Mich. Admin. Code R. 338.3619 - Record keeping; inventory; requirements
Rule 19.
(1) A
participating pharmacy or charitable clinic shall keep records in conformance
with these rules and all applicable federal and state laws, rules, and
regulations.
(2) A participating
pharmacy or charitable clinic shall maintain documented policies and procedures
that will address all the requirements of these rules.
(3) A participating pharmacy or charitable
clinic shall document all of the following for each drug accepted for the
program:
(a) Brand name or generic name of
the drug.
(b) Name of the
manufacturer or national drug code number (ndc#).
(c) Quantity and strength of the
drug.
(d) Lot number of medication,
if available.
(e) Expiration date
of medication.
(f) Date the drug
was donated and the date the drug was subsequently dispensed.
(g) Name of the eligible facility that
donated the drug and the eligible participant subsequently dispensed the
drug.
(h) The prescription from a
health care professional.
(4) All records required for participation in
the program shall be maintained separate from other records for 5 years and
shall be readily retrievable for inspection at the request of the department or
its agent.
Notes
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