| 14 days.
(K) The pharmacist-in-charge shall ensure continuing
competency of pharmacy personnel through in-service education, training,
and media-fill tests to supplement initial training. Personnel competency
shall be evaluated:
(i) during orientation and training prior to the regular
performance of those tasks;
(ii) whenever the quality assurance program yields
an unacceptable result;
(iii) whenever unacceptable techniques are observed;
and
(iv) at least on an annual basis for low- and medium-risk
level compounding, and every six months for high-risk level compounding.
(L) The pharmacist-in-charge shall ensure that proper
hand hygiene and garbing practices of compounding personnel are evaluated
prior to compounding, supervising, or verifying sterile preparations
intended for patient use and whenever an aseptic media fill is performed.
(i) Sampling of compounding personnel glove fingertips
shall be performed for all risk level compounding. If pharmacies are
under common ownership and control, the gloved fingertip sampling
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 gloved
fingertip sampling of all compounding personnel.
(ii) All compounding personnel shall demonstrate competency
in proper hand hygiene and garbing procedures and in aseptic work
practices (e.g., disinfection of component surfaces, routine disinfection
of gloved hands).
(iii) Sterile contact agar plates shall be used to
sample the gloved fingertips of compounding personnel after garbing
in order to assess garbing competency and after completing the media-fill
preparation (without applying sterile 70% IPA).
(iv) The visual observation shall be documented and
maintained to provide a permanent record and long-term assessment
of personnel competency.
(v) All compounding personnel shall successfully complete
an initial competency evaluation and gloved fingertip/thumb sampling
procedure no less than three times before initially being allowed
to compound sterile preparations for patient use. Immediately after
the compounding personnel completes the hand hygiene and garbing procedure
(i.e., after donning of sterile gloves and before any disinfecting
with sterile 70% IPA), the evaluator will collect a gloved fingertip
and thumb sample from both hands of the compounding personnel onto
contact plates or swabs by having the individual lightly touching
each fingertip onto the testing medium. The contact plates or swabs
will be incubated for the appropriate incubation period and at the
appropriate temperature. Results of the initial gloved fingertip evaluations
shall indicate zero colony-forming units (0 CFU) growth on the contact
plates or swabs, or the test shall be considered a failure. In the
event of a failed gloved fingertip test, the evaluation shall be repeated
until the individual can successfully don sterile gloves and pass
the gloved fingertip evaluation, defined as zero CFUs growth. No preparation
intended for patient use shall be compounded by an individual until
the results of the initial gloved fingertip evaluation indicate that
the individual can competently perform aseptic procedures except that
a pharmacist may temporarily physically supervise pharmacy technicians
compounding sterile preparations before the results of the evaluation
have been received for no more than three days from the date of the
test.
(vi) Re-evaluation of all compounding personnel shall
occur at least annually for compounding personnel who compound low
and medium risk level preparations and every six months for compounding
personnel who compound high risk level preparations. Results of gloved
fingertip tests conducted immediately after compounding personnel
complete a compounding procedure shall indicate no more than 3 CFUs
growth, or the test shall be considered a failure, in which case,
the evaluation shall be repeated until an acceptable test can be achieved
(i.e., the results indicated no more than 3 CFUs growth).
(M) The pharmacist-in-charge shall ensure surface sampling
shall be conducted in all ISO classified areas on a periodic basis.
Sampling shall be accomplished using contact plates or swabs at the
conclusion of compounding. The sample area shall be gently touched
with the agar surface by rolling the plate across the surface to be
sampled.
(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 Cont'd... |
