Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,920
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(i) soap or detergent; and
(ii) air-driers or single-use towels.
(D) If drug products which require special precau-
tions 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 con-
taminated 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 oper-
ated within designed operational limits;
(ii) of suitable composition so that surfaces that con-
tact components, in-process material, or drug products shall not be re-
active, additive, or absorptive so as to alter the safety, identity, strength,
quality, or purity of the drug product beyond the desired result;
(iii) cleaned and sanitized immediately prior and af-
ter 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 com-
pounded 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 deter-
mined 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 in-
gredients;
(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 tempera-
tures.(I) Nonaqueous liquids and solid formulations
(Where the manufactured drug product is the source of active ingre-
dient): 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 refriger-
ated 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 com-
pounded preparation.
(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 in-
dicates that the preparation was compounded by the pharmacy must
be included in this written information. If there is no written infor-
mation 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
compounding.
(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 cate-
gories:
(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 ingre-
dients 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 prod-
uct.37 TexReg 6920 August 31, 2012 Texas Register
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/101/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.