| (B) obtain continuing education appropriate for the
type of compounding done by the pharmacy technician or pharmacy technician
trainee; and
(C) perform compounding duties under the direct supervision
of and responsible to a pharmacist.
(5) Training.
(A) All training activities shall be documented and
covered by appropriate SOPs as outlined in subsection (d)(8)(A) of
this section.
(B) All personnel involved in non-sterile compounding
shall be well trained and must participate in continuing relevant
training programs.
(C) Training shall include instruction, experience,
and demonstrated proficiency in the following areas:
(i) hand hygiene;
(ii) garbing;
(iii) cleaning and sanitizing;
(iv) handling and transporting components and compounded
non-sterile preparations;
(v) measuring and mixing;
(vi) proper use of equipment and devices selected to
compound non-sterile preparations; and
(vii) documentation of the compounding process (e.g.,
Master Formulation Records and Compounding Records).
(d) Operational Standards.
(1) General requirements.
(A) Non-sterile drug preparations may be compounded
in licensed pharmacies:
(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) Non-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 (5)(C) 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 (5)(C)
of this subsection; and
(IV) quantity or amount in the container.
(C) Commercially available products may be compounded
for dispensing to individual patients provided the following conditions
are met:
(i) the commercial product is not reasonably available
from normal distribution channels in a timely manner to meet 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 patient needs 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 product
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/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 non-sterile prescription compounding
services, which may include specific drug products 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) A pharmacist may add flavoring to a prescription
at the request of a patient, the patient's agent, or the prescriber.
The pharmacist shall label the flavored prescription with a beyond-use-date
that shall be no longer than fourteen days if stored in a refrigerator
unless otherwise documented. Documentation of beyond-use-dates longer
than fourteen days shall be maintained by the pharmacy electronically
or manually and made available to agents of the board on request.
A pharmacist may not add flavoring to an over-the-counter product
at the request of a patient or patient's agent unless the pharmacist
obtains a prescription for the over-the-counter product from the patient's
practitioner.
(2) Library. In addition to the library requirements
of the pharmacy's specific license classification, a pharmacy shall
maintain a current copy, in hard-copy or electronic format, of Chapter
795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.
(3) Environment.
(A) Pharmacies engaging in compounding shall have a
designated and adequate area for the safe and orderly compounding
of non-sterile preparations, including the placement of equipment
and materials.
(B) Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C) A sink with hot and cold running water, exclusive
of rest room facilities, shall be accessible to the compounding areas
and be maintained in a sanitary condition. Supplies necessary for
adequate washing shall be accessible in the immediate area of the
sink and include:
(i) soap or detergent; and
(ii) air-driers or single-use towels.
(D) Appropriate measures shall be used to prevent cross-contamination
between compounding non-sterile preparations, including dedication
of equipment for such operations or the meticulous cleaning of contaminated
equipment prior to its use for the preparation of subsequent compounds.
(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.
(A) If the pharmacy engages in compounding non-sterile
preparations that require weighing a component of the preparation,
the pharmacy shall 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.
(B) The pharmacy shall 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
Cont'd... |
