| (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.
(A) General. All pharmacy technicians and pharmacy
technician trainees shall meet the training requirements specified
in §297.6 of this title (relating to Pharmacy Technician and
Pharmacy Technician Trainee Training).
(B) Initial training and continuing education.
(i) Pharmacy technicians and pharmacy technician trainees
may compound sterile preparations provided the pharmacy technicians
and/or pharmacy technician trainees are supervised by a pharmacist
as specified in paragraph (2) of this subsection.
(ii) All pharmacy technicians and pharmacy technician
trainees who compound sterile preparations for administration to patients
shall:
(I) have initial training obtained either through completion
of:
(-a-) a single course, a minimum of 40 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 course sponsored
by an ACPE accredited provider which provides 40 hours of instruction
and experience; or
(-b-) a training program which is accredited by the
American Society of Health-System Pharmacists.
(II) and
(-a-) 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
(-b-) possess knowledge about:
(-1-) aseptic processing;
(-2-) quality control and quality assurance as related
to environmental, component, and finished preparation release checks
and tests;
(-3-) chemical, pharmaceutical, and clinical properties
of drugs;
(-4-) container, equipment, and closure system selection;
and
(-5-) sterilization techniques.
(iii) Individuals enrolled in training programs accredited
by the American Society of Health-System Pharmacists may compound
sterile preparations in a licensed pharmacy provided the:
(I) compounding occurs only during times the individual
is assigned to a pharmacy as a part of the experiential component
of the American Society of Health-System Pharmacists training program;
(II) individual is under the direct supervision of
and responsible to a pharmacist who has completed training as specified
in paragraph (2) of this subsection;
(III) supervising pharmacist conducts periodic in-process
checks as defined in the pharmacy's policy and procedures; and
(IV) supervising pharmacist conducts a final check.
(iv) 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, is qualified
and has completed training as specified in paragraph (2) of this subsection
or this paragraph.
(v) In order to renew a registration as a pharmacy
technician, during the previous registration period, a pharmacy technician
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 pharmacy technician 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 pharmacy technician is engaged in compounding
high risk sterile preparations.
(4) Evaluation and testing requirements.
(A) All pharmacy personnel preparing sterile preparations
shall be trained conscientiously and skillfully by expert personnel
through multimedia instructional sources and professional publications
in the theoretical principles and practical skills of aseptic manipulations,
garbing procedures, aseptic work practices, achieving and maintaining
ISO Class 5 environmental conditions, and cleaning and disinfection
procedures before beginning to prepare compounded sterile preparations.
(B) All pharmacy personnel preparing sterile preparations
shall perform didactic review and pass written and media-fill testing
of aseptic manipulative skills initially followed by:
(i) every 12 months for low- and medium-risk level
compounding; and
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