| (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
result;
(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
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
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
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 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
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 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
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.
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