070.00.06 Ark. Code R. § 002 - Regulation 04 - General Regulations Regarding Pharmacies
Minimum prescription equipment specifications as authorized by the Arkansas State Board of Pharmacy are:
EXCEPTIONS: Pharmacies meeting the requirements of regulation 04-02-0100 or regulation 07-02-0001 shall be exempt from requirements of this regulation when not applicable. (10/09/80, Revised 6/25/83, 4/07/89, 6/07/90, and 8/20/97)
The sale of any legend drugs or medicines by means of a coin-operated vending machine is expressly prohibited. (10/09/80)
The reuse of returned portions of a prescription drug for human consumption is prohibited whether dispensed by order of a prescription or otherwise, except to allow patients in nursing facilities to donate unused medications to charitable clinic pharmacies as provided by Ark. Code Ann. § 17-92-1101 et seq. and Board Regulations 04-03-0004 and 04-07-0006. (10/9/80, Revised 6/23/05)
No person, firm, or business establishment shall offer to the public, in any manner, their services as a "pick-up-station" or intermediary for the purpose of having prescriptions filled or delivered, whether for profit or gratuitously. Nor may the owner of any pharmacy or drug store authorize any person, firm, or business establishment to act for them in this manner-provided however, intermediary delivery stations after approval by the Board may be operated in clinics in which a practitioner is in attendance at least one day per week and located in an area where pharmaceutical services are unavailable within ten miles of the clinic provided the filled prescriptions are delivered to a designated representative of the pharmacist filling the prescription. (10/09/80, Amended 2/17/82, and 8/19/99)
Any pharmacy providing prescription drugs to one or more patients in a nursing home or other institution shall provide emergency prescription services for those patients and shall provide information to the nursing home or institution indicating how the pharmacists can be reached after pharmacy hours.
All pharmacies (other than hospital and institutional) who do not provide emergency drug services for non-institutionalized patients shall post a sign at least 8/4 by 11" with letters of at least one (1) inch stating "This pharmacy will not provide emergency prescription drugs when the pharmacy is closed." (6/25/83)
Any person, corporation or partnership operating a pharmacy in this state desiring to continue such operation must pay a renewal fee for the permit as established by law and/or regulation. If the fee is not paid on or before February 1st of any even-numbered year, a penalty as defined in regulation 01-00-0007 shall be levied for each month the pharmacy permit fee is delinquent. If the permit fee is unpaid by April 1st of any even-numbered year, the licensed pharmacy shall be expunged from the records of the State Board of Pharmacy, and the owner and/or pharmacist in charge thereof shall, within thirty days, remove all drug signs and legally dispose of all prescription legend drugs. (10/9/80, amended 6/13/85, amended 6/20/91 & 8/23/96)
Pharmacies shall apply for licensure and renewal on forms provided by the Board. The permit will be issued to qualified applicants in the name of the licensed pharmacist who shall be directly responsible to the Board of Pharmacy for the operation of the prescription department. (Revised 11/15/2003)
Applications for pharmacy permits, other than annual renewal of existing permits, will be reviewed by the Board of Pharmacy Staff. No pharmacy may open for business within thirty (30) days of submission of the original application. Applications for a pharmacy permit for a new pharmacy must have the name and license number of the pharmacist in charge at the time of submission and cannot be altered except by submission of an application for change of pharmacist in charge and the fee as defined in regulation 01-00-0007. The pharmacist in charge of the new pharmacy application cannot be the pharmacist in charge of another pharmacy at the time of submission of the new pharmacy application. If a post office box is used as the address for the pharmacy, the actual street address must also be included on the application. The Executive Director may require that a representative of the owner(s) and the pharmacist in charge appear before the Board of Pharmacy to finalize the application. After review by the Board of Pharmacy staff, an "Inspection Request Form" will be sent to the mailing address of the pharmacy making application. The inspection request form must be received in the Board of Pharmacy office at least one week before the facility will be ready for inspection.
Upon approval of the inspection of the physical facility by the Board of Pharmacy inspector, the Executive Director will complete the final approval of the application and the permit number will be issued.
No pharmacy permit shall be issued or continued for the conduct of a pharmacy unless the premises are equipped with the necessary appliances for maintenance of proper sanitation and kept in a clean, sanitary and orderly manner.
A pharmacist in charge of a retail pharmacy may act as a consultant or part-time pharmacist.
The permit licenses the pharmacy to which it is issued and is not transferable. It is issued on the application of the owner and the licensed pharmacist in charge, on the sworn statement that it will be conducted in accordance with the provisions of law.
The responsibility to ensure compliance with this regulation rests both with the pharmacist and with the pharmacy owner if they are not the same. (10/09/80, Revised 2/17/82, 6/13/85, 2/10/87, 4/07/89, 6/20/91, and 6/23/96)
No owner or owners of a drugstore, apothecary, pharmacy, etc., should allow any of its employees to profess to the public in any manner that they are a licensed pharmacist when they are not licensed. (10/9/80, amended (6/20/91).
A retail pharmacy with a licensed pharmacy permit may also act as a central fill pharmacy if the following requirements are met.
The central fill pharmacy shall:
A policy and procedure manual as it relates to centralized filling shall be maintained at the filling, originating, and dispensing pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:
(11/15/2003, Revised 3/14/2006)
The practice of nuclear pharmacy is hereby recognized as a specialty of pharmacy practice regulated by the Arkansas State Board of Pharmacy. As such, the following rules are included to address those areas specific, or unique to, this specialty practice. These regulations are intended to supplement the regulations of other state and federal agencies.
Orders for routine diagnostic radiopharmaceuticals, which have been previously established by the nuclear pharmacist with the physician, may be taken by a pharmacy technician and entered into the computer. The nuclear pharmacist shall verify the label with the written order. However, whenever an order is for a therapeutic or blood-product radiopharmaceutical, the prescription order must be received by a nuclear pharmacist and the patient's name must be obtained and recorded prior to dispensing.
When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label prior to dispensing.
The professional area of the pharmacy shall have the following equipment:
The Board may issue a specialty pharmacy permit for a facility to provide unique aspects of pharmaceutical care to an identified patient population as provided in regulation 04-03-0001 et seq. Said specialty pharmacies and the pharmacists practicing therein shall comply with applicable federal and state laws and regulations, including Arkansas Pharmacy Law, A.C.A. § 17-92-101 et seq., and Board Regulations, including without limitation regulations regarding retail pharmacies 04-02-0001et seq., which are not expressly superseded by the regulation applicable to the specific type of specialty pharmacy.
The pharmacy shall be locked when a pharmacist is not present in the pharmacy and shall have adequate facilities for performing pharmaceutical services including the procurement, storage, distribution, security and control of said drugs consistent with all federal and state laws and regulations.
The pharmacist in charge shall obtain approval by the Board's Executive Director prior to any change in any item identified in subparagraph (b) (1) (B) (i) - (vii) of this regulation. (6/23/05)
Out of State pharmacies shall comply with the following qualifications to be, and remain, licensed in Arkansas by the Board.
Provided, however, the Board may grant an exemption from licensing under A.CA. § 17-92-401 upon application by any non-resident pharmacy which confines its dispensing activity to isolated transactions. In determining whether to grant an exemption, the Board shall consider:
Nothing herein shall be construed to mandate that an out of state pharmacy comply with Board regulation 09-00-0001 if such compliance would cause the out of state pharmacy to violate law or regulation of the state wherein the facility of the dispensing out of state pharmacy is located.
The responsibility to ensure compliance with this regulation rests both with the Arkansas pharmacist in charge and with the pharmacy owner if they are not the same. (10/09/90, Revised 04/10/92, 6/23/96, 8/23/96,10/12/99, 11/15/2003, and 7/16/2006).
All hospitals shall have adequate provisions for pharmaceutical services regarding the procurement, storage, distribution, and control of all medications. All federal and state regulations shall be complied with.
"Hospital pharmacy" shall also mean the place or places in which drugs, chemicals, medicines, prescriptions or poisons are compounded for the dispensing to hospital employees, members of the immediate families of hospital employees, patients being discharged, and other persons in emergency situations.
"Hospital pharmacy" shall also mean the provision of pharmaceutical services as defined in the Pharmacy Practice Act by a pharmacist to a patient of the hospital.
"Unit dose distribution system" also means a system that meets the requirement of a "Unit Dose Distribution System," provided that up to a 72-hour supply may be sent to the floor once a week if the system has been reviewed and approved administratively by the Board of Pharmacy.
An act, restricted to nursing personnel as defined in Nurses Practice Act 43 of 1971, in which a single dose of a prescribed drug or biological is given a patient. This activity includes the removal of the dose from a previously dispensed, properly labeled container, verifying it with the prescriber's orders, giving the individual dose to the proper patient and recording the time and dose given.
There is a committee of the medical staff to confer with the pharmacist in the formulation of policies, explained as follows:
The hospital has a pharmacy directed by a licensed pharmacist. The pharmacy is administered in accordance with accepted professional principles.
There is a pharmacy directed by a licensed pharmacist, defined as follows:
Facilities are provided for the storage, safeguarding, preparation, and dispensing of drugs, defined as follows:
Personnel competent in their respective duties are provided in keeping with size and activity of the department, explained as follows:
Through the administrator of the hospital, the P & T Committee shall establish policies and procedures that include, but are not limited to the following:
Records are kept of the transactions of the pharmacy and correlated with other hospital records where indicated. All medication shall be properly labeled. Such record and labeling requirements are as follows:
Policies are established to control the administration of toxic or dangerous drugs with specific reference to the duration of the order and the dosage, explained as follows:
Therapeutic ingredients of medications dispensed are included (or approved for inclusion) in the United States Pharmacopoeia, N.F. and U.S. Homeopathic Pharmacopoeia, or Accepted Dental Remedies (except for any drugs unfavorably evaluated therein) and drugs approved by provisions of the Arkansas Act 436 of 1975, or are approved for use by the P & T Committee of the hospital staff, explained as follows:
Any take-home prescription dispensed to patients at time of discharge from the hospital shall be for drugs and quantities consistent with the immediate medical needs of the patient.
The minimum requirements for licensed pharmacists in hospitals are:
At no time will the hospital pharmacy be open and in operation unless a licensed pharmacist is physically present except:
The American Society of Health-System Pharmacists' most recent statement on hospital drug control systems and Guidelines for Institutional Use of Controlled Substances shall be required reading by hospital pharmacists. (Revised 6/25/83,4/7/89, 6/15/95, and 8/2001)
Hospitals using mechanical storage and delivery machines for legend drags must secure a hospital pharmaceutical services permit, and these machines shall be stocked only by a licensed pharmacist under this permit. Drugs may be obtained from these machines only by a physician, or registered or licensed professional nurse or student nurse, or an intern or resident physician, or a licensed pharmacist acting under the prescribed rules of safety procedures as promulgated by the individual hospital or institution using the machine. Use of these machines shall not be to circumvent adequate pharmaceutical services. (Amended 8/23/96)
The Patient Daily Medication Record is a document, whether electronic or hardcopy, which supports the Patient Medication Profile. The Patient Daily Medication Record provides a daily refill-by-refill audit trail on all drugs dispensed and supplements the base document, the Patient Medication profile. This record is produced on a daily basis. It may be used to fill patient medication orders, for transport to the patient care area. This record must show all medications dispensed on any given day.
The purpose of this section is to provide standards for remote or off-site order entry in hospital pharmacies within the state of Arkansas.
The above competencies shall be in written policy and procedure and shall include training, testing and ongoing assessment of skills.
The following is a list of categories of drugs which are acceptable in emergency kits in facilities with institutional pharmaceutical services permits in accordance with this regulation:
Schedule II injectable
Limit: one (1)
Maximum quantity: two (2)
Limit: one (1)
Maximum quantity: ten (10)
Limit: two (2)
Maximum quantity: six (6)
Limit: one (1)
Maximum quantity: four (4)
Limit: one (1)
Maximum quantity: four (4) (Amended 10/2001)
The Arkansas State Board of Pharmacy may provide for the issuance of a charitable clinic pharmacy permit to clinics and facilities furnishing medical care and dental care to poor and underprivileged persons, in which drugs are dispensed without charge to such persons on orders or prescriptions of practitioners authorized by law to prescribe or administer said drugs and to which the requirements of a licensed pharmacist on duty for a minimum of forty (40) hours shall not apply.
All medication for patients shall be on individual prescription basis, and the pharmacist shall dispense drugs, properly labeled, and adhere to the requirements for proper storage, safeguarding, preparation and record keeping for prescription drugs.
All policies and procedures related to the charitable clinic pharmacy permit must first be approved by the Board staff before a permit will be issued to ensure compliance with all existing laws and regulations.
The staff of the Board of Pharmacy is authorized to approve and issue charitable clinic permits for:
Other facilities meeting the requirements of this regulation and where a pharmacist is present when medications are provided to the patient shall not be restricted to a medication formulary. (Revised 04/30/93)
The charitable clinic pharmacy shall dispense donated prescriptions medications only to indigent patients as defined in Ark. Code Ann. § 17-92-1102(4)
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.