(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) pharmacy 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) Cleaning--The process of removing soil (e.g., organic
and inorganic material) from objects and surfaces, normally accomplished
by manually or mechanically using water with detergents or enzymatic
products.
(3) Component--Any ingredient intended for use in the
compounding of a drug preparation, including those that may not appear
in such preparation.
(4) 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.
(5) Hot water--The temperature of water from the pharmacy's
sink maintained at a minimum of 105 degrees F (41 degrees C).
(6) 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.
(7) Sanitizing--A process for reducing on inanimate
surfaces the number of all forms of microbial life including fungi,
viruses, and bacteria using an appropriate agent.
(8) SOPs--Standard operating procedures.
(9) 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.
(C) Training shall include instruction, experience,
and demonstrated proficiency in the following areas:
(i) hand hygiene;
(ii) garbing;
(iii) cleaning and sanitizing;
(iv) handling and transporting components and compounded
non-sterile preparations;
(v) measuring and mixing;
(vi) proper use of equipment and devices selected to
compound non-sterile preparations; and
(vii) documentation of the compounding process (e.g.,
Master Formulation Records and Compounding Records).
(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;
Cont'd... |