| (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
(ii) every six months for high-risk level compounding.
(C) Pharmacy personnel who fail written tests or whose
media-fill tests result in gross microbial colonization shall:
(i) be immediately re-instructed and re-evaluated by
expert compounding personnel to ensure correction of all aseptic practice
deficiencies; and
(ii) not be allowed to compound sterile preparations
for patient use until passing results are achieved.
(D) The didactic and experiential training shall include
instruction, experience, and demonstrated proficiency in the following
areas:
(i) aseptic technique;
(ii) critical area contamination factors;
(iii) environmental monitoring;
(iv) structure and engineering controls related to
facilities;
(v) equipment and supplies;
(vi) sterile preparation calculations and terminology;
(vii) sterile preparation compounding documentation;
(viii) quality assurance procedures;
(ix) aseptic preparation procedures including proper
gowning and gloving technique;
(x) handling of hazardous drugs, if applicable;
(xi) cleaning procedures; and
(xii) general conduct in the clean room.
(E) The aseptic technique of each person compounding
or responsible for the direct supervision of personnel compounding
sterile preparations shall be observed and evaluated by expert personnel
as satisfactory through written and practical tests, and challenge
testing, and such evaluation documented. Compounding personnel shall
not evaluate their own aseptic technique or results of their own media-fill
challenge testing.
(F) Media-fill tests must be conducted at each pharmacy
where an individual compounds low or medium risk sterile preparations.
If pharmacies are under common ownership and control, the media-fill
testing may be conducted at only one of the pharmacies provided each
of the pharmacies are operated under equivalent policies and procedures
and the testing is conducted under the most challenging or stressful
conditions. In addition, each pharmacy must maintain documentation
of the media-fill test. No preparation intended for patient use shall
be compounded by an individual until the on-site media-fill tests
indicate that the individual can competently perform aseptic procedures,
except that a pharmacist may temporarily compound sterile preparations
and supervise pharmacy technicians compounding sterile preparations
without media-fill tests provided the pharmacist completes the on-site
media-fill tests within seven days of commencing work at the pharmacy.
(G) Media-fill tests must be conducted at each pharmacy
where an individual compounds high risk sterile preparations. No preparation
intended for patient use shall be compounded by an individual until
the on-site media-fill tests indicate that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily
compound sterile preparations and supervise pharmacy technicians compounding
sterile preparations without media-fill tests provided the pharmacist
completes the on-site media-fill tests within seven days of commencing
work at the pharmacy.
(H) Media-fill testing procedures for assessing the
preparation of specific types of sterile preparations shall be representative
of the most challenging or stressful conditions encountered by the
pharmacy personnel being evaluated and, if applicable, for sterilizing
high-risk level compounded sterile preparations.
(I) Media-fill challenge tests simulating high-risk
level compounding shall be used to verify the capability of the compounding
environment and process to produce a sterile preparation.
(J) Commercially available sterile fluid culture media
for low and medium risk level compounding or non-sterile fluid culture
media for high risk level compounding shall be able to promote exponential
colonization of bacteria that are most likely to be transmitted to
compounding sterile preparations from the compounding personnel and
environment. Media-filled vials are generally incubated at 20 to 25
degrees Celsius or at 30 to 35 degrees Celsius for a minimum of 14
days. If two temperatures are used for incubation of media-filled
samples, then these filled containers should be incubated for at least
7 days at each temperature. Failure is indicated by visible turbidity
in the medium on or before Cont'd... |
