22 Tex. Admin. Code § 291.33 - Operational Standards
(a) Licensing
requirements.
(1) A Class A pharmacy shall
register annually or biennially with the board on a pharmacy license
application provided by the board, following the procedures as specified in
§
291.1 of this title (relating to
Pharmacy License Application).
(2)
A Class A pharmacy which changes ownership shall notify the board within ten
days of the change of ownership and apply for a new and separate license as
specified in §
291.3 of this title (relating to
Required Notifications).
(3) A
Class A pharmacy which changes location and/or name shall notify the board as
specified in §
291.3 of this title.
(4) A Class A pharmacy owned by a partnership
or corporation which changes managing officers shall notify the board in
writing of the names of the new managing officers within ten days of the
change, following the procedures as specified in §
291.3 of this title.
(5) A Class A pharmacy shall notify the board
in writing within ten days of closing, following the procedures as specified in
§
291.5 of this title (relating to
Closing a Pharmacy).
(6) A separate
license is required for each principal place of business and only one pharmacy
license may be issued to a specific location.
(7) A fee as specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for the issuance and renewal of a
license and the issuance of an amended license.
(8) A Class A pharmacy, licensed under the
provisions of the Act, §560.051(a)(1), which also operates another type of
pharmacy which would otherwise be required to be licensed under the Act,
§560.051(a)(2) concerning Nuclear Pharmacy (Class B), is not required to
secure a license for such other type of pharmacy; provided, however, such
licensee is required to comply with the provisions of Subchapter C of this
chapter (relating to Nuclear Pharmacy (Class B)), to the extent such sections
are applicable to the operation of the pharmacy.
(9) A Class A pharmacy engaged in the
compounding of non-sterile preparations shall comply with the provisions of
§
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(10) A Class A pharmacy shall not compound
sterile preparations.
(11) A Class
A pharmacy engaged in the provision of remote pharmacy services, including
storage and dispensing of prescription drugs, shall comply with the provisions
of §
291.121 of this title (relating to
Remote Pharmacy Services).
(12)
Class A pharmacy engaged in centralized prescription dispensing and/or
prescription drug or medication order processing shall comply with the
provisions of §
291.123 of this title (relating to
Central Prescription Drug or Medication Order Processing) and/or §
291.125 of this title (relating to
Centralized Prescription Dispensing).
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an
orderly fashion and kept clean. All required equipment shall be clean and in
good operating condition.
(B) A
Class A pharmacy shall have a sink with hot and cold running water within the
pharmacy, exclusive of restroom facilities, available to all pharmacy personnel
and maintained in a sanitary condition.
(C) A Class A pharmacy which serves the
general public shall contain an area which is suitable for confidential patient
counseling.
(i) Such counseling area shall be:
(I) easily accessible to both patient and
pharmacists and not allow patient access to prescription drugs; and
(II) designed to maintain the confidentiality
and privacy of the pharmacist/patient communication.
(ii) In determining whether the area is
suitable for confidential patient counseling and designed to maintain the
confidentiality and privacy of the pharmacist/patient communication, the board
may consider factors such as the following:
(I) the proximity of the counseling area to
the check-out or cash register area;
(II) the volume of pedestrian traffic in and
around the counseling area;
(III)
the presence of walls or other barriers between the counseling area and other
areas of the pharmacy; and
(IV) any
evidence of confidential information being overheard by persons other than the
patient or patient's agent or the pharmacist or agents of the
pharmacist.
(D) The pharmacy shall be properly lighted
and ventilated.
(E) The temperature
of the pharmacy shall be maintained within a range compatible with the proper
storage of drugs. The temperature of the refrigerator shall be maintained
within a range compatible with the proper storage of drugs requiring
refrigeration.
(F) Animals,
including birds and reptiles, shall not be kept within the pharmacy and in
immediately adjacent areas under the control of the pharmacy. This provision
does not apply to fish in aquariums, service animals accompanying disabled
persons, or animals for sale to the general public in a separate area that is
inspected by local health jurisdictions.
(G) If the pharmacy has flammable materials,
the pharmacy shall have a designated area for the storage of flammable
materials. Such area shall meet the requirements set by local and state fire
laws.
(2) Security.
(A) Each pharmacist while on duty shall be
responsible for the security of the prescription department, including
provisions for effective control against theft or diversion of prescription
drugs, and records for such drugs.
(B) The prescription department shall be
locked by key, combination or other mechanical or electronic means to prohibit
unauthorized access when a pharmacist is not on-site except as provided in
subparagraphs (C) and (D) of this paragraph and paragraph (3) of this
subsection. The following is applicable:
(i)
If the prescription department is closed at any time when the rest of the
facility is open, the prescription department must be physically or
electronically secured. The security may be accomplished by means such as floor
to ceiling walls; walls, partitions, or barriers at least 9 feet 6 inches high;
electronically monitored motion detectors; pull down sliders; or other systems
or technologies that will secure the pharmacy from unauthorized entrance when
the pharmacy is closed. Pharmacies licensed prior to June 1, 2009, shall be
exempt from this provision unless the pharmacy changes location. Change of
location shall include the relocation of the pharmacy within the licensed
address. A pharmacy licensed prior to June 1, 2009 that files a change of
ownership but does not change location shall be exempt from the
provisions.
(ii) The pharmacy's
key, combination, or other mechanical or electronic means of locking the
pharmacy may not be duplicated without the authorization of the
pharmacist-in-charge or owner.
(iii) At a minimum, the pharmacy must have a
basic alarm system with off-site monitoring and perimeter and motion sensors.
The pharmacy may have additional security by video surveillance camera
systems.
(C) Prior to
authorizing individuals to enter the prescription department, the
pharmacist-in-charge or owner may designate persons who may enter the
prescription department to perform functions, other than dispensing functions
or prescription processing, documented by the pharmacist-in-charge including
access to the prescription department by other pharmacists, pharmacy personnel
and other individuals. The pharmacy must maintain written documentation of
authorized individuals other than individuals employed by the pharmacy who
accessed the prescription department when a pharmacist is not
on-site.
(D) Only persons
designated either by name or by title including such titles as "relief" or
"floater" pharmacist, in writing by the pharmacist-in-charge may unlock the
prescription department except in emergency situations. An additional key to or
instructions on accessing the prescription department may be maintained in a
secure location outside the prescription department for use during an emergency
or as designated by the pharmacist-in-charge.
(E) Written policies and procedures for the
pharmacy's security shall be developed and implemented by the
pharmacist-in-charge and/or the owner of the pharmacy. Such policies and
procedures may include quarterly audits of controlled substances commonly
abused or diverted; perpetual inventories for the comparison of the receipt,
dispensing, and distribution of controlled substances; monthly reports from the
pharmacy's wholesaler(s) of controlled substances purchased by the pharmacy;
opening and closing procedures; product storage and placement; and central
management oversight.
(3) Temporary absence of pharmacist.
(A) On-site supervision by pharmacist.
(i) If a pharmacy is staffed by only one
pharmacist, the pharmacist may leave the prescription department for short
periods of time without closing the prescription department and removing
pharmacy technicians, pharmacy technician trainees, and other pharmacy
personnel from the prescription department provided the following conditions
are met:
(I) at least one pharmacy technician
remains in the prescription department;
(II) the pharmacist remains on-site at the
licensed location of the pharmacy and is immediately available;
(III) the pharmacist reasonably believes that
the security of the prescription department will be maintained in his or her
absence. If in the professional judgment of the pharmacist, the pharmacist
determines that the prescription department should close during his or her
absence, then the pharmacist shall close the prescription department and remove
the pharmacy technicians, pharmacy technician trainees, and other pharmacy
personnel from the prescription department during his or her absence;
and
(IV) a notice is posted which
includes the following information:
(-a-) the
pharmacist is on a break and the time the pharmacist will return; and
(-b-) pharmacy technicians may begin the
processing of prescription drug orders or refills brought in during the
pharmacist's absence, but the prescription or refill may not be delivered to
the patient or the patient's agent until the pharmacist verifies the accuracy
of the prescription.
(ii) During the time a pharmacist is absent
from the prescription department, only pharmacy technicians who have completed
the pharmacy's training program may perform the following duties, provided a
pharmacist verifies the accuracy of all acts, tasks, and functions performed by
the pharmacy technicians prior to delivery of the prescription to the patient
or the patient's agent:
(I) initiating and
receiving refill authorization requests;
(II) entering prescription data into a data
processing system;
(III) taking a
stock bottle from the shelf for a prescription;
(IV) preparing and packaging prescription
drug orders (e.g., counting tablets/capsules, measuring liquids, or placing
them in the prescription container);
(V) affixing prescription labels and
auxiliary labels to the prescription container;
(VI) prepackaging and labeling prepackaged
drugs;
(VII) receiving oral
prescription drug orders for dangerous drugs and reducing these orders to
writing, either manually or electronically;
(VIII) transferring or receiving a transfer
of original prescription information for dangerous drugs on behalf of a
patient; and
(IX) contacting a
prescriber for information regarding an existing prescription for a dangerous
drug.
(iii) Upon return
to the prescription department, the pharmacist shall:
(I) conduct a drug regimen review as
specified in subsection (c)(2) of this section; and
(II) verify the accuracy of all acts, tasks,
and functions performed by the pharmacy technicians prior to delivery of the
prescription to the patient or the patient's agent.
(iv) An agent of the pharmacist may deliver a
previously verified prescription to the patient or his or her agent provided a
record of the delivery is maintained containing the following information:
(I) date of the delivery;
(II) unique identification number of the
prescription drug order;
(III)
patient's name;
(IV) patient's
phone number or the phone number of the person picking up the prescription;
and
(V) signature of the person
picking up the prescription.
(v) Any prescription delivered to a patient
when a pharmacist is not in the prescription department must meet the
requirements for a prescription delivered to a patient as described in
subsection (c)(1)(F) of this section.
(vi) During the times a pharmacist is absent
from the prescription department a pharmacist intern shall be considered a
registered pharmacy technician and may perform only the duties of a registered
pharmacy technician.
(vii) In
pharmacies with two or more pharmacists on duty, the pharmacists shall stagger
their breaks and meal periods so that the prescription department is not left
without a pharmacist on duty.
(B) Pharmacist is off-site.
(i) The prescription department must be
secured with procedures for entry during the time that a pharmacy is not under
the continuous on-site supervision of a pharmacist and the pharmacy is not open
for pharmacy services.
(ii)
Pharmacy technicians and pharmacy technician trainees may not perform any
duties of a pharmacy technician or pharmacy technician trainee during the time
that the pharmacist is off-site.
(iii) A pharmacy may use an automated
dispensing and delivery system as specified in §
291.121(d) of
this title for pick-up of a previously verified prescription by a patient or
patient's agent.
(iv) An agent of
the pharmacist may deliver a previously verified prescription to a patient or
patient's agent during short periods of time when a pharmacist is off-site,
provided the following conditions are met:
(I)
short periods of time may not exceed two consecutive hours in a 24 hour
period;
(II) a notice is posted
which includes the following information:
(-a-) the pharmacist is off-site and not
present in the pharmacy;
(-b-) no
new prescriptions may be prepared at the pharmacy but previously verified
prescriptions may be delivered to the patient or the patient's agent;
and
(-c-) the date/time when the
pharmacist will return;
(III) the pharmacy must maintain
documentation of the absences of the pharmacist(s); and
(IV) the prescription department is locked
and secured to prohibit unauthorized entry.
(v) During the time a pharmacist is absent
from the prescription department and is off-site, a record of prescriptions
delivered must be maintained and contain the following information:
(I) date and time of the delivery;
(II) unique identification number of the
prescription drug order;
(III)
patient's name;
(IV) patient's
phone number or the phone number of the person picking up the prescription;
and
(V) signature of the person
picking up the prescription.
(vi) Any prescription delivered to a patient
when a pharmacist is not on-site at the pharmacy must meet the requirements for
a prescription delivered to a patient as described in subsection (c)(1)(F) of
this section.
(c) Prescription dispensing and delivery.
(1) Patient counseling and provision of drug
information.
(A) To optimize drug therapy, a
pharmacist shall communicate to the patient or the patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgment the pharmacist deems significant, such as the following:
(i) name and description of the drug or
device;
(ii) dosage form, dosage,
route of administration, and duration of drug therapy;
(iii) special directions and precautions for
preparation, administration, and use by the patient;
(iv) 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;
(v) techniques for self-monitoring of drug
therapy;
(vi) proper
storage;
(vii) refill information;
and
(viii) action to be taken in
the event of a missed dose.
(B) Such communication shall be:
(i) provided to new and existing patients of
a pharmacy with each new prescription drug order. A new prescription drug order
is one that has not been dispensed by the pharmacy to the patient in the same
dosage and strength within the last year;
(ii) provided for any prescription drug order
dispensed by the pharmacy on the request of the patient or patient's
agent;
(iii) communicated orally
unless the patient or patient's agent is not at the pharmacy or a specific
communication barrier prohibits such oral communication;
(iv) documented by recording the initials or
identification code of the pharmacist providing the counseling in the
prescription dispensing record as follows:
(I)
on the original hard-copy prescription, provided the counseling pharmacist
clearly records his or her initials on the prescription for the purpose of
identifying who provided the counseling;
(II) in the pharmacy's data processing
system;
(III) in an electronic
logbook; or
(IV) in a hard-copy
log; and
(v) reinforced
with written information relevant to the prescription and provided to the
patient or patient's agent. The following is applicable concerning this written
information:
(I) Written information must be
in plain language designed for the patient and printed in an easily readable
font size comparable to but no smaller than ten-point Times Roman. This
information may be provided to the patient in an electronic format, such as by
e-mail, if the patient or patient's agent requests the information in an
electronic format and the pharmacy documents the request.
(II) When a compounded preparation is
dispensed, information shall be provided for the major active ingredient(s), if
available.
(III) For new drug
entities, if no written information is initially available, the pharmacist is
not required to provide information until such information is available,
provided:
(-a-) the pharmacist informs the
patient or the patient's agent that the product is a new drug entity and
written information is not available;
(-b-) the pharmacist documents the fact that
no written information was provided; and
(-c-) if the prescription is refilled after
written information is available, such information is provided to the patient
or patient's agent.
(IV)
The written information accompanying the prescription or the prescription label
shall contain the statement "Do not flush unused medications or pour down a
sink or drain." A drug product on a list developed by the Federal Food and Drug
Administration of medicines recommended for disposal by flushing is not
required to bear this statement.
(C) Only a pharmacist may verbally provide
drug information to a patient or patient's agent and answer questions
concerning prescription drugs. Non-pharmacist personnel and/or the pharmacy's
computer system may not ask questions of a patient or patient's agent which are
intended to screen and/or limit interaction with the pharmacist.
(D) Nothing in this subparagraph shall be
construed as requiring a pharmacist to provide consultation when a patient or
patient's agent refuses such consultation. The pharmacist shall document such
refusal for consultation.
(E) In
addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a
prescription drug order is delivered to the patient at the pharmacy, the
following is applicable:
(i) So that a patient
will have access to information concerning his or her prescription, a
prescription may not be delivered to a patient unless a pharmacist is in the
pharmacy, except as provided in subsection (b)(3) of this section.
(ii) Any prescription delivered to a patient
when a pharmacist is not in the pharmacy must meet the requirements described
in subparagraph (F) of this paragraph.
(F) In addition to the requirements of
subparagraphs (A) - (D) of this paragraph, if a prescription drug order is
delivered to the patient or his or her agent at the patient's residence or
other designated location, the following is applicable:
(i) The information as specified in
subparagraph (A) of this paragraph shall be delivered with the dispensed
prescription in writing.
(ii) If
prescriptions are routinely delivered outside the area covered by the
pharmacy's local telephone service, the pharmacy shall provide a toll-free
telephone line which is answered during normal business hours to enable
communication between the patient and a pharmacist.
(iii) The pharmacist shall place on the
prescription container or on a separate sheet delivered with the prescription
container in both English and Spanish the local and, if applicable, toll-free
telephone number of the pharmacy and the statement: "Written information about
this prescription has been provided for you. Please read this information
before you take the medication. If you have questions concerning this
prescription, a pharmacist is available during normal business hours to answer
these questions at (insert the pharmacy's local and toll-free telephone
numbers)."
(iv) The pharmacy shall
maintain and use adequate storage or shipment containers and use shipping
processes to ensure drug stability and potency. Such shipping processes shall
include the use of appropriate packaging material and/or devices to ensure that
the drug is maintained at an appropriate temperature range to maintain the
integrity of the medication throughout the delivery process.
(v) The pharmacy shall use a delivery system
which is designed to ensure that the drugs are delivered to the appropriate
patient.
(G) The
provisions of this paragraph do not apply to patients in facilities where drugs
are administered to patients by a person required to do so by the laws of the
state (i.e., nursing homes).
(2) Pharmaceutical care services.
(A) Drug regimen review.
(i) For the purpose of promoting therapeutic
appropriateness, a pharmacist shall, prior to or at the time of dispensing a
prescription drug order, review the patient's medication record. Such review
shall at a minimum identify clinically significant:
(I) known allergies;
(II) rational
therapy-contraindications;
(III)
reasonable dose and route of administration;
(IV) reasonable directions for use;
(V) duplication of therapy;
(VI) drug-drug interactions;
(VII) drug-food interactions;
(VIII) drug-disease interactions;
(IX) adverse drug reactions; and
(X) proper utilization, including
overutilization or underutilization.
(ii) Upon identifying any clinically
significant conditions, situations, or items listed in clause (i) of this
subparagraph, the pharmacist shall take appropriate steps to avoid or resolve
the problem including consultation with the prescribing practitioner. The
pharmacist shall document such occurrences as specified in subparagraph (C) of
this paragraph.
(iii) The drug
regimen review may be conducted by remotely accessing the pharmacy's electronic
database from outside the pharmacy by:
(I) an
individual Texas licensed pharmacist employee of the pharmacy provided the
pharmacy establishes controls to protect the privacy of the patient and the
security of confidential records; or
(II) a pharmacist employed by a Class E
pharmacy provided the pharmacies have entered into a written contract or
agreement which outlines the services to be provided and the responsibilities
and accountabilities of each pharmacy in compliance with federal and state laws
and regulations.
(iv)
Prior to dispensing, any questions regarding a prescription drug order must be
resolved with the prescriber and written documentation of these discussions
made and maintained as specified in subparagraph (C) of this
paragraph.
(B) Other
pharmaceutical care services which may be provided by pharmacists include, but
are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as allowed under the
provisions of the Medical Practice Act;
(ii) administering immunizations and
vaccinations under written protocol of a physician;
(iii) managing patient compliance
programs;
(iv) providing
preventative health care services; and
(v) providing case management of patients who
are being treated with high-risk or high-cost drugs, or who are considered
"high risk" due to their age, medical condition, family history, or related
concern.
(C)
Documentation of consultation. When a pharmacist consults a prescriber as
described in subparagraph (A) of this paragraph, the pharmacist shall document
on the prescription or in the pharmacy's data processing system associated with
the prescription such occurrences and shall include the following information:
(i) date the prescriber was
consulted;
(ii) name of the person
communicating the prescriber's instructions;
(iii) any applicable information pertaining
to the consultation; and
(iv)
initials or identification code of the pharmacist performing the consultation
clearly recorded for the purpose of identifying the pharmacist who performed
the consultation.
(3) Substitution of generically equivalent
drugs or interchangeable biological products. A pharmacist may dispense a
generically equivalent drug or interchangeable biological product and shall
comply with the provisions of §
309.3 of this title (relating to
Substitution Requirements).
(4)
Substitution of dosage form.
(A) As specified
in §562.012 of the Act, a pharmacist may dispense a dosage form of a drug
product different from that prescribed, such as a tablet instead of a capsule
or liquid instead of tablets, provided:
(i)
the patient consents to the dosage form substitution; and
(ii) the dosage form so dispensed:
(I) contains the identical amount of the
active ingredients as the dosage prescribed for the patient;
(II) is not an enteric-coated or time release
product; and
(III) does not alter
desired clinical outcomes.
(B) Substitution of dosage form may not
include the substitution of a product that has been compounded by the
pharmacist unless the pharmacist contacts the practitioner prior to dispensing
and obtains permission to dispense the compounded product.
(5) Therapeutic Drug Interchange. A switch to
a drug providing a similar therapeutic response to the one prescribed shall not
be made without prior approval of the prescribing practitioner. This paragraph
does not apply to generic substitution. For generic substitution, see the
requirements of paragraph (3) of this subsection.
(A) The patient shall be notified of the
therapeutic drug interchange prior to, or upon delivery of, the dispensed
prescription to the patient. Such notification shall include:
(i) a description of the change;
(ii) the reason for the change;
(iii) whom to notify with questions
concerning the change; and
(iv)
instructions for return of the drug if not wanted by the patient.
(B) The pharmacy shall maintain
documentation of patient notification of therapeutic drug interchange which
shall include:
(i) the date of the
notification;
(ii) the method of
notification;
(iii) a description
of the change; and
(iv) the reason
for the change.
(C) The
provisions of this paragraph do not apply to prescriptions for patients in
facilities where drugs are administered to patients by a person required to do
so by the laws of this state if the practitioner issuing the prescription has
agreed to use of a formulary that includes a listing of therapeutic
interchanges that the practitioner has agreed to allow. The pharmacy must
maintain a copy of the formulary including a list of the practitioners that
have agreed to the formulary and the signatures of these
practitioners.
(6)
Prescription containers.
(A) A drug dispensed
pursuant to a prescription drug order shall be dispensed in a child-resistant
container unless:
(i) the patient or the
practitioner requests the prescription not be dispensed in a child-resistant
container; or
(ii) the product is
exempted from requirements of the Poison Prevention Packaging Act of
1970.
(B) A drug
dispensed pursuant to a prescription drug order shall be dispensed in an
appropriate container as specified on the manufacturer's container.
(C) Prescription containers or closures shall
not be re-used. However, if a patient or patient's agent has difficulty reading
or understanding a prescription label, a prescription container may be reused
provided:
(i) the container is designed to
provide audio-recorded information about the proper use of the prescription
medication;
(ii) the container is
reused for the same patient;
(iii)
the container is cleaned; and
(iv)
a new safety closure is used each time the prescription container is
reused.
(7)
Labeling.
(A) At the time of delivery of the
drug, the dispensing container shall bear a label in plain language and printed
in an easily readable font size, unless otherwise specified, with at least the
following information:
(i) name, address and
phone number of the pharmacy;
(ii)
unique identification number of the prescription that is printed in an easily
readable font size comparable to but no smaller than ten-point Times
Roman;
(iii) date the prescription
is dispensed;
(iv) initials or an
identification code of the dispensing pharmacist;
(v) name of the prescribing
practitioner;
(vi) if the
prescription was signed by a pharmacist, the name of the pharmacist who signed
the prescription for a dangerous drug under delegated authority of a physician
as specified in Subtitle B, Chapter 157, Occupations Code;
(vii) name of the patient or if such drug was
prescribed for an animal, the species of the animal and the name of the owner
that is printed in an easily readable font size comparable to but no smaller
than ten-point Times Roman. The name of the patient's partner or family member
is not required to be on the label of a drug prescribed for a partner for a
sexually transmitted disease or for a patient's family members if the patient
has an illness determined by the Centers for Disease Control and Prevention,
the World Health Organization, or the Governor's office to be
pandemic;
(viii) instructions for
use that are printed in an easily readable font size comparable to but no
smaller than ten-point Times Roman;
(ix) quantity dispensed;
(x) appropriate ancillary instructions such
as storage instructions or cautionary statements such as warnings of potential
harmful effects of combining the drug product with any product containing
alcohol;
(xi) if the prescription
is for a Schedule II - IV controlled substance, the statement "Caution: Federal
law prohibits the transfer of this drug to any person other than the patient
for whom it was prescribed";
(xii)
if the pharmacist has selected a generically equivalent drug or interchangeable
biological product pursuant to the provisions of the Act, Chapter 562, the
statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'"
where "Brand Name" is the actual name of the brand name product
prescribed;
(xiii) the name and
strength of the actual drug or biological product dispensed that is printed in
an easily readable size comparable to but no smaller than ten-point Times
Roman, unless otherwise directed by the prescribing practitioner;
(I) The name shall be either:
(-a-) the brand name; or
(-b-) if no brand name, then the generic drug
or interchangeable biological product name and name of the manufacturer or
distributor of such generic drug or interchangeable biological product. (The
name of the manufacturer or distributor may be reduced to an abbreviation or
initials, provided the abbreviation or initials are sufficient to identify the
manufacturer or distributor. For combination drug products or non-sterile
compounded drug preparations having no brand name, the principal active
ingredients shall be indicated on the label).
(II) Except as provided in clause (xii) of
this subparagraph, the brand name of the prescribed drug or biological product
shall not appear on the prescription container label unless it is the drug
product actually dispensed.
(xiv) if the drug is dispensed in a container
other than the manufacturer's original container, the date after which the
prescription should not be used or beyond-use-date. Unless otherwise specified
by the manufacturer, the beyond-use-date shall be one year from the date the
drug is dispensed or the manufacturer's expiration date, whichever is earlier.
The beyond-use-date may be placed on the prescription label or on a flag label
attached to the bottle. A beyond-use-date is not required on the label of a
prescription dispensed to a person at the time of release from prison or jail
if the prescription is for not more than a 10-day supply of medication;
and
(xv) either on the prescription
label or the written information accompanying the prescription, the statement
"Do not flush unused medications or pour down a sink or drain." A drug product
on a list developed by the Federal Food and Drug Administration of medicines
recommended for disposal by flushing is not required to bear this
statement.
(B) If the
prescription label required in subparagraph (A) of this paragraph is printed in
a type size smaller than ten-point Times Roman, the pharmacy shall provide the
patient written information containing the information as specified in
subparagraph (A) of this paragraph in an easily readable font size comparable
to but no smaller than ten-point Times Roman.
(C) The label is not required to include the
initials or identification code of the dispensing pharmacist as specified in
subparagraph (A) of this paragraph if the identity of the dispensing pharmacist
is recorded in the pharmacy's data processing system. The record of the
identity of the dispensing pharmacist shall not be altered in the pharmacy's
data processing system.
(D) The
dispensing container is not required to bear the label as specified in
subparagraph (A) of this paragraph if:
(i) the
drug is prescribed for administration to an ultimate user who is
institutionalized in a licensed health care institution (e.g., nursing home,
hospice, hospital);
(ii) no more
than a 90-day supply is dispensed at one time;
(iii) the drug is not in the possession of
the ultimate user prior to administration;
(iv) the pharmacist-in-charge has determined
that the institution:
(I) maintains medication
administration records which include adequate directions for use for the
drug(s) prescribed;
(II) maintains
records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for
the control and storage of the drug(s); and
(v) the dispensing container bears a label
that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the
prescription;
(-c-) name and
strength of the drug dispensed;
(-d-) name of the patient; and
(-e-) name of the prescribing practitioner
or, if applicable, the name of the pharmacist who signed the prescription drug
order;
(II) if the drug
is dispensed in a container other than the manufacturer's original container,
specifies the date after which the prescription should not be used or
beyond-use-date. Unless otherwise specified by the manufacturer, the
beyond-use-date shall be one year from the date the drug is dispensed or the
manufacturer's expiration date, whichever is earlier. The beyond-use-date may
be placed on the prescription label or on a flag label attached to the bottle.
A beyond-use-date is not required on the label of a prescription dispensed to a
person at the time of release from prison or jail if the prescription is for
not more than a 10-day supply of medication; and
(III) sets forth the directions for use and
cautionary statements, if any, contained on the prescription drug order or
required by law.
(8) Returning Undelivered Medication to
Stock.
(A) A pharmacist may not accept an
unused prescription or drug, in whole or in part, for the purpose of resale or
re-dispensing to any person after the prescription or drug has been originally
dispensed or sold, except as provided in §
291.8 of this title (relating to
Return of Prescription Drugs) or Subchapter M, Chapter 431, Health and Safety
Code, or Chapter 442, Health and Safety Code. Prescriptions that have not been
picked up by or delivered to the patient or patient's agent may be returned to
the pharmacy's stock for dispensing.
(B) A pharmacist shall evaluate the quality
and safety of the prescriptions to be returned to stock.
(C) Prescriptions returned to stock for
dispensing shall not be mixed within the manufacturer's container.
(D) Prescriptions returned to stock for
dispensing should be used as soon as possible and stored in the dispensing
container. The expiration date of the medication shall be the lesser of one
year from the dispensing date on the prescription label or the manufacturer's
expiration date if dispensed in the manufacturer's original
container.
(E) At the time of
dispensing, the prescription medication shall be placed in a new prescription
container and not dispensed in the previously labeled container unless the
label can be completely removed. However, if the medication is in the
manufacturer's original container, the pharmacy label must be removed so that
no confidential patient information is released.
(9) Redistribution of Donated Prepackaged
Prescription Drugs.
(A) A participating
provider may dispense to a recipient donated prescription drugs that are
prepackaged and labeled in accordance with §
442.0515,
Health and Safety Code, and this paragraph.
(B) Drugs may be prepackaged in quantities
suitable for distribution to a recipient only by a pharmacist or by pharmacy
technicians or pharmacy technician trainees under the direction and direct
supervision of a pharmacist.
(C)
The label of a prepackaged prescription drug a participating provider dispenses
to a recipient shall indicate:
(i) brand name
and strength of the drug; or if no brand name, then the generic name, strength,
and name of the manufacturer or distributor;
(ii) participating provider's lot
number;
(iii) participating
provider's beyond use date; and
(iv) quantity of the drug, if the quantity is
greater than one.
(D)
Records of prepackaged prescription drugs dispensed to a recipient shall be
maintained to show:
(i) name of the drug,
strength, and dosage form;
(ii)
participating provider's lot number;
(iii) manufacturer or distributor;
(iv) manufacturer's lot number;
(v) manufacturer's expiration date;
(vi) quantity per prepackaged unit;
(vii) number of prepackaged units;
(viii) date packaged;
(ix) name, initials, or written or electronic
signature of the prepacker; and
(x)
written or electronic signature of the responsible pharmacist.
(E) Stock packages, repackaged
units, and control records shall be quarantined together until checked/released
by the pharmacist.
(d) Equipment and supplies. Class A
pharmacies dispensing prescription drug orders shall have the following
equipment and supplies:
(1) data processing
system including a printer or comparable equipment;
(2) refrigerator;
(3) adequate supply of child-resistant,
light-resistant, tight, and if applicable, glass containers;
(4) adequate supply of prescription, poison,
and other applicable labels;
(5)
appropriate equipment necessary for the proper preparation of prescription drug
orders; and
(6) metric-apothecary
weight and measure conversion charts.
(e) Library. A reference library shall be
maintained which includes the following in hard-copy or electronic format:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and
rules;
(C) Texas Controlled
Substances Act and rules; and
(D)
Federal Controlled Substances Act and rules (or official publication describing
the requirements of the Federal Controlled Substances Act and rules);
(2) at least one current or
updated reference from each of the following categories:
(A) a patient prescription drug information
reference text or leaflets which are designed for the patient and must be
available to the patient;
(B) at
least one current or updated general drug information reference which is
required to contain drug interaction information including information needed
to determine severity or significance of the interaction and appropriate
recommendations or actions to be taken; and
(C) if the pharmacy dispenses veterinary
prescriptions, a general reference text on veterinary drugs; and
(3) basic antidote information and
the telephone number of the nearest Regional Poison Control Center.
(f) Drugs.
(1) Procurement and storage.
(A) The pharmacist-in-charge shall have the
responsibility for the procurement and storage of drugs, but may receive input
from other appropriate staff relative to such responsibility.
(B) Prescription drugs and devices and
nonprescription Schedule V controlled substances shall be stored within the
prescription department or a locked storage area.
(C) All drugs shall be stored at the proper
temperature, as defined in the USP/NF and §
291.15 of this title (relating to
Storage of Drugs).
(2)
Out-of-date drugs or devices.
(A) Any drug or
device bearing an expiration date shall not be dispensed beyond the expiration
date of the drug or device.
(B)
Outdated drugs or devices shall be removed from dispensing stock and shall be
quarantined together until such drugs or devices are disposed of
properly.
(3)
Nonprescription Schedule V controlled substances.
(A) Schedule V controlled substances
containing codeine, dihydrocodeine, or any of the salts of codeine or
dihydrocodeine may not be distributed without a prescription drug order from a
practitioner.
(B) A pharmacist may
distribute nonprescription Schedule V controlled substances which contain no
more than 15 milligrams of opium per 29.5729 ml or per 28.35 Gm provided:
(i) such distribution is made only by a
pharmacist; a nonpharmacist employee may not distribute a nonprescription
Schedule V controlled substance even if under the supervision of a pharmacist;
however, after the pharmacist has fulfilled professional and legal
responsibilities, the actual cash, credit transaction, or delivery may be
completed by a nonpharmacist:
(ii)
not more than 240 ml (eight fluid ounces), or not more than 48 solid dosage
units of any substance containing opium, may be distributed to the same
purchaser in any given 48-hour period without a prescription drug
order;
(iii) the purchaser is at
least 18 years of age; and
(iv) the
pharmacist requires every purchaser not known to the pharmacist to furnish
suitable identification (including proof of age where appropriate).
(C) A record of such distribution
shall be maintained by the pharmacy in a bound record book. The record shall
contain the following information:
(i) true
name of the purchaser;
(ii) current
address of the purchaser;
(iii)
name and quantity of controlled substance purchased;
(iv) date of each purchase; and
(v) signature or written initials of the
distributing pharmacist.
(4) Class A Pharmacies may not sell,
purchase, trade or possess prescription drug samples, unless the pharmacy meets
the requirements as specified in §
291.16 of this title (relating to
Samples).
(g)
Prepackaging of drugs.
(1) Drugs may be
prepackaged in quantities suitable for internal distribution only by a
pharmacist or by pharmacy technicians or pharmacy technician trainees under the
direction and direct supervision of a pharmacist.
(2) The label of a prepackaged unit shall
indicate:
(A) brand name and strength of the
drug; or if no brand name, then the generic name, strength, and name of the
manufacturer or distributor;
(B)
facility's lot number;
(C)
facility's beyond use date; and
(D)
quantity of the drug, if the quantity is greater than one.
(3) Records of prepackaging shall be
maintained to show:
(A) name of the drug,
strength, and dosage form;
(B)
facility's lot number;
(C)
manufacturer or distributor;
(D)
manufacturer's lot number;
(E)
manufacturer's expiration date;
(F)
quantity per prepackaged unit;
(G)
number of prepackaged units;
(H)
date packaged;
(I) name, initials,
or electronic signature of the prepacker; and
(J) signature, or electronic signature of the
responsible pharmacist.
(4) Stock packages, repackaged units, and
control records shall be quarantined together until checked/released by the
pharmacist.
(h)
Customized patient medication packages.
(1)
Purpose. In lieu of dispensing two or more prescribed drug products in separate
containers, a pharmacist may, with the consent of the patient, the patient's
caregiver, or the prescriber, provide a customized patient medication package
(patient med-pak).
(2) Label.
(A) The patient med-pak shall bear a label
stating:
(i) the name of the
patient;
(ii) the unique
identification number for the patient med-pak itself and a separate unique
identification number for each of the prescription drug orders for each of the
drug products contained therein;
(iii) the name, strength, physical
description or identification, and total quantity of each drug product
contained therein;
(iv) the
directions for use and cautionary statements, if any, contained in the
prescription drug order for each drug product contained therein;
(v) if applicable, a warning of the potential
harmful effect of combining any form of alcoholic beverage with any drug
product contained therein;
(vi) any
storage instructions or cautionary statements required by the official
compendia;
(vii) the name of the
prescriber of each drug product;
(viii) the name, address, and telephone
number of the pharmacy;
(ix) the
initials or an identification code of the dispensing pharmacist;
(x) the date after which the prescription
should not be used or beyond-use-date. Unless otherwise specified by the
manufacturer, the beyond-use-date shall be one year from the date the med-pak
is dispensed or the earliest manufacturer's expiration date for a product
contained in the med-pak if it is less than one-year from the date dispensed.
The beyond-use-date may be placed on the prescription label or on a flag label
attached to the bottle. A beyond-use-date is not required on the label of a
prescription dispensed to a person at the time of release from prison or jail
if the prescription is for not more than a 10-day supply of
medication;
(xi) either on the
prescription label or the written information accompanying the prescription,
the statement "Do not flush unused medications or pour down a sink or drain." A
drug product on a list developed by the Federal Food and Drug Administration of
medicines recommended for disposal by flushing is not required to bear this
statement; and
(xii) any other
information, statements, or warnings required for any of the drug products
contained therein.
(B)
If the patient med-pak allows for the removal or separation of the intact
containers therefrom, each individual container shall bear a label identifying
each of the drug product contained therein.
(C) The dispensing container is not required
to bear the label as specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration
to an ultimate user who is institutionalized in a licensed health care
institution (e.g., nursing home, hospice, hospital);
(ii) no more than a 90-day supply is
dispensed at one time;
(iii) the
drug is not in the possession of the ultimate user prior to
administration;
(iv) the
pharmacist-in-charge has determined that the institution:
(I) maintains medication administration
records which include adequate directions for use for the drug(s)
prescribed;
(II) maintains records
of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for
the control and storage of the drug(s); and
(v) the dispensing container bears a label
that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) name and strength of each drug product
dispensed;
(-c-) name of the
patient; and
(-d-) name of the
prescribing practitioner of each drug product, or the pharmacist who signed the
prescription drug order;
(II) the date after which the prescription
should not be used or beyond-use-date. Unless otherwise specified by the
manufacturer, the beyond-use-date shall be one year from the date the med-pak
is dispensed or the earliest manufacturer's expiration date for a product
contained in the med-pak if it is less than one-year from the date dispensed.
The beyond-use-date may be placed on the prescription label or on a flag label
attached to the bottle. A beyond-use-date is not required on the label of a
prescription dispensed to a person at the time of release from prison or jail
if the prescription is for not more than a 10-day supply of medication;
and
(III) for each drug product
sets forth the directions for use and cautionary statements, if any, contained
on the prescription drug order or required by law.
(3) Labeling. The
patient med-pak shall be accompanied by a patient package insert, in the event
that any drug contained therein is required to be dispensed with such insert as
accompanying labeling. Alternatively, such required information may be
incorporated into a single, overall educational insert provided by the
pharmacist for the total patient med-pak.
(4) Packaging. In the absence of more
stringent packaging requirements for any of the drug products contained
therein, each container of the patient med-pak shall comply with official
packaging standards. Each container shall be either not reclosable or so
designed as to show evidence of having been opened.
(5) Guidelines. It is the responsibility of
the dispensing pharmacist when preparing a patient med-pak, to take into
account any applicable compendial requirements or guidelines and the physical
and chemical compatibility of the dosage forms placed within each container, as
well as any therapeutic incompatibilities that may attend the simultaneous
administration of the drugs.
(6)
Recordkeeping. In addition to any individual prescription filing requirements,
a record of each patient med-pak shall be made and filed. Each record shall
contain, as a minimum:
(A) the name and
address of the patient;
(B) the
unique identification number for the patient med-pak itself and a separate
unique identification number for each of the prescription drug orders for each
of the drug products contained therein;
(C) the name of the manufacturer or
distributor and lot number for each drug product contained therein;
(D) information identifying or describing the
design, characteristics, or specifications of the patient med-pak sufficient to
allow subsequent preparation of an identical patient med-pak for the
patient;
(E) the date of
preparation of the patient med-pak and the beyond-use date that was
assigned;
(F) any special labeling
instructions; and
(G) the initials
or an identification code of the dispensing pharmacist.
(7) The patient med-pak label is not required
to include the initials or identification code of the dispensing pharmacist as
specified in paragraph (2)(A) of this subsection if the identity of the
dispensing pharmacist is recorded in the pharmacy's data processing system. The
record of the identity of the dispensing pharmacist shall not be altered in the
pharmacy's data processing system.
(i) Automated devices and systems in a
pharmacy.
(1) Automated counting devices. If a
pharmacy uses automated counting devices:
(A)
the pharmacy shall have a method to calibrate and verify the accuracy of the
automated counting device and document the calibration and verification on a
routine basis;
(B) the devices may
be loaded with bulk drugs only by a pharmacist or by pharmacy technicians or
pharmacy technician trainees under the direction and direct supervision of a
pharmacist;
(C) the label of an
automated counting device container containing a bulk drug shall indicate the
brand name and strength of the drug; or if no brand name, then the generic
name, strength, and name of the manufacturer or distributor;
(D) records of loading bulk drugs into an
automated counting device shall be maintained to show:
(i) name of the drug, strength, and dosage
form;
(ii) manufacturer or
distributor;
(iii) manufacturer's
lot number;
(iv) expiration
date;
(v) date of
loading;
(vi) name, initials, or
electronic signature of the person loading the automated counting device;
and
(vii) name, initials, or
electronic signature of the responsible pharmacist; and
(E) the automated counting device shall not
be used until a pharmacist verifies that the system is properly loaded and
affixes his or her name, initials, or electronic signature to the record as
specified in subparagraph (D) of this paragraph.
(2) Automated pharmacy dispensing systems.
(A) Authority to use automated pharmacy
dispensing systems. A pharmacy may use an automated pharmacy dispensing system
to fill prescription drug orders provided that:
(i) the pharmacist-in-charge is responsible
for the supervision of the operation of the system;
(ii) the automated pharmacy dispensing system
has been tested by the pharmacy and found to dispense accurately. The pharmacy
shall make the results of such testing available to the board upon request;
and
(iii) the pharmacy will make
the automated pharmacy dispensing system available for inspection by the board
for the purpose of validating the accuracy of the system.
(B) Automated pharmacy dispensing systems may
be stocked or loaded by a pharmacist or by a pharmacy technician or pharmacy
technician trainee under the supervision of a pharmacist.
(C) Quality assurance program. A pharmacy
which uses an automated pharmacy dispensing system to fill prescription drug
orders shall operate according to a quality assurance program of the automated
pharmacy dispensing system which:
(i) requires
continuous monitoring of the automated pharmacy dispensing system;
and
(ii) establishes mechanisms and
procedures to test the accuracy of the automated pharmacy dispensing system at
least every twelve months and whenever any upgrade or change is made to the
system and documents each such activity.
(D) Policies and procedures of operation.
(i) When an automated pharmacy dispensing
system is used to fill prescription drug orders, it shall be operated according
to written policies and procedures of operation. The policies and procedures of
operation shall:
(I) provide for a
pharmacist's review, approval, and accountability for the transmission of each
original or new prescription drug order to the automated pharmacy dispensing
system before the transmission is made;
(II) provide for access to the automated
pharmacy dispensing system for stocking and retrieval of medications which is
limited to licensed healthcare professionals or pharmacy technicians acting
under the supervision of a pharmacist;
(III) require that a pharmacist checks,
verifies, and documents that the correct medication and strength of bulk drugs,
prepackaged containers, or manufacturer's unit of use packages were properly
stocked, filled, and loaded in the automated pharmacy dispensing system prior
to initiating the fill process; alternatively, an electronic verification
system may be used for verification of manufacturer's unit of use packages or
prepacked medication previously verified by a pharmacist;
(IV) provide for an accountability record to
be maintained that documents all transactions relative to stocking and removing
medications from the automated pharmacy dispensing system;
(V) require a prospective drug regimen review
is conducted as specified in subsection (c)(2) of this section; and
(VI) establish and make provisions for
documentation of a preventative maintenance program for the automated pharmacy
dispensing system.
(ii)
A pharmacy that uses an automated pharmacy dispensing system to fill
prescription drug orders shall, at least annually, review its written policies
and procedures, revise them if necessary, and document the review.
(E) Recovery Plan. A pharmacy that
uses an automated pharmacy dispensing system to fill prescription drug orders
shall maintain a written plan for recovery from a disaster or any other
situation which interrupts the ability of the automated pharmacy dispensing
system to provide services necessary for the operation of the pharmacy. The
written plan for recovery shall include:
(i)
planning and preparation for maintaining pharmacy services when an automated
pharmacy dispensing system is experiencing downtime;
(ii) procedures for response when an
automated pharmacy dispensing system is experiencing downtime; and
(iii) procedures for the maintenance and
testing of the written plan for recovery.
(F) Final check of prescriptions dispensed
using an automated pharmacy dispensing system. For the purpose of §
291.32(c)(2)(D)
of this title (relating to Personnel), a pharmacist must perform the final
check of all prescriptions prior to delivery to the patient to ensure that the
prescription is dispensed accurately as prescribed.
(i) This final check shall be considered
accomplished if:
(I) a check of the final
product is conducted by a pharmacist after the automated pharmacy dispensing
system has completed the prescription and prior to delivery to the patient;
or
(II) the following checks are
conducted:
(-a-) if the automated pharmacy
dispensing system contains bulk stock drugs, a pharmacist verifies that those
drugs have been accurately stocked as specified in subparagraph (D)(i)(III) of
this paragraph;
(-b-) if the
automated pharmacy dispensing system contains manufacturer's unit of use
packages or prepackaged medication previously verified by a pharmacist, an
electronic verification system has confirmed that the medications have been
accurately stocked as specified in subparagraph (D)(i)(III) of this
paragraph;
(-c-) a pharmacist checks
the accuracy of the data entry of each original or new prescription drug order
entered into the automated pharmacy dispensing system; and
(-d-) an electronic verification process is
used to verify the proper prescription label has been affixed to the correct
medication container, prepackaged medication or manufacturer unit of use
package for the correct patient.
(ii) If the final check is accomplished as
specified in clause (i)(II) of this subparagraph, the following additional
requirements must be met:
(I) the dispensing
process must be fully automated from the time the pharmacist releases the
prescription to the automated pharmacy dispensing system until a completed,
labeled prescription ready for delivery to the patient is produced;
(II) the pharmacy has conducted initial
testing and has a continuous quality assurance program which documents that the
automated pharmacy dispensing system dispenses accurately as specified in
subparagraph (C) of this paragraph;
(III) the automated pharmacy dispensing
system documents and maintains:
(-a-) the
name(s), initials, or identification code(s) of each pharmacist responsible for
the checks outlined in clause (i)(II) of this subparagraph; and
(-b-) the name(s), initials, or
identification code(s) and specific activity(ies) of each pharmacist, pharmacy
technician, or pharmacy technician trainee who performs any other portion of
the dispensing process; and
(IV) the pharmacy establishes mechanisms and
procedures to test the accuracy of the automated pharmacy dispensing system at
least every month rather than every twelve months as specified in subparagraph
(C) of this paragraph.
(3) Automated checking device.
(A) For the purpose of §
291.32(c)(2)(D)
of this title, the final check of a dispensed prescription shall be considered
accomplished using an automated checking device provided a check of the final
product is conducted by a pharmacist prior to delivery to the patient or the
following checks are performed:
(i) the drug
used to fill the order is checked through the use of an automated checking
device which verifies that the drug is labeled and packaged accurately;
and
(ii) a pharmacist checks the
accuracy of each original or new prescription drug order and is responsible for
the final check of the order through the automated checking device.
(B) If the final check is
accomplished as specified in subparagraph (A) of this paragraph, the following
additional requirements must be met:
(i) the
pharmacy has conducted initial testing of the automated checking device and has
a continuous quality assurance program which documents that the automated
checking device accurately confirms that the correct drug and strength has been
labeled with the correct label for the correct patient;
(ii) the pharmacy documents and maintains:
(I) the name(s), initials, or identification
code(s) of each pharmacist responsible for the checks outlined in subparagraph
(A)(i) of this paragraph; and
(II)
the name(s) initials, or identification code(s) and specific activity(ies) of
each pharmacist, pharmacy technician, or pharmacy technician trainee who
performs any other portion of the dispensing process;
(iii) the pharmacy establishes mechanisms and
procedures to test the accuracy of the automated checking device at least
monthly; and
(iv) the pharmacy
establishes procedures to ensure that errors identified by the automated
checking device may not be overridden by a pharmacy technician and must be
reviewed and corrected by a pharmacist.
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.
No prior version found.