| (A) Drugs used in non-sterile compounding shall be
USP/NF grade substances manufactured in an FDA-registered facility.
(B) If USP/NF grade substances are not available, or
when food, cosmetics, or other substances are or must be used, the
substance shall be of a chemical grade in one of the following categories:
(i) Chemically Pure (CP);
(ii) Analytical Reagent (AR); or
(iii) American Chemical Society (ACS); or
(iv) Food Chemical Codex; or
(C) If a drug, component, or material is not purchased
from an FDA-registered facility, the pharmacist shall establish purity
and stability by obtaining a Certificate of Analysis from the supplier
and the pharmacist shall compare the monograph of drugs in a similar
class to the Certificate of Analysis.
(D) A manufactured drug product may be a source of
active ingredient. Only manufactured drugs from containers labeled
with a batch control number and a future expiration date are acceptable
as a potential source of active ingredients. When compounding with
manufactured drug products, the pharmacist must consider all ingredients
present in the drug product relative to the intended use of the compounded
preparation.
(E) All components shall be stored in properly labeled
containers in a clean, dry area, under proper temperatures.
(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list of drug products withdrawn or removed from the market for safety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; and
(viii) storage of compounded preparations.
(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 an apparent illness or open lesion
that may adversely affect the safety or quality of a drug product
being compounded shall be excluded from direct contact with components,
drug product containers, closures, any materials involved in the compounding
process, and drug products until the condition is corrected.
(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.
(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 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.
(2) Compounding records.
(A) Compounding pursuant to patient specific prescription
drug or medication orders. Compounding records for all compounded
preparations shall be maintained by the pharmacy electronically or
manually as part of the prescription drug or medication order, formula
record, formula book, or compounding log and shall include:
(i) the date of preparation;
(ii) a complete formula, including methodology and
necessary equipment which includes the brand name(s) of the raw materials,
or if no brand name, the generic name(s) and name(s) of the manufacturer(s)
of the raw materials and the quantities of each;
(iii) signature or initials of the pharmacist or pharmacy
technician or pharmacy technician trainee performing the compounding;
(iv) signature or initials of the pharmacist responsible
for supervising pharmacy technicians or pharmacy technician trainees
and conducting in-process and final checks of compounded preparations
if pharmacy technicians or pharmacy technician trainees perform the
compounding function;
(v) the quantity in units of finished preparations
or amount of raw materials;
(vi) the container used and the number of units prepared;
(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. 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.
(B) Compounding records when batch compounding or compounding
in anticipation of future prescription drug or medication orders.
Cont'd... |
