| (38) Product--A commercially manufactured sterile drug
or nutrient that has been evaluated for safety and efficacy by the
U.S. Food and Drug Administration (FDA). Products are accompanied
by full prescribing information, which is commonly known as the FDA-approved
manufacturer's labeling or product package insert.
(39) Positive Control--A quality assurance sample prepared
to test positive for microbial growth.
(40) Quality assurance--The set of activities used
to ensure that the process used in the preparation of sterile drug
preparations lead to preparations that meet predetermined standards
of quality.
(41) Quality control--The set of testing activities
used to determine that the ingredients, components (e.g., containers),
and final compounded sterile preparations prepared meet predetermined
requirements with respect to identity, purity, non-pyrogenicity, and
sterility.
(42) Reasonable quantity--An amount of a compounded
drug that:
(A) does not exceed the amount a practitioner anticipates
may be used in the practitioner's office or facility before the beyond
use date of the drug;
(B) is reasonable considering the intended use of the
compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a
whole, is not greater than an amount the pharmacy is capable of compounding
in compliance with pharmaceutical standards for identity, strength,
quality, and purity of the compounded drug that are consistent with
United States Pharmacopoeia guidelines and accreditation practices.
(43) Segregated Compounding Area--A designated space,
either a demarcated area or room, that is restricted to preparing
low-risk level compounded sterile preparations with 12-hour or less
beyond-use date. Such area shall contain a device that provides unidirectional
airflow of ISO Class 5 air quality for preparation of compounded sterile
preparations and shall be void of activities and materials that are
extraneous to sterile compounding.
(44) Single-dose container--A single-unit container
for articles or preparations intended for parenteral administration
only. It is intended for a single use. A single-dose container is
labeled as such. Examples of single-dose containers include pre-filled
syringes, cartridges, fusion-sealed containers, and closure-sealed
containers when so labeled.
(45) SOPs--Standard operating procedures.
(46) Sterilizing Grade Membranes--Membranes that are
documented to retain 100% of a culture of 107 microorganisms of a
strain of Brevundimonas (Pseudomonas) diminuta per square centimeter
of membrane surface under a pressure of not less than 30 psi (2.0
bar). Such filter membranes are nominally at 0.22-micrometer or 0.2-micrometer
nominal pore size, depending on the manufacturer's practice.
(47) Sterilization by Filtration--Passage of a fluid
or solution through a sterilizing grade membrane to produce a sterile
effluent.
(48) Terminal Sterilization--The application of a lethal
process, e.g., steam under pressure or autoclaving, to sealed final
preparation containers for the purpose of achieving a predetermined
sterility assurance level of usually less than 10-6 or a probability
of less than one in one million of a non-sterile unit.
(49) Unidirectional Flow--An airflow moving in a single
direction in a robust and uniform manner and at sufficient speed to
reproducibly sweep particles away from the critical processing or
testing area.
(50) USP/NF--The current edition of the United States
Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. The pharmacy shall have a pharmacist-in-charge
in compliance with the specific license classification of the pharmacy.
(B) Responsibilities. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall
have the responsibility for, at a minimum, the following concerning
the compounding of sterile preparations:
(i) developing a system to ensure that all pharmacy
personnel responsible for compounding and/or supervising the compounding
of sterile preparations within the pharmacy receive appropriate education
and training and competency evaluation;
(ii) determining that all personnel involved in compounding
sterile preparations obtain continuing education appropriate for the
type of compounding done by the personnel;
(iii) supervising a system to ensure appropriate procurement
of drugs and devices and storage of all pharmaceutical materials including
pharmaceuticals, components used in the compounding of sterile preparations,
and drug delivery devices;
(iv) ensuring that the equipment used in compounding
is properly maintained;
(v) developing a system for the disposal and distribution
of drugs from the pharmacy;
(vi) developing a system for bulk compounding or batch
preparation of drugs;
(vii) developing a system for the compounding, sterility
assurance, quality assurance, and quality control of sterile preparations;
and
(viii) if applicable, ensuring that the pharmacy has
a system to dispose of hazardous waste in a manner so as not to endanger
the public health.
(2) Pharmacists.
(A) General.
(i) A pharmacist is responsible for ensuring that compounded
sterile preparations are accurately identified, measured, diluted,
and mixed and are correctly purified, sterilized, packaged, sealed,
labeled, stored, dispensed, and distributed.
(ii) A pharmacist shall inspect and approve all components,
drug preparation containers, closures, labeling, and any other materials
involved in the compounding process.
(iii) A pharmacist shall review all compounding records
for accuracy and conduct periodic in-process checks as defined in
the pharmacy's policy and procedures.
(iv) A pharmacist shall review all compounding records
for accuracy and conduct a final check.
(v) A pharmacist is responsible for ensuring the proper
maintenance, cleanliness, and use of all equipment used in the compounding
process.
(vi) A pharmacist shall be accessible at all times,
24 hours a day, to respond to patients' and other health professionals'
questions and needs.
(B) Initial training and continuing education.
(i) All pharmacists who compound sterile preparations
or supervise pharmacy technicians and pharmacy technician trainees
compounding sterile preparations shall comply with the following:
(I) complete through a single course, a minimum of
20 hours of instruction and experience in the areas listed in paragraph
(4)(D) of this subsection. Such training shall be obtained through
completion of a recognized course in an accredited college of pharmacy
or a course sponsored by an ACPE accredited provider;
(II) complete a structured on-the-job didactic and
experiential training program at this pharmacy which provides sufficient
hours of instruction and experience in the facility's sterile compounding
processes and procedures. Such training may not be transferred to
another pharmacy unless the pharmacies are under common ownership
and control and use a common training program; and
(III) possess knowledge about:
(-a-) aseptic processing;
(-b-) quality control and quality assurance as related
to environmental, component, and finished preparation release checks
and tests;
(-c-) chemical, pharmaceutical, and clinical properties
of drugs;
(-d-) container, equipment, and closure system selection;
and
(-e-) sterilization techniques.
(ii) The required experiential portion of the training
programs specified in this subparagraph must be supervised by an individual
who is actively engaged in performing sterile compounding and is qualified
and has completed training as specified in this paragraph or paragraph
(3) of this subsection.
(iii) In order to renew a license to practice pharmacy,
during the previous licensure period, a pharmacist engaged in sterile
compounding shall complete a minimum of:
(I) two hours of ACPE-accredited continuing education
relating to one or more of the areas listed in paragraph (4)(D) of
this subsection if the pharmacist is engaged in compounding low and
medium risk sterile preparations; or
(II) four hours of ACPE-accredited continuing education
relating to one or more of the areas listed in paragraph (4)(D) of
this subsection if the pharmacist is engaged in compounding high risk
sterile preparations.
(3) Pharmacy technicians and pharmacy technician trainees.
Cont'd... |
