| (ii) air-driers or single-use towels.
(D) If drug products which require special precautions
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 contaminated equipment
prior to its use for the preparation of other drug products, must
be used in order to prevent cross-contamination.
(E) Cleaning and sanitizing of surfaces in the non-sterile
compounding area(s) shall occur on a regular basis as defined in appropriate
SOPs as outlined in paragraph (8)(A) of this subsection.
(4) Equipment and Supplies. The pharmacy shall:
(A) if the pharmacy engages in compounding non-sterile
preparations that require weighing a component of the preparation,
have a Class A prescription balance, or analytical balance and weights
which shall be calibrated and have the accuracy of the balance verified
by the pharmacy at least every 12 months as specified in the pharmacy's
SOPs. The pharmacy shall document the calibration and verification;
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 operated
within designed operational limits;
(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 to and
after 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
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.
Cont'd... |
