| (5) Documentation of Training. The pharmacy shall maintain
a record of the training and continuing education on each person who
compounds sterile preparations. The record shall contain, at a minimum,
a written record of initial and in-service training, education, and
the results of written and practical testing and media-fill testing
of pharmacy personnel. The record shall be maintained and available
for inspection by the board and contain the following information:
(A) name of the person receiving the training or completing
the testing or media-fill tests;
(B) date(s) of the training, testing, or media-fill
challenge testing;
(C) general description of the topics covered in the
training or testing or of the process validated;
(D) name of the person supervising the training, testing,
or media-fill challenge testing; and
(E) signature or initials of the person receiving the
training or completing the testing or media-fill challenge testing
and the pharmacist-in-charge or other pharmacist employed by the pharmacy
and designated by the pharmacist-in-charge as responsible for training,
testing, or media-fill challenge testing of personnel.
(d) Operational Standards.
(1) General Requirements.
(A) Sterile preparations may be compounded:
(i) upon presentation of a practitioner's prescription
drug or medication order based on a valid pharmacist/patient/prescriber
relationship;
(ii) in anticipation of future prescription drug or
medication orders based on routine, regularly observed prescribing
patterns; or
(iii) in reasonable quantities for office use by a
practitioner and for use by a veterinarian.
(B) Sterile compounding in anticipation of future prescription
drug or medication orders must be based upon a history of receiving
valid prescriptions issued within an established pharmacist/patient/prescriber
relationship, provided that in the pharmacist's professional judgment
the quantity prepared is stable for the anticipated shelf time.
(i) The pharmacist's professional judgment shall be
based on the criteria used to determine a beyond-use date outlined
in paragraph (6)(G) of this subsection.
(ii) Documentation of the criteria used to determine
the stability for the anticipated shelf time must be maintained and
be available for inspection.
(iii) Any preparation compounded in anticipation of
future prescription drug or medication orders shall be labeled. Such
label shall contain:
(I) name and strength of the compounded preparation
or list of the active ingredients and strengths;
(II) facility's lot number;
(III) beyond-use date as determined by the pharmacist
using appropriate documented criteria as outlined in paragraph (6)(G)
of this subsection;
(IV) quantity or amount in the container;
(V) appropriate ancillary instructions, such as storage
instructions or cautionary statements, including hazardous drug warning
labels where appropriate; and
(VI) device-specific instructions, where appropriate.
(C) Commercially available products may be compounded
for dispensing to individual patients or for office use provided the
following conditions are met:
(i) the commercial product is not reasonably available
from normal distribution channels in a timely manner to meet individual
patient's needs;
(ii) the pharmacy maintains documentation that the
product is not reasonably available due to a drug shortage or unavailability
from the manufacturer; and
(iii) the prescribing practitioner has requested that
the drug be compounded as described in subparagraph (D) of this paragraph.
(D) A pharmacy may not compound preparations that are
essentially copies of commercially available products (e.g., the preparation
is dispensed in a strength that is only slightly different from a
commercially available product) unless the prescribing practitioner
specifically orders the strength or dosage form and specifies why
the individual patient needs the particular strength or dosage form
of the preparation or why the preparation for office use is needed
in the particular strength or dosage form of the preparation. The
prescribing practitioner shall provide documentation of a patient
specific medical need and the preparation produces a clinically significant
therapeutic response (e.g., the physician requests an alternate preparation
due to hypersensitivity to excipients or preservative in the FDA-approved
product, or the physician requests an effective alternate dosage form)
or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The
methodology for documenting unavailability includes maintaining a
copy of the wholesaler's notification showing back-ordered, discontinued,
or out-of-stock items. This documentation must be available in hard-copy
or electronic format for inspection by the board.
(E) A pharmacy may enter into an agreement to compound
and dispense prescription drug or medication orders for another pharmacy
provided the pharmacy complies with the provisions of §291.125
of this title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may advertise
and promote the fact that they provide sterile prescription compounding
services, which may include specific drug preparations and classes
of drugs.
(G) A pharmacy may not compound veterinary preparations
for use in food producing animals except in accordance with federal
guidelines.
(H) Compounded sterile preparations, including hazardous
drugs and radiopharmaceuticals, shall be prepared only under conditions
that protect the pharmacy personnel in the preparation and storage
areas.
(2) Microbial Contamination Risk Levels. Risk Levels
for sterile compounded preparations shall be as outlined in Chapter
797, Pharmacy Compounding--Sterile Preparations of the USP/NF and
as listed in this paragraph.
(A) Low-risk level compounded sterile preparations.
(i) Low-Risk conditions. Low-risk level compounded
sterile preparations are those compounded under all of the following
conditions:
(I) The compounded sterile preparations are compounded
with aseptic manipulations entirely within ISO Class 5 or better air
quality using only sterile ingredients, products, components, and
devices;
(II) The compounding involves only transfer, measuring,
and mixing manipulations using not more than three commercially manufactured
packages of sterile products and not more than two entries into any
one sterile container or package (e.g., bag, vial) of sterile product
or administration container/device to prepare the compounded sterile
preparation;
(III) Manipulations are limited to aseptically opening
ampules, penetrating disinfected stoppers on vials with sterile needles
and syringes, and transferring sterile liquids in sterile syringes
to sterile administration devices, package containers of other sterile
products, and containers for storage and dispensing;
(IV) For a low-risk level preparation, in the absence
of passing a sterility test the storage periods cannot exceed the
following time periods: before administration, the compounded sterile
preparation is stored properly and are exposed for not more than 48
hours at controlled room temperature, for not more than 14 days if
stored at a cold temperature, and for 45 days if stored in a frozen
state between minus 25 degrees Celsius and minus 10 degrees Celsius.
For delayed activation device systems, the storage period begins when
the device is activated.
(ii) Examples of Low-Risk Level Compounding. Examples
of low-risk level compounding include the following:
(I) Single volume transfers of sterile dosage forms
from ampules, bottles, bags, and vials using sterile syringes with
sterile needles, other administration devices, and other sterile containers.
The solution content of ampules shall be passed through a sterile
filter to remove any particles;
(II) Simple aseptic measuring and transferring with
not more than three packages of manufactured sterile products, including
an infusion or diluent solution to compound drug admixtures and nutritional
solutions.
(B) Low-Risk Level compounded sterile preparations
with 12-hour or less beyond-use date. Low-risk level compounded sterile
preparations are those compounded pursuant to a physician's order
for a specific patient under all of the following conditions:
(i) The compounded sterile preparations are compounded
in compounding aseptic isolator or compounding aseptic containment
isolator that does not meet the requirements described in paragraph
(7)(C) or (D) of this subsection (relating to Primary Engineering
Control Device) or the compounded sterile preparations are compounded
in laminar airflow workbench or a biological safety cabinet that cannot
be located within the buffer area;
Cont'd... |
