

(b) "ISO 5" (International Organization for Standards) means an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air, according to Federal Standard 209E.

(d) "Enteral" means within or by way of the intestine.

(e) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin.

(f) "Positive patient outcomes" include the cure or prevention of disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process so as to improve the patient's quality of life.

(g) "Product quality and characteristics" include: sterility, potency associated with environmental quality, preparation activities, and checks and tests.

(h) "Sterile pharmaceutical" means any dosage form devoid of viable microorganisms, including, but not limited to, parenterals, injectables, and ophthalmics.

(i) "USP 797" means the current version of USP-NF General Chapter 797 Pharmaceutical Compounding - Sterile Preparations published annually by the U.S. Pharmacopeial Convention.

Section 13.4. Policy and Procedure Manual.

A policy and procedure manual shall be prepared and maintained for the compounding, dispensing, delivery, administration, storage, and use of sterile pharmaceutical prescription drug orders.

(a) The policy and procedure manual shall include a quality assurance program for the purpose of monitoring patient care and pharmaceutical care outcomes, adverse drug reactions, personnel qualifications, training and performance, product integrity, equipment, facilities, infection control, and guidelines regarding patient education.

(b) The policy and procedure manual shall be current and available for inspection by a Board-designated agent.

Section 13.5. Physical Requirements.

The pharmacy shall have a designated area with entry restricted to designated personnel for preparing parenteral products. This area shall be:

(a) structurally isolated from other areas with restricted entry or access;

(b) be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled facility;

(d) of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

Section 13.6. ISO 5 Compliance.

The pharmacy preparing parenteral products shall have:

(a) appropriate environmental control devices capable of maintaining at least ISO 5 conditions in the workplace where critical objects are exposed and critical activities are performed; furthermore, these devices are capable of maintaining ISO 5 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air;

(b) Appropriate disposal containers for used needles, syringes, etc., and if applicable, for cytotoxic waste from the preparation of chemotherapy agents and infectious wastes from patients' homes;

(c) When cytotoxic drug products are prepared, appropriate environmental control also includes appropriate biohazard cabinetry;

(d) Temperature-controlled delivery container if products are to be stored unrefrigerated for more than two hours; and

(d) Infusion devices, if appropriate.

Section 13.7. Supplies.

The pharmacy shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

Section 13.8. Reference Materials.

The pharmacy shall maintain on file at least one current reference related to preparation of sterile products, equivalent to "Trissel's" or "King's."

Section 13.9. Records and Reports.

In addition to standard record and reporting requirements, the following additional records and reports must be maintained for sterile pharmaceuticals:

(a) A policy and procedure manual, including policies and procedures for cytotoxic or infectious waste, or both, if applicable, and

(b) Lot numbers of the components used in compounding sterile prescriptions, except for preparations made for a specific patient and which will be used within 30 days.

Section 13.10. Delivery Service.

The pharmacist-manager shall assure the environmental control of all products shipped. Any compounded, sterile pharmaceutical must be shipped or delivered to a patient in appropriate temperature-controlled (as defined by USP Standards) delivery containers and stored appropriately in the patient's home.

Section 13.11. Emergency Kit.

When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy may supply the nurse or patient with emergency drugs, if the physician has authorized the use of these drugs by a protocol, in an emergency situation (e.g., anaphylactic shock).

Section 13.12. Cytotoxic Drugs.

In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved:

(a) All cytotoxic drugs should be compounded in a vertical flow, Class II, Compounding Aseptic Containment Isolator. Other products should not be compounded in this cabinet.

(b) Protective apparel shall be worn by personnel compounding cytotoxic drugs. This shall include disposable masks, gloves, and gowns with tight cuffs.

(c) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.

(d) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.

(e) Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.

(f) Prepared doses of cytotoxic drugs shall be dispensed, labeled with proper precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.

Section 13.13. Disposal of Cytotoxic or Hazardous Wastes.

The pharmacist-Manager is responsible for assuring that there is a system for the disposal of cytotoxic or infectious waste in a manner so as not to endanger the public health.

Section 13.14. Patient Education and Training.

If appropriate, the pharmacist must document the patient's training and competency in managing this type of therapy provided by the pharmacist to the patient in the home environment. A pharmacist must be involved in the patient training process in any area that relates to drug compounding, labeling, administration, storage, stability, compatibility, or disposal. The pharmacist must be responsible for seeing that the patient's competency in the above area is reassessed on an ongoing basis.

Section 13.15. Quality Assurance for Compounding and Preparation of Sterile Pharmaceuticals.

There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and facilities. Appropriate samples of finished products shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.

Section 13.16. Sanitation Standards - Certification of Compliance.

All clean rooms and laminar flow hoods shall be certified by an independent contractor according to ISO Standard 14644 for operational efficiency at least every six months. Appropriate records shall be maintained.

Section 13.17. Written Protocol.

There shall be written procedures developed requiring sampling if microbial contamination is suspected.

Section 13.18. End Product Testing.

If bulk compounding of parenteral solutions is performed using non-sterile chemicals, extensive end-product testing must be documented prior to the release of the product from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.

Section 13.19. Beyond Use Dates.

There shall be written justification of the chosen beyond-use dates for compounded products.

Section 13.20. Quality Assurance Audits.

There shall be documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits.

Section 13.21. Pharmaceutical Care Outcomes.

There shall be a documented, ongoing quality assurance control program that monitors patient care and pharmaceutical care outcomes, including but not limited to the following:

(a) Routine performance of prospective drug use review and patient monitoring functions by a pharmacist;

(b) Patient monitoring plans that include written outcome measures and systems for routing patient assessment (examples include infection rates, rehospitalization rates, and the incidence of adverse drug reactions);

(d) Appropriate collaboration with other health care professionals.

Section 13.22. USP 797 Compliance for Compounded Sterile Products.

(a) All pharmacies, either in state or out of state, dispensing or distributing compounded sterile products as defined by USP 797 to Vermont patients, institutions or providers shall meet all requirements of USP 797.

(b) Such pharmacies shall file with the Board proof of USP 797 compliance or an affidavit describing their procedures for quality assurance, sterilization methods, environmental controls, sterility and pyrogen testing, and maintenance of the quality of sterile products throughout packaging, handling, and distribution. The Board may conduct audits of any licensee.

PART 14 LICENSING OF INVESTIGATIVE AND RESEARCH PROJECTS

Section 14.1. Licenses Required.

Licensing of Investigative and Research Projects is required by 26 V.S.A. § 2061 (5). A legitimate institution or entity which possess prescription drugs in the course of conducting research or investigation shall apply to the Board for a license. The Board may issue a license when it determines that:

(a) The entity requesting the license is a legitimate research entity, recognized by state or national licensing or accreditation organizations approved by the Board;

(b) The entity explains with its application;

(1) where and how regulated drugs used for research or investigation will be stored, secured, and accounted for,

(2) who will be responsible for ensuring compliance with the requirements of this rule and;

Section 14.2. Conditions.

The Board may set reasonable conditions on licenses granted under this section.

The license holder will notify the Board within 5 working days if there is a change in the person responsible for compliance.

Section 14.3. Exemptions.

Medical facilities such as clinics and physicians' offices which are otherwise legally entitled to possess prescription drugs or are otherwise licensed by this Board are not required to be licensed under this Part 13 of the rules.

PART 15 NUCLEAR/RADIOLOGIC PHARMACY

Section 15.1. Purpose and Scope.

The practice of nuclear/radiologic pharmacy is a specialty of pharmacy practice regulated by the Board. Nuclear/radiologic pharmacy practice refers to a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.

Section 15.2. Definitions.

(a) "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.

(b) "Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.

(c) "Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services or, as provided in Rule 14.3 below, the appropriate area of any institutional facility.

(d) "Qualified licensed professional" means a non-pharmacist individual (such as a physician, nurse, or technologist) who possesses a current state license, if applicable, and who has sufficient training and experience to safely handle and dispense radiopharmaceuticals as defined by the Board.

(e) "Qualified nuclear pharmacist" means a currently licensed pharmacist in Vermont who is certified as a nuclear pharmacist by a certification board recognized by the Board, or who meets the following standards:

(1) Minimum standards of training for "authorized user status" of radioactive material, as defined by the Vermont Department of Health (VDH).

(2) Completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a program approved by the Board, with emphasis on the following areas:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(D) Radiation biology; and

(E) Radiopharmaceutical chemistry.

(3) Attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist.

(f) "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

(g) "Radiopharmaceutical service" means, but shall not be limited to, the procurement, storage, handling, preparation, labeling, quality assurance testing, dispensing, delivery, record keeping, and disposal of radiopharmaceuticals and other drugs.

(h) "Radiopharmaceuticals" are radioactive drugs as defined by the FDA.

Section 15.3. General Requirements for Pharmacies Providing Radio-Pharmaceutical Services.

(a) A license to operate a pharmacy providing radio-pharmaceutical services shall be issued only to a qualified nuclear pharmacist.

(b) All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist.

(c) A qualified nuclear pharmacist shall be responsible for all operations of the pharmacy and shall be in personal attendance at all times that the pharmacy is open for business.

(d) In emergency situations when a qualified nuclear pharmacist is not present, designated qualified licensed professionals may have access to the licensed area. These individuals may prepare single doses of radiopharmaceuticals for the immediate emergency, and must document such activities.

Section 15.4. Physical Requirements.

Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in Vermont or as otherwise defined by the Board.

Section 15.5. Security.

The nuclear pharmacy area shall be secured from unauthorized personnel.

Section 15.6. Records.

Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials in accordance with the requirements of the Vermont Department of Health.

Section 15.7. Radioactive Storage.

All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area. Detailed floor plans shall be submitted to the Board and the Vermont Department of Health before approval of the certification to practice nuclear pharmacy.

Section 15.8. Prescriptions.

Radiopharmaceuticals are to be dispensed only upon a prescription drug order from a practitioner authorized to possess, use, and administer radiopharmaceuticals.

Section 15.9. Permit Prerequisites.

The permit to operate a nuclear pharmacy is conditioned upon an approved Vermont Department of Health (VDH) or Nuclear Regulatory Commission (NRC) license. Copies of the VDH or NRC inspection reports shall be made available upon request for Board inspection.

Section 15.10. Other Requirements.

All nuclear/radiologic pharmacies shall also adhere to the rules for pharmaceutical care as they pertain to the practice of nuclear pharmacy.

PART 16 NON-RESIDENT PHARMACY

Section 16.1. Definitions.

(a) "Non-resident pharmacy" means a drug outlet or business located outside of Vermont which dispenses prescription drugs or devices for Vermont residents or residents of other states and which mails, ships, or delivers such prescription drugs or devices into this state, or which provides any type of pharmacy services.

(b) "Pharmacy services" as defined in this section includes consulting or medication therapy management. Nonresident pharmacies include pharmacies operating by means of the Internet.

(c) "Medication Therapy Management" as used in this section means a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication or a medical device.

Section 16.2. Licensure.

An applicant for initial licensure must provide to the Board:

(a) evidence that the applicant holds a pharmacy license, registration, or permit issued by the state in which the pharmacy is located that is valid and in good standing;

(b) the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing drugs to residents of this state, including the pharmacist-manager in charge of the non-resident pharmacy license;

(1) If a person: the name, business address, and date of birth;

(2) If a partnership: the name, business address, and date of birth of each partner, and the name of the partnership;

(3) If a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor and the name of the business entity; and

(4) If a corporation: the federal identification number of the corporation, the name, business address, date of birth, and title of each corporate officer and director, the corporate names, the name of the state of incorporation, and the name of the parent company, if any; the name, business address of each shareholder owning five percent or more of the voting stock of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange and not over-the-counter;

(d) affirmation by the sole proprietor, or all partners, or corporate officers and directors, and the pharmacist-manager, that they have not been convicted of, and are not under indictment for, any felony or misdemeanor arising from the violation of any drug or pharmacy related law;

(e) evidence of the applicant's ability to provide to the Board a record of a prescription drug order dispensed by the applicant to a resident of this state not later than 72 hours after a request for the record by the Board;

(f) an affidavit by the pharmacist-manager which states that he or she has read and understands the Vermont laws and rules relating to a non-resident pharmacy;

(g) evidence that during its regular hours of operation, but not fewer than five days per week, for a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records. The toll-free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this state; and evidence that during its regular hours of operation, but not fewer than six days per week, for a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records. The toll-free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this state;

(h) a copy of the most recent inspection report from the state in which the pharmacy is located; and

(i) For internet non-resident pharmacies, a copy of an inspection report not more than three years old by either:

(1) the state in which the pharmacy is located; or

(2) Verified Internet Pharmacy Practice Sites (VIPPS) certification.

Section 16.3. Change of Information.

Changes of information required in Rule 16.2 above shall be submitted to the Board within 30 days.

Section 16.4. Personnel.

A non-resident pharmacy shall be under the continuous on-site supervision of a pharmacist and shall designate one pharmacist licensed to practice pharmacy by the regulatory or licensing agency of the state in which the non-resident pharmacy is located to serve as the pharmacist-manager in charge of the non-resident pharmacy license.

Section 16.5. Prescription Records.

A non-resident pharmacy shall maintain for three years prescription records available for review if required by the Board. Such records shall provide the following information concerning each prescription for a drug or device that is shipped, mailed, or delivered to a resident of Vermont:

(a) the name of the patient;

(b) the name of the prescriber;

(d) the date of the prescription;

(e) the name of the drug;

(f) the strength and quantity of the dose; and

(g) name or other identification of the dispensing pharmacist.

Section 16.6. Substitution of Drug.

A non-resident pharmacy which provides mail order service to a resident of Vermont may substitute a drug as required by the substitution provisions of Title 18 Chapter 91 and as set forth in Rule 10.19 herein.

Section 16.7. Toll-Free Telephone Service.

A non-resident pharmacy that is located outside this state and which provides mail order service to Vermont residents shall provide during its regular hours of operation, but not fewer than six days per week, for a minimum of 40 hours per week, a toll-free telephone service to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records. The toll-free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this state.

Section 16.8. Disciplinary Action.

In addition to any other provisions of law, the Board may initiate disciplinary action when:

(a) a violation of these rules pertaining to non-resident pharmacies is alleged;

(b) a violation affecting a resident of this state is alleged and the state where the non-resident pharmacy is located has taken no action within 45 days from the date the violation was reported;

(c) an emergency arises that would constitute an immediate threat to the health and safety of the residents of this state.

PART 17 WHOLESALE DISTRIBUTORS

Section 17.1. Minimum Required Information for Licensure.

The Board of Pharmacy requires the following from each wholesale distributor as part of the initial licensing procedure and as part of any renewal of such license:

(a) Name, full business address, and telephone number of the licensee;

(b) All trade or business names used by the licensee;

(c) Addresses, telephone numbers, and the names of contact persons for the facility used by the licensee for storage, handling, and distribution of drugs;

(d) Type of ownership or operation (i.e., partnership, corporation, or sole proprietorship); and

(e) Name(s) of the owner and the operator of the licensee, including:

(1) If a person: the name, address, and social security number and date of birth;

(2) If a partnership: the name, address, and social security number and date of birth of each partner, and the name of the partnership;

(3) If a corporation: the federal identification number of the corporation, the name, address, and date of birth, and title of each corporate officer and director, the corporate names, the name of the State of incorporation, and the name of the parent company, if any; the name, and address of each shareholder owning five percent or more of the voting stock of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange and not over-the-counter;

(4) If a sole proprietorship: the full name, address, social security number and date of birth of the sole proprietor, and the name of the business entity.

(5) Affirmation by the sole proprietor, or all partners, or corporate officers and directors, and the pharmacist-manager, that they have not been convicted of, and are not under indictment or under investigation for, any felony or misdemeanor arising from the violation of any drug or pharmacy related law.

Section 17.2. Required Forms.

The information required for initial licensure or renewal of a license of a wholesale distributor shall be submitted on forms prepared by the Board, and shall be submitted to the Board accompanied by the applicable fee as directed on such form.

Section 17.3. Change of Information.

Changes of information required in Rule 17.1 above shall be submitted to the Board within 30 days.

Section 17.4. Acts Which May Affect Licensure.

Among the factors the Board of Pharmacy will consider when deciding whether to grant a license to a wholesale distributor are:

(a) Any conviction of the applicant under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state, or local laws;

(c) The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(e) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drug, including controlled substances;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with the requirements to maintain or make available to the Board or to federal, state, or local law enforcement officials those records required to be maintained or made available by wholesale drug distributors;

(h) Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety. Section 17.5. Personnel.

The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

Section 17.6. Minimum Requirements for the Storage and Handling of Drugs.

All facilities at which drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(a) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) have storage areas big enough to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c) have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened; and

(d) be maintained in a clean and orderly condition.

Section 17.7. Security.

All facilities used for wholesale drug distribution shall be secure from unauthorized entry.

(a) Access from outside the premises shall be kept to a minimum and be well-controlled.

(b) The outside perimeter of the premises shall be well-lighted.

(d) All facilities shall be equipped with an alarm system to detect entry after hours.

Section 17.8. Diversion Prevention.

All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

Section 17.9. Storage.

All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium.

(a) If no storage requirements are established for a drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of drugs.

Section 17.10. Inspections.

All wholesalers must submit proof with initial and renewal applications that they have successfully passed and have maintained a current inspection (not more than three years old) certification by the Pharmacy Board in the state in which they reside, or have successfully obtained and maintained VAWD certification, or from inspection certification from another similar body approved by the Board.

Section 17.11. Examination of Materials.

Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated drugs, or drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

Section 17.12. Examination of Outgoing Shipments.

Each outgoing shipment shall be carefully inspected for identity of the drug products and to ensure that there is no delivery of drugs that have been damaged in storage or held under improper conditions.

Section 17.13. Returned, Damaged, and Outdated Drugs.

Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

Section 17.14. Compromised Packaging.

Any drug whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other drugs until they are either destroyed or returned to the supplier.

Section 17.15. Drug Safety/Quality Questions.

(a) If the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity.

(b) In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

Section 17.16. Record Keeping.

(a) Wholesale distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. This includes:

(1) stored drugs;

(2) all incoming and outgoing drugs; and

(3) all outdated, damaged, deteriorated, misbranded, or adulterated drugs.

(b) These records shall include the following information:

(1) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

(2) The identity and quantity of the drugs received and distributed or disposed of; and

(3) The dates of receipt and distribution or other disposition of the drugs.

Section 17.17. Availability of Records.

Inventories and records shall be made available for inspection and photocopying by any authorized official of any governmental agency charged with enforcement of these rules for a period of two years following disposition of the drugs.

Section 17.18. Record Retention.

(a) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.

(b) Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by an authorized official of any governmental agency charged with enforcement of these rules.

Section 17.19. Reporting Thefts.

Any theft or significant loss of prescription drugs shall be reported to the Board within 5 days. The report should be made on forms available from the Board for this purpose.

Section 17.20. Written Policies and Procedures.

Wholesale distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

Section 17.21. Written Policies, Contents.

Wholesale distributors shall include in their written policies and procedures the following:

(a) A procedure whereby the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.

(b) A procedure to be followed for handling recalls and withdrawals of drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

(1) any action initiated at the request of the Food and Drug Administration or other federal, state, or local law enforcement or other government agency, including the Board of Pharmacy;

(2) any volunteer action by the Manufacturer to remove defective or potentially defective drugs from the market; or

(3) any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.

(4) A procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of a strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(5) A procedure to ensure that any outdated drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed.

(A) This procedure shall provide for written documentation of the disposition of outdated drugs.

(B) This documentation shall be maintained for two years after disposition of the outdated drugs.

Section 17.22. Responsible Individuals.

Wholesale distributors shall establish and maintain lists of officers, directors, managers, and other individuals in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

Section 17.23. Compliance with Federal, State, and Local Laws.

Wholesale distributors shall operate in compliance with applicable federal, state, and local laws and rules.

Section 17.24. Inspections Authorized.

Wholesale distributors shall permit the Board of Pharmacy and authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures at reasonable times and in a reasonable manner to the extent authorized by law.

Section 17.25. Controlled Substances Compliance Requirements.

Wholesale distributors that deal in controlled substances shall register with the Drug Enforcement Administration (DEA), and shall comply with all applicable state, local, and DEA requirements.

Section 17.26. Salvaging and Reprocessing.

Wholesale distributors shall be subject to the provisions of any applicable federal, state, or local laws or rules that relate to drug product salvaging or reprocessing, including Title 21, parts 207, 210, and 211 subpart K of the Code of Federal Regulations.

PART 18 COMMUNITY BASED LONG TERM CARE PHARMACIES

Section 18.1. Community Based Long Term Care Pharmacies.

Community based long term care pharmacies are those pharmacies that are closed to retail trade and only provide services to patients who may or may not reside in institutional settings, but who require a higher level of service than that typically provided by retail pharmacies. These would include unit dose or multi dose packaging promoting compliance with drug treatment regimens, and higher levels of medication therapy management.

Section 18.2. Applicable Rules.

Community Based Long Term Care Pharmacies shall comply with Part 9 herein, Pharmacy Practice Rules.

Section 18.3. Community Based Long Term Care Pharmacies versus Institutional Long Term Care Pharmacies.

Community based long term care pharmacies are distinguished from Institutional Long Term Care Pharmacies which are addressed in 10.2(b) of these Rules.

PART 19 REMOTE PHARMACIES

Section 19.1. General Purpose.

(a) This Part is enacted pursuant to 26 V.S.A. § 2032 which in 2006 initially authorized the Board of Pharmacy to conduct pilot remote pharmacy experiments and to then propose rules governing remote pharmacy and remote pharmacy practice.

(b) The Board's experiment shows that residents of identified under-served areas of Vermont can benefit from having access to remote pharmacies. Vermonters in under-served areas are significantly restricted in their ability to obtain needed prescription drugs. Remote pharmacies enable Vermonters to obtain prescription drugs in their own communities while still being able to consult with a pharmacist in a manner where public health, safety and welfare can be assured.

(c) Remote pharmacies should be located only in those areas where residents require basic pharmacy services and do not have a reasonably accessible retail pharmacy nearby. Remote pharmacies are designed to allow patients to, as closely as possible, receive the basic care, attention, and services that they would expect from a traditional retail pharmacy. Because a pharmacist is not required to be on the premises at all times however, the remote pharmacy cannot provide the full range of services normally provided by a retail pharmacy.

(d) Remote pharmacies are not intended to be a substitute for retail pharmacies where a pharmacist is present whenever prescription drugs are dispensed.

Section 19.2. Definitions.

(a) "Certified pharmacy technician" means an individual who is:

(1) registered with the Board as a pharmacy technician;

(2) whose registration is unencumbered;

(3) who has obtained and maintains current certification from a national technician certification authority approved by the Board; and

(4) who has a minimum of 2,000 hours experience as a registered pharmacy technician.

(b) "Coordinating pharmacist" means a Vermont licensed pharmacist with an unencumbered license who provides remote pharmacy services and who has no less than three years licensed practice experience.

(c) "Coordinating pharmacist manager" means a Vermont licensed pharmacist who has full responsibility for all aspects of one or more remote pharmacies.

(d) "Coordinating pharmacy" as used in this Part means a licensed pharmacy located within the State of Vermont or a Vermont licensed pharmacist not affiliated with a pharmacy. The "coordinating pharmacy," as permitted by the Board, provides remote pharmacy services at one or more licensed remote dispensing/pharmacy sites.

(e) "Remote pharmacy" means a licensed pharmacy facility where pharmacy services are provided by a coordinating pharmacist. The remote pharmacy is designed so that a pharmacist at a different location provides pharmacy services electronically via a computer system and via video and audio communication system approved by the Board.

(f) "Remote pharmacy practice" means the provision of pharmaceutical care services, including the storage and dispensing of prescription drugs, drug regimen review, and patient counseling, at a staffed remote dispensing site.

Section 19.3. Coordinating Pharmacist Manager.

(a) The Coordinating pharmacist manager is a Vermont licensed pharmacist who:

1) has no less than three years licensed practice experience;

2) possesses an unencumbered license; and

3) has been specifically designated and registered with the Board to serve as a coordinating pharmacist manager.

(b) When the remote pharmacy is affiliated with a Vermont retail pharmacy, the retail pharmacy's pharmacist manager shall be the coordinating pharmacist manager.

Section 19.4. Coordinating Pharmacist Manager Responsibilities.

The coordinating pharmacist manager shall be responsible for, at a minimum, the following:

(a) Submitting for Board approval the operational plan for the remote pharmacy service, including:

(1) justification of the need for the remote pharmacy service as provided in this Part.

(2) identification of the coordinating site;

(3) identification of the remote dispensing site;

(4) the names and titles of key personnel at both locations;

(5) the quality assurance and improvement plan;

(6) a policies and procedure manual; and

(7) explanation of the remote dispensing process to be utilized at the remote dispensing site;

(b) Ensuring that the practice of pharmacy performed at the remote pharmacy and the supervision of pharmacy technicians complies with applicable federal and state statutes and regulations and these rules;

(1) any automated pharmacy system is in good working order;

(2) the AMDS accurately dispenses the correct strength, dosage form, and quantity of the prescribed drug and accurately prints the prescription label while maintaining appropriate record-keeping, security, and quality assurance safeguards;

(d) Ensuring that all pharmacists and pharmacy technicians authorized to provide remote pharmacy services at the managing pharmacy or the remote site:

(1) maintain current licensure or registration with the Board;

(2) are trained in the operation of any automated pharmacy system; and

(3) are familiar with policies and procedures relating to the remote pharmacy practice.

Section 19.5. Change of Coordinating Pharmacist Manager.

A change in the coordinating pharmacist manager shall be reported in the manner a change of a pharmacist manager is reported under Part 6 of these Rules.

Section 19.6. Coordinating Pharmacist Duties.

Only the coordinating pharmacist may perform the activities listed in this rule. These activities may not be delegated to a pharmacy technician at a remote site.

(a) Receiving an oral prescription drug order from a prescriber or the prescriber's agent for dispensing to a patient at the remote site;

(b) Interpreting a prescription drug order;

(d) Interpreting the patient's drug record and conducting a drug utilization review;

(e) Authorizing any AMDS to dispense a prescription drug and print a prescription label at the remote site;

(f) Performing the final verification of a dispensed prescription;

(g) Counseling the patient or the patient's care-giver; and

(h) Completing and documenting the weekly inspection of the remote site.

Section 19.7. License Required for Remote Pharmacy Services - General Requirements.

(a) To be eligible for a remote pharmacy license, the applicant shall comply with the application process set forth in Rules 7.2 and Rule 7.3 herein and demonstrate to the Board that there is limited access to pharmacy services in the community where the remote site is proposed.

(b) In determining whether a community has limited access to pharmacy services, the Board may consider, but is not limited to the following factors:

(1) the proximity of a licensed retail or remote pharmacy;

(2) the geographical location of the community and proximity or ease of access to a retail pharmacy; and

(3) the nature of the community and its demographics.

(c) In no event will the Board approve a remote pharmacy if a retail pharmacy is located within a ten (10) mile drive by motor vehicle.

(d) Notwithstanding subsection (c) above, a remote pharmacy approved by the Board as part of the pilot project before adoption of these rules may, so long as it remains in compliance with these rules, continue to operate at its present locations.

Section 19.8. Laws Applying to Remote Pharmacies.

(a) Each remote pharmacy shall, in addition to meeting the requirements of these rules, comply with all applicable federal and state laws.

(b) If controlled substances are dispensed from the remote pharmacy, the remote pharmacy must obtain its own DEA registration.

(c) Where remote pharmacy rules conflict with the other rules governing retail pharmacies, the requirements of this Part shall apply. Space requirements for retail pharmacies do not apply to remote pharmacies.

Section 19.9. Policy and Procedure Manual.

The coordinating pharmacy and remote pharmacy shall operate pursuant to a written policy and procedure manual that is established by the coordinating pharmacy. The policy and procedure manual shall include, but is not limited to the following:

(a) a current list containing the name and business address of the coordinating pharmacist and personnel designated by the coordinating pharmacist manager to have access to the area where drugs are stored at the remote pharmacy;

(b) duties that may only be performed by a pharmacist; and

(1) operation of the video/auditory communication system;

(2) security;

(3) sanitation;

(4) storage of drugs;

(5) dispensing;

(6) supervision; and

(7) drug procurement, receipt of drugs, and delivery of drugs.

Section 19.10. Record Keeping.

The coordinating pharmacist manager shall, at least annually, review and revise as necessary the written policies and procedures, and document such review.

Section 19.11. Remote Pharmacy Staffing.

(a) A pharmacist, pharmacy technician, or pharmacy intern performing services in support of a remote pharmacy, whether those services are performed at the coordinating pharmacy or the remote pharmacy, must be licensed by or registered with the Board.

(b) Remote pharmacies shall be staffed by certified pharmacy technicians under the continuous supervision of a Pharmacist. A remote pharmacy where the sole operation is limited to an AMDS dispensing pre-packaged medications in a secure dispensing unit may be staffed by a certified pharmacy technician, licensed practical nurse, registered nurse, or authorized prescriber any of whom shall register as a pharmacy technician with the Board and shall be under the continuous supervision of a Pharmacist.

(d) A pharmacist who is engaged in the operation of a retail, institutional, or mail order pharmacy shall not simultaneously operate more than one remote pharmacy.

(e) A coordinating pharmacist who is also engaged in retail or institutional pharmacy may supervise the interpretation, evaluation, and implementation of a prescription drug order, including the preparation of a drug or device to a patient or patient's agent, to an average of 125 prescriptions at the remote pharmacy per work day in any one week or a peak of 150 prescriptions on any one day. This supervision limit does not apply to central filled or refill prescriptions dispensed at the remote pharmacy.

(f) A pharmacist who is not engaged in the operation of a retail, institutional or mail order pharmacy may operate no more than three simultaneously open Remote Pharmacies. A coordinating pharmacist providing only remote pharmacy services may supervise the interpretation, evaluation, and implementation of a prescription drug order, including the preparation of a drug or device to a patient or patient's bona fide representatives to an average of 250 prescriptions per work day in any one week or a peak of 300 prescriptions per day.

(g) A coordinating pharmacy providing remote pharmacy services shall provide sufficient staffing to meet the prescription work load. In an emergency, a temporary exception to this limit may, in the Board's discretion, be granted where the Coordinating Pharmacy has documented a need to supervise additional remote pharmacies and has demonstrated that appropriate safeguards are in place to ensure proper supervision of each.

Section 19.12. Notices and Displays.

(a) Each remote pharmacy shall have a notice clearly visible to the public stating: "This is a licensed remote pharmacy. A pharmacist may not be physically present. A pharmacist from the pharmacy in reviews every prescription dispensed here. Whether physically present here or at the pharmacy, the pharmacist is required to speak with you before your prescription will be dispensed."

(b) The license, or a copy thereof, of any pharmacist providing remote pharmacy services must be prominently displayed at the remote pharmacy.

(c) The registration and national certification, or copy thereof, of any pharmacy technician at a remote pharmacy shall be prominently displayed.

(d) Remote pharmacies must display all signs required by state or federal law for any retail pharmacy.

Section 19.13. Storage Security.

Drugs stored at Remote pharmacy shall be stored in an area that is:

(a) separate from any other drugs at a health care facility; and

(b) locked by key or combination, so as to prevent access by unauthorized personnel.

(c) Access to the area where drugs are stored at the remote pharmacy must be limited to registered or licensed pharmacy personnel.

Section 19.14. Audiovisual Link.

(a) There must be a continuously accessible, two-way audiovisual link between the coordinating pharmacist and the remote pharmacy. The transmission of information through the computer link must make information available to the coordinating pharmacist and the remote pharmacy simultaneously. The video camera used for the certification of prescriptions must be of sufficient quality and resolution so that the coordinating pharmacist can visually identify the markings on tablets and capsules. No prescription may be dispensed if the audio/visual link is not fully operational.

(b) Audio/video and IT communications disruptions shall be documented and retained for three years.

(c) The audio/visual link shall be recorded while the remote pharmacy is in operation. The recording shall be retained for 30 days.

(d) Each remote pharmacy shall have security cameras which shall capture movement within the remote pharmacy at all times. The coordinating pharmacist shall be able to monitor the security cameras at all times.

Section 19.15. AMDS Requirements.

An AMDS used in a remote pharmacy must comply with AMDS provisions contained in Part 11 of these rules.

Section 19.16. Remote Pharmacy Operation.

(a) A remote pharmacy may utilize an AMDS located in an area accessible only to registered or licensed pharmacy personnel.

(b) The coordinating pharmacist shall have access to the remote pharmacy's automated data processing system to perform a prospective drug utilization review (DUR) prior to dispensing. The pharmacist shall ensure, through the use of the video/auditory communication system, that the certified pharmacy technician has accurately and correctly prepared the drug for dispensing according to the prescription drug order.

(c) The remote pharmacy may be open only if the computer link, video link, and audio link with the coordinating pharmacy are functioning properly. If any link is not functioning properly, the remote pharmacy must be closed unless a pharmacist is working at the remote pharmacy.

(d) Any prescription filled at the remote pharmacy must be reviewed and interpreted by a pharmacist before the prescription is dispensed.

(e) A remotely dispensed prescription must have a properly prepared label attached to the final drug container before the pharmacist approves the prescription for dispensing.

(f) The computer must be capable of carrying the initials of the technician preparing the prescription and the pharmacist verifying the prescription.

(g) No compounding may occur at a remote pharmacy unless a pharmacist is physically present.

Section 19.17. Written or Electronic Prescription Drug Orders.

(a) A remote dispensing site may receive only written, faxed, or electronic prescription drug orders. The pharmacy technician at the remote site shall either transmit the prescription drug order or refill request to the coordinating pharmacy. The pharmacy technician may input the prescription drug order or refill request so that coordinating pharmacist may perform a prospective drug utilization review and verify the prescription information prior to authorizing dispensing from the remote site.

(b) A pharmacy technician at a remote pharmacy shall not receive oral prescription drug orders from a practitioner or practitioner's agent. Oral prescription drug orders shall be communicated directly to a coordinating pharmacist.

Section 19.18. Schedule II Prescriptions.

Schedule II prescriptions shall be dispensed as follows:

(a) patient presents original hard copy of Schedule II prescription to the remote pharmacy; (faxed prescriptions are not permitted)

(b) after verifying that the prescribed drug is in stock, technician dates, cancels, and signs the original hard copy;

(d) the coordinating pharmacist prints and reviews scanned prescription;

(e) the coordinating pharmacist dates, cancels, and signs the printed scanned prescription;

(f) the coordinating pharmacist re-scans the prescription to the patient file;

(g) the technician at the remote site prints the pharmacist's cancelled prescription and attaches it to the original prescription.

(h) No less than once per week, the original prescription must be reviewed in person by a pharmacist who then cancels, signs, and dates the original prescription.

Section 19.19. Counseling.

Unless the patient affirmatively refuses counseling, which refusal shall be documented, counseling is required for all new prescriptions.

Section 19.20. No Returned Drugs.

A remote pharmacy may not receive "take backs" except drugs returned due to a prescription dispensing error made at that site.

Section 19.21. Inspections and Board of Pharmacy Access to Records.

(a) All policies and procedures for any remote pharmacy must be maintained both in the coordinating pharmacy and the remote pharmacy and be available for inspection by the Board. The Board may physically inspect a remote pharmacy as it deems appropriate.

Section 19.22. Quality Assurance.

The coordinating pharmacist manager must:

(a) conduct an inspection of the remote pharmacy at weekly intervals or more frequently if necessary. Inspection must be documented and kept on file at the remote pharmacy and available upon request by the Board;

(b) implement and conduct a quality assurance plan that provides for on-going review of dispensing errors, with appropriate action taken, if necessary, to assure patient safety;

(d) Maintain records of all controlled substances stocked by the remote pharmacy through a daily perpetual inventory. Controlled substance perpetual inventory records must be available for Board inspection;

(e) conduct an inventory of all controlled substances at least monthly to verify accuracy; and

(f) maintain a record of medication errors.

Section 19.23. Reports to the Board.

(a) Initial Report After 180 days of operation the coordinating pharmacist manager for each remote pharmacy shall submit a report to the Board. The report shall:

(1) summarize identified errors by category and shall include the total number of errors identified, the reasons for the errors, the corrective actions taken to prevent the recurrence of those errors.

(2) state the number of prescriptions dispensed each month.

(b) Subsequent reports, annually. Within 15 days of the anniversary of the opening date, the coordinating pharmacist manager for each remote pharmacy shall submit a report to the Board. The report shall contain all the information required in subsection (a) of this rule.

Section 19.24. Renewal Requirements.

(a) Before a remote pharmacy license will be renewed, the licensee must demonstrate a continuing need for the remote pharmacy addressing the criteria upon which the initial license was granted. The Board's renewal form may contain questions to assist the renewal evaluation process so that the Board can determine whether there is a continuing need for the remote pharmacy.

(b) Remote renewals applications must be submitted using forms approved by the board.

(c) The Board will not renew a remote pharmacy license if a retail pharmacy is granted a license to operate within ten (10) miles by motor vehicle of the remote pharmacy's location. The remote pharmacy may apply to the Board for a pharmacy license for that location.

Section 19.25. Remote Pharmacy Closing.

A remote pharmacy which is to close shall comply with the drug outlet closing provisions of these Rules.

PART 20 UNPROFESSIONAL CONDUCT AND DISCIPLINARY INFORMATION

Section 20.1. Definitions.

The Board may take disciplinary action against a licensee, former licensee, or applicant for any of the grounds of unprofessional conduct set forth in 26 V.S.A. § 2051 or in 3 V.S.A. § 129a. 3 V.S.A. § 129a(a)(3) includes within the definition of unprofessional conduct, "(3) ailing to comply with provisions of federal or state statutes or rules governing the practice of the profession." Unprofessional conduct includes:

(a) Giving or receiving improper assistance in connection with any part of the examinations for licensure.

(b) Failing to provide, or false documentation of, continuing pharmacy education.

(d) Participating in, or agreeing to, activities whereby prescription orders, or prescription drugs and devices may be regularly delivered, or received, or solicited, or accepted by or to any non-licensed person.

(e) Providing prescription pads or blanks inscribed with the pharmacist's name, or the name and address of the drug outlet, for office use by a prescriber.

(f) Any disciplinary action in any jurisdiction by a licensing authority regulating the practice of a health-related profession.

(g) Dealing with drugs or devices that the licensee knows or should know are stolen drugs or devices or that the licensee knows or should know were obtained through distribution channels that do not comply with licensing requirements.

(h) Attempting to circumvent the patient counseling requirements, or discouraging the patient from receiving patient counseling concerning his or her prescription drug order.

(i) Divulging or revealing to unauthorized persons patient or practitioner information or the nature of professional pharmacy services rendered without the patient's express consent, or without order or direction of a court. The following are considered authorized persons:

(1) Patient or patient's agent, or another pharmacist acting on behalf of a patient;

(2) Practitioner who issued the prescription drug order;

(3) Certified or licensed health care personnel who are responsible for the care of the patient;

(4) A member, inspector, agent, or investigator of the Board or any federal, state, county, or municipal officer whose duty is to enforce the laws of this State or the United States relating to drugs or devices or both and who is engaged in a specific investigation involving a designated person or drug; and

(5) An agency of government charged with the responsibility of providing medical care for the patient, upon a written request by an authorized representative of the agency requesting such information.

(j) Selling, giving away, or otherwise disposing of accessories, chemicals, or drugs or devices found in illegal drug traffic when the pharmacist knows or should have known of their intended use in illegal activities.

(k) Selling a drug for which a prescription drug order from a practitioner is required, without having received a prescription drug order for the drug.

(l) Willfully and knowingly failing to maintain complete and accurate records of all drugs received, dispensed, or disposed or in compliance with the federal laws and regulations and state laws and rules.

(m) Obtaining any remuneration by fraud, misrepresentation, or deception, including but not limited to, receiving remuneration for amending or modifying, or attempting to amend or modify, a patient's pharmaceutical care, absent a clear benefit to the patient, solely in response to promotion or marketing activities.

Section 20.2. Independent Judgment.

3 V.S.A. § 129a(b) requires practitioners to practice competently. This includes conforming to essential standards of acceptable and prevailing practice. Part of a pharmacist's responsibilities is the duty to use independent professional judgment.

(a) A licensed pharmacist must comply with federal and state statutes and rules including the rules of the Vermont Board of Pharmacy. The nature of contemporary pharmacy practice may from time to time place a pharmacist in a position where adherence to legal requirements may conflict with the expectation of prescribers, employers or others.

(b) When such conflicts arise, the pharmacist's obligation is to exercise independent professional judgment. This may require a pharmacist to tell patients, prescribers, employers or others that his or her legal obligations prevent him or her from taking a certain course of action or complying with the wishes of others.

Section 20.3. Initiating a Complaint.

Anyone wishing to make a complaint of unprofessional conduct against a licensed professional should file a written complaint with the Office of the Secretary of State, Office of Professional Regulation, 89 Main St., Fl. 3, Montpelier, VT 05620-3402. The telephone number is (802) 828-1505. A complaint form may also be accessed from the Office Web site http://www.vtprofessionals.org.

Section 20.4. Investigations.

The Board may receive complaints from any source. 3 V.S.A. § 129(b).

Section 20.5. Disciplinary Process.

The Board follows the current complaint procedure recommended by the Office of Professional Regulation. A copy of the procedure and more information about the complaint process can be obtained from the Office.

Section 20.6. Confidentiality.

Confidentiality of disciplinary matters is governed by 3 V.S.A. § 131.

Section 20.7. Appeals.

Appeals from Board decisions are governed by 3 V.S.A. § 130.

Section 20.8. Reinstatement after Revocation.

(a) Unless the Board orders otherwise in a disciplinary decision, a licensee whose license has been revoked may apply for reinstatement at any time after one year has elapsed from the effective date of the revocation, or the date of the last application for reinstatement, if more than one application has been made.

(b) An application for reinstatement must show, among other requirements, that the licensee is fully rehabilitated from the conduct which produced the revocation, and should include supporting recommendations from pharmacists who have personal knowledge of the applicant's activities since the revocation. Information about other requirements and necessary documentation may be obtained from the Director of the Office of Professional Regulation.

Section 20.9. Modification of Orders.

(a) A licensee whose license has been suspended, restricted, or placed under supervision may apply for modification of the Board's order at any time after six months have elapsed from the effective date of the order, or the date of the last application, if more than one application has been made, unless an order of the Board provides otherwise.

(b) An application for reinstatement of an unrestricted license must show, among other requirements, that the licensee is fully rehabilitated from the conduct which produced the disciplinary action, and should include supporting recommendations from pharmacists or other relevant persons who have personal knowledge of the applicant's activities since the action. Information about other requirements and necessary documentation may be obtained from the Director of the Office of Professional Regulation.

Notes

04-230 Code Vt. R. 04-030-230-X

EFFECTIVE DATE:
December 25, 1992 Secretary of State Rule Log #92-65; September 15, 2015
AMENDED:
September 1998; August 15, 2003 Secretary of State Rule Log #03-28; October 1, 2009 Secretary of State Rule Log #09-029; June 1, 2014 Secretary of State Rule Log #14-017 (cite as B.O.P. Rule x.x.); September 15, 2015 Secretary of State Rule Log #15-038; December 2015; October 2018 [correction to Section 10.23]

STATUTORY AUTHORITY:

26 V.S.A. §§ 2032, 2042b, 2061, 2062, 2063

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