| (a) Purpose. Pharmacies compounding non-sterile preparations,
prepackaging pharmaceutical products and distributing those products
shall comply with all requirements for their specific license classification
and this section. The purpose of this section is to provide standards
for the:
(1) compounding of non-sterile preparations pursuant
to a prescription or medication order for a patient from a practitioner
in Class A (Community), Class C (Institutional), and Class E (Non-resident)
pharmacies;
(2) compounding, dispensing, and delivery of a reasonable
quantity of a compounded non-sterile preparation in a Class A (Community),
Class C (Institutional), and Class E (Non-resident) pharmacies to
a practitioner's office for office use by the practitioner;
(3) compounding and distribution of compounded non-sterile
preparations by a Class A (Community) pharmacy for a Class C (Institutional)
pharmacy; and
(4) compounding of non-sterile preparations by a Class
C (Institutional) pharmacy and the distribution of the compounded
preparations to other Class C (Institutional) pharmacies under common
ownership.
(b) Definitions. In addition to the definitions for
specific license classifications, the following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise.
(1) Beyond-use date--The date or time after which the
compounded non-sterile preparation shall not be stored or transported
or begin to be administered to a patient. The beyond-use date is determined
from the date or time when the preparation was compounded.
(2) Component--Any ingredient intended for use in the
compounding of a drug preparation, including those that may not appear
in such preparation.
(3) Compounding--The preparation, mixing, assembling,
packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription
drug or medication order, based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(B) for administration to a patient by a practitioner
as the result of a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C) in anticipation of prescription drug or medication
orders based on routine, regularly observed prescribing patterns;
or
(D) for or as an incident to research, teaching, or
chemical analysis and not for sale or dispensing, except as allowed
under §562.154 or Chapter 563 of the Occupations Code.
(4) Hot water--The temperature of water from the pharmacy's
sink maintained at a minimum of 105 degrees F (41 degrees C).
(5) Reasonable quantity--An amount of a compounded
drug that:
(A) does not exceed the amount a practitioner anticipates
may be used in the practitioner's office or facility before the beyond
use date of the drug;
(B) is reasonable considering the intended use of the
compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a
whole, is not greater than an amount the pharmacy is capable of compounding
in compliance with pharmaceutical standards for identity, strength,
quality, and purity of the compounded drug that are consistent with
United States Pharmacopoeia guidelines and accreditation practices.
(6) SOPs--Standard operating procedures.
(7) USP/NF--The current edition of the United States
Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall
have the responsibility for, at a minimum, the following concerning
non-sterile compounding:
(A) determining that all personnel involved in non-sterile
compounding possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
(B) determining that all personnel involved in non-sterile
compounding obtain continuing education appropriate for the type of
compounding done by the personnel;
(C) assuring that the equipment used in compounding
is properly maintained;
(D) maintaining an appropriate environment in areas
where non-sterile compounding occurs; and
(E) assuring that effective quality control procedures
are developed and followed.
(2) Pharmacists. Special requirements for non-sterile
compounding.
(A) All pharmacists engaged in compounding shall:
(i) possess the education, training, and proficiency
necessary to properly and safely perform compounding duties undertaken
or supervised; and
(ii) obtain continuing education appropriate for the
type of compounding done by the pharmacist.
(B) A pharmacist shall inspect and approve all components,
drug product containers, closures, labeling, and any other materials
involved in the compounding process.
(C) A pharmacist shall review all compounding records
for accuracy and conduct in-process and final checks to ensure that
errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(3) Pharmacy technicians and pharmacy technician trainees.
All pharmacy technicians and pharmacy technician trainees engaged
in non-sterile compounding shall:
(A) possess the education, training, and proficiency
necessary to properly and safely perform compounding duties undertaken;
(B) obtain continuing education appropriate for the
type of compounding done by the pharmacy technician or pharmacy technician
trainee; and
(C) perform compounding duties under the direct supervision
of and responsible to a pharmacist.
(4) Training.
(A) All training activities shall be documented and
covered by appropriate SOPs as outlined in subsection (d)(8)(A) of
this section.
(B) All personnel involved in non-sterile compounding
shall be well trained and must participate in continuing relevant
training programs.
(d) Operational Standards.
(1) General requirements.
(A) Non-sterile drug preparations may be compounded
in licensed pharmacies:
(i) upon presentation of a practitioner's prescription
drug or medication order based on a valid pharmacist/patient/prescriber
relationship;
(ii) in anticipation of future prescription drug or
medication orders based on routine, regularly observed prescribing
patterns; or
(iii) in reasonable quantities for office use by a
practitioner and for use by a veterinarian.
(B) Non-sterile compounding in anticipation of future
prescription drug or medication orders must be based upon a history
of receiving valid prescriptions issued within an established pharmacist/patient/prescriber
relationship, provided that in the pharmacist's professional judgment
the quantity prepared is stable for the anticipated shelf time.
(i) The pharmacist's professional judgment shall be
based on the criteria used to determine a beyond-use date outlined
in paragraph (5)(C) of this subsection.
(ii) Documentation of the criteria used to determine
the stability for the anticipated shelf time must be maintained and
be available for inspection.
(iii) Any preparation compounded in anticipation of
future prescription drug or medication orders shall be labeled. Such
label shall contain:
(I) name and strength of the compounded preparation
or list of the active ingredients and strengths;
(II) facility's lot number;
(III) beyond-use date as determined by the pharmacist
using appropriate documented criteria as outlined in paragraph (5)(C)
of this subsection; and
(IV) quantity or amount in the container.
(C) Commercially available products may be compounded
for dispensing to individual patients provided the following conditions
are met:
(i) the commercial product is not reasonably available
from normal distribution channels in a timely manner to meet patient's
needs;
(ii) the pharmacy maintains documentation that the
product is not reasonably available due to a drug shortage or unavailability
from the manufacturer; and
(iii) the prescribing practitioner has requested that
the drug be compounded as described in subparagraph (D) of this paragraph.
(D) A pharmacy may not compound preparations that are
essentially copies of commercially available products (e.g., the preparation
is dispensed in a strength that is only slightly different from a
commercially available product) unless the prescribing practitioner
specifically orders the strength or dosage form and specifies why
the patient needs the particular strength or dosage form of the preparation.
The prescribing practitioner shall provide documentation of a patient
specific medical need and the preparation produces a clinically significant
therapeutic response (e.g. the physician requests an alternate product
due to hypersensitivity to excipients or preservative in the FDA-approved
product, or the physician requests an effective alternate dosage form)
or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The
methodology for documenting unavailability includes maintaining a
copy of the wholesaler's notification showing back-ordered, discontinued,
or out-of-stock items. This documentation must be available in hard-copy
or electronic format for inspection by the board.
(E) A pharmacy may enter into an agreement to compound
and dispense prescription/medication orders for another pharmacy provided
the pharmacy complies with the provisions of §291.125 of this
title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may advertise
and promote the fact that they provide non-sterile prescription compounding
services, which may include specific drug products and classes of
drugs.
(G) A pharmacy may not compound veterinary preparations
for use in food producing animals except in accordance with federal
guidelines.
(H) A pharmacist may add flavoring to a prescription
at the request of a patient, the patient's agent, or the prescriber.
The pharmacist shall label the flavored prescription with a beyond-use-date
that shall be no longer than fourteen days if stored in a refrigerator
unless otherwise documented. Documentation of beyond-use-dates longer
than fourteen days shall be maintained by the pharmacy electronically
or manually and made available to agents of the board on request.
A pharmacist may not add flavoring to an over-the-counter product
at the request of a patient or patient's agent unless the pharmacist
obtains a prescription for the over-the-counter product from the patient's
practitioner.
(2) Library. In addition to the library requirements
of the pharmacy's specific license classification, a pharmacy shall
maintain a current copy, in hard-copy or electronic format, of Chapter
795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.
(3) Environment.
(A) Pharmacies regularly engaging in compounding shall
have a designated and adequate area for the safe and orderly compounding
of non-sterile preparations, including the placement of equipment
and materials. Pharmacies involved in occasional compounding shall
prepare an area prior to each compounding activity which is adequate
for safe and orderly compounding.
(B) Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C) A sink with hot and cold running water, exclusive
of rest room facilities, shall be accessible to the compounding areas
and be maintained in a sanitary condition. Supplies necessary for
adequate washing shall be accessible in the immediate area of the
sink and include:
(i) soap or detergent; and
(ii) air-driers or single-use towels.
(D) If drug products which require special precautions
to prevent contamination, such as penicillin, are involved in a compounding
operation, appropriate measures, including dedication of equipment
for such operations or the meticulous cleaning of contaminated equipment
prior to its use for the preparation of other drug products, must
be used in order to prevent cross-contamination.
(4) Equipment and Supplies. The pharmacy shall:
(A) have a Class A prescription balance, or analytical
balance and weights which shall be properly maintained and subject
to periodic inspection by the Texas State Board of Pharmacy; and
(B) have equipment and utensils necessary for the proper
compounding of prescription drug or medication orders. Such equipment
and utensils used in the compounding process shall be:
(i) of appropriate design and capacity, and be operated
within designed operational limits;
Cont'd... |
