| (F) Drug product containers and closures shall not
be reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the compounded drug product beyond
the desired result.
(G) Components, drug product containers, and closures
shall be rotated so that the oldest stock is used first.
(H) Container closure systems shall provide adequate
protection against foreseeable external factors in storage and use
that can cause deterioration or contamination of the compounded drug
product.
(I) A pharmacy may not compound a preparation that
contains ingredients appearing on a federal Food and Drug Administration
list of drug products withdrawn or removed from the market for safety
reasons.
(8) Compounding process.
(A) All significant procedures performed in the compounding
area shall be covered by written SOPs designed to ensure accountability,
accuracy, quality, safety, and uniformity in the compounding process.
At a minimum, SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging;
(viii) storage of compounded preparations;
(ix) hand hygiene and garbing; and
(x) cleaning and sanitizing.
(B) Any compounded preparation with an official monograph
in the USP/NF shall be compounded, labeled, and packaged in conformity
with the USP/NF monograph for the drug.
(C) Any person with a communicable illness or open
lesion that may adversely affect the safety or quality of a drug product
being compounded shall report these conditions to the designated person(s).
The designated person(s) shall determine whether the person must be
excluded from compounding areas until the person's conditions have
resolved.
(D) Personnel engaged in the compounding of drug preparations
shall perform proper hand hygiene prior to engaging in compounding
activities. Proper hand hygiene shall be defined in appropriate SOPs
as outlined in subparagraph (A) of this paragraph and appropriate
for prevention of preparation and facility contamination.
(E) Garbing requirements and the frequency of changing
garb shall be determined by the pharmacy and documented in appropriate
SOPs as outlined in subparagraph (A) of this paragraph. The garbing
requirements under the pharmacy's SOPs must be appropriate for the
type of compounding performed. Gloves shall be worn for the prevention
of preparation and facility contamination.
(F) At each step of the compounding process, the pharmacist
shall ensure that components used in compounding are accurately weighed,
measured, or subdivided as appropriate to conform to the formula being
prepared.
(9) Quality Assurance.
(A) Initial formula validation. Prior to routine compounding
of a non-sterile preparation, a pharmacy shall conduct an evaluation
that shows that the pharmacy is capable of compounding a product that
contains the stated amount of active ingredient(s).
(B) Finished preparation checks. The prescription drug
and medication orders, written compounding procedure, preparation
records, and expended materials used to make compounded non-sterile
preparations shall be inspected for accuracy of correct identities
and amounts of ingredients, packaging, labeling, and expected physical
appearance and properties before the non-sterile preparations are
dispensed.
(10) Quality Control.
(A) The pharmacy shall follow established quality control
procedures to monitor the quality of compounded drug preparations
for uniformity and consistency such as capsule weight variations,
adequacy of mixing, clarity, or pH of solutions. When developing these
procedures, pharmacy personnel shall consider the provisions of Chapter
795, concerning Pharmacy Compounding Non-Sterile Preparations, Chapter
1075, concerning Good Compounding Practices, and Chapter 1160, concerning
Pharmaceutical Calculations in Prescription Compounding contained
in the current USP/NF. Such procedures shall be documented and be
available for inspection.
(B) Compounding procedures that are routinely performed,
including batch compounding, shall be completed and verified according
to written procedures. The act of verification of a compounding procedure
involves checking to ensure that calculations, weighing and measuring,
order of mixing, and compounding techniques were appropriate and accurately
performed.
(C) Unless otherwise indicated or appropriate, compounded
preparations are to be prepared to ensure that each preparation shall
contain not less than 90.0 percent and not more than 110.0 percent
of the theoretically calculated and labeled quantity of active ingredient
per unit weight or volume and not less than 90.0 percent and not more
than 110.0 percent of the theoretically calculated weight or volume
per unit of the preparation.
(e) Records.
(1) Maintenance of records. Every record required by
this section shall be:
(A) kept by the pharmacy and be available, for at least
two years, for inspecting and copying by the board or its representative
and to other authorized local, state, or federal law enforcement agencies;
and
(B) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the Texas State Board of Pharmacy. If the
pharmacy maintains the records in an electronic format, the requested
records must be provided in an electronic format. Failure to provide
the records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records
in violation of the Act.
(C) Documentation of the performance of quality control
procedures is not required if the compounding process is done pursuant
to a patient specific order and involves the mixing of two or more
commercially available oral liquids or commercially available preparations
when the final product is intended for external use.
(2) Master Formulation Record and Compounding Record.
(A) Master Formulation Record. A master formulation
record shall be developed and approved by a pharmacist for all compounded
preparations. Once approved, a duplicate of the master formulation
record shall be used as the compound record each time the compound
is prepared and on which all documentation for that compound occurs.
The master formulation record shall contain at a minimum:
(i) the formula;
(ii) the components;
(iii) the compounding directions;
(iv) evaluation and testing requirements;
(v) specific equipment used during preparation;
(vi) storage requirements;
(vii) a reference to the location of the following
documentation which may be maintained with other records, such as
quality control records:
(I) the criteria used to determine the beyond-use date;
and
(II) documentation of performance of quality control
procedures, including, but not limited to, expected physical appearance
of the final product.
(B) Compounding Record. The record for each preparation
shall document the following:
(i) identity of all components and their corresponding
amounts, concentrations, or volumes;
(ii) lot number and expiration date of each component;
(iii) component manufacturer/distributor or suitable
identifying number;
(iv) container specifications;
(v) unique lot or control number;
(vi) beyond use date;
(vii) date of preparation;
(viii) name, initials, or electronic signature of the
person(s) involved in the preparation;
(ix) name, initials, or electronic signature of the
responsible pharmacist;
(x) finished preparation evaluation and testing specifications,
if applicable; and
(xi) comparison of actual yield to anticipated or theoretical
yield, when appropriate.
(f) Office Use Compounding and Distribution of Compounded
Preparations to Class C Pharmacies or Veterinarians in Accordance
With §563.054 of the Act.
(1) General.
(A) A pharmacy may dispense and deliver a reasonable
quantity of a compounded preparation to a practitioner for office
use by the practitioner in accordance with this subsection.
(B) A Class A pharmacy is not required to register
or be licensed under Chapter 431, Health and Safety Code, to distribute
non-sterile compounded preparations to a Class C pharmacy.
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