| (ii) of suitable composition so that surfaces that
contact components, in-process material, or drug products shall not
be reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the drug product beyond the desired
(iii) cleaned and sanitized immediately prior and after
to each use; and
(iv) routinely inspected, calibrated (if necessary),
or checked to ensure proper performance.
(5) Labeling. In addition to the labeling requirements
of the pharmacy's specific license classification, the label dispensed
or distributed pursuant to a prescription drug or medication order
shall contain the following.
(A) The generic name(s) or the official name(s) of
the principal active ingredient(s) of the compounded preparation.
(B) A statement that the preparation has been compounded
by the pharmacy. (An auxiliary label may be used on the container
to meet this requirement).
(C) A beyond-use date after which the compounded preparation
should not be used. The beyond-use date shall be determined as outlined
in Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile
Preparations including the following:
(i) The pharmacist shall consider:
(I) physical and chemical properties of active ingredients;
(II) use of preservatives and/or stabilizing agents;
(III) dosage form;
(IV) storage containers and conditions; and
(V) scientific, laboratory, or reference data from
a peer reviewed source and retained in the pharmacy. The reference
data should follow the same preparation instructions for combining
raw materials and packaged in a container with similar properties.
(ii) In the absence of stability information applicable
for a specific drug or preparation, the following maximum beyond-use
dates are to be used when the compounded preparation is packaged in
tight, light-resistant containers and stored at controlled room temperatures.
(I) Nonaqueous liquids and solid formulations (Where
the manufactured drug product is the source of active ingredient):
25% of the time remaining until the product's expiration date or 6
months, whichever is earlier.
(II) Water-containing formulations (Prepared from ingredients
in solid form): Not later than 14 days when refrigerated between 2
- 8 degrees Celsius (36 - 46 degrees Fahrenheit).
(III) All other formulations: Intended duration of
therapy or 30 days, whichever is earlier.
(iii) Beyond-use date limits may be exceeded when supported
by valid scientific stability information for the specific compounded
(6) Written drug information. Written information about
the compounded preparation or its major active ingredient(s) shall
be given to the patient at the time of dispensing. A statement which
indicates that the preparation was compounded by the pharmacy must
be included in this written information. If there is no written information
available, the patient should be advised that the drug has been compounded
and how to contact a pharmacist, and if appropriate the prescriber,
concerning the drug.
(7) Drugs, components, and materials used in non-sterile
(A) Drugs used in non-sterile compounding shall be
a 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 a 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
(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
(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
(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;
(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 wear clean clothing appropriate to the operation being performed.
Protective apparel, such as coats/jackets, aprons, hair nets, gowns,
hand or arm coverings, or masks shall be worn as necessary to protect
personnel from chemical exposure and drug preparations from contamination.
(E) 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
(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
(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.
(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;
(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
(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;
(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.
(i) Master work sheet. A master work sheet shall be
developed and approved by a pharmacist for preparations prepared in
batch. Once approved, a duplicate of the master work sheet shall be
used as the preparation work sheet from which each batch is prepared
and on which all documentation for that batch occurs. The master work
sheet shall contain at a minimum:
(I) the formula;
(II) the components;
(III) the compounding directions;
(IV) a sample label;
(V) evaluation and testing requirements;
(VI) specific equipment used during preparation; and
(VII) storage requirements.
(ii) Preparation work sheet. The preparation work sheet
for each batch of preparations shall document the following:
(I) identity of all solutions and ingredients and their
corresponding amounts, concentrations, or volumes;
(II) lot number or each component;
(III) component manufacturer/distributor or suitable
(IV) container specifications;
(V) unique lot or control number assigned to batch;
(VI) beyond use date of batch-prepared preparations;
(VII) date of preparation;