Michigan Administrative Code
Department - Licensing and Regulatory Affairs
Bureau of Professional Licensing
Board of Pharmacy
Program for Utilization of Unused Prescription Drugs
Section R. 338.3621 - Forms; eligible facility donation form, resident donation form, eligible participant form, transfer form, destruction form; requirements
Universal Citation: MI Admin Code R. 338.3621
Current through Vol. 24-16, September 15, 2024
Rule 21.
(1) An eligible facility donation form shall include all of the following information:
(a) An eligible facility's or manufacturer's
name, address, and telephone number; the name, dated signature, and license
number of pharmacist or health care provider authorized to donate the drugs;
and, the license number of the facility or manufacturer.
(b) A statement of the facility's intent to
participate in the program and donate eligible prescription drugs to the
participating pharmacy or charitable clinic identified on the form.
(c) The receiving participating pharmacy's or
charitable clinic's name, address, and telephone number.
(d) The name, state of Michigan license
number, and dated signature of the responsible pharmacist authorized to receive
the donation.
(e) The date the
donation was received.
(2) A resident donation form shall include all of the following information:
(a) The
eligible facility's name, address, state of Michigan license or registration
number, and telephone number; and the name, dated signature, and license number
of pharmacist or health care provider authorized to donate the drugs.
(b) The resident's name and dated signature,
or the name and dated signature of the resident's representative or
guardian.
(c) Attestation to the
following statement, "As the legal owner of the listed prescription drug(s), I
agree to voluntarily donate the listed eligible unused drugs to the program for
utilization of unused prescription drugs."
(d) The drug brand name or generic name, the
name of manufacturer or national drug code number (ndc#), the quantity and
strength of the drug, and the drugs expiration date.
(e) The date of the donation.
(f) The name, address, telephone number and
state of Michigan license or registration number of the pharmacy or charitable
clinic receiving donated unused prescription drug.
(g) The date the donated drugs are received
by the pharmacy or charitable clinic.
(h) The name, state of Michigan license or
registration number, and dated signature of the authorized pharmacist or health
care provider receiving the donated prescription drug.
(3) The eligible participant form shall include all of the following information:
(a)
The participating pharmacy's or charitable clinic's name, address, telephone
number, state of Michigan license or registration number, and the name, state
of Michigan license or registration number, and dated signature of dispensing
pharmacist.
(b) The drug's brand
name or generic name, the name of manufacturer or national drug code number
(ndc#), the quantity and strength of the drug, the date the drug was dispensed,
and the drugs expiration date.
(c)
The eligible participant's name, date of birth, address, and dated
signature.
(d) Attestation of all
of the following:
(i) The eligible participant
is a resident of this state.
(ii)
The eligible participant is eligible to receive medicare or medicaid or is
uninsured and does not have prescription drug coverage.
(e) The eligible participant acknowledges
that the drugs have been donated.
(f) The eligible participant consents to a
waiver of the requirement for child resistant packaging, as required by the
poison prevention packaging act, being
15
U.S.C. §1471 -
1477.
(4) The transfer form shall include all of the following information:
(a)
The eligible facility or manufacturer's name, state of Michigan license or
registration number, address, telephone number, and the name, dated signature,
and state of Michigan license number of the responsible pharmacist.
(b) The date of donation.
(c) The drug's brand name or generic name,
the name of manufacturer or national drug code number (ndc#), the quantity and
strength of the drug, and the drug's expiration date.
(d) The pharmacist of the eligible facility
or manufacturer shall attest to the following statement, "I certify that the
prescription drugs listed on this form for donation are eligible for donation
and meet the requirements for prescription drugs under the program, including
any storage requirements."
(e) The
receiving participating pharmacy's or charitable clinic's name, address, and
telephone number, and name and state of Michigan license number of responsible
pharmacist authorized to receive the donation.
(f) The responsible pharmacist shall sign and
date the transfer form attesting to the following statement, "Upon receipt and
inspection of the above listed donated prescription drugs, it is in my
professional judgment that these drugs are not adulterated, are safe and
suitable for dispensing, and are eligible drugs."
(5) The destruction form shall include all of the following:
(a) The participating
pharmacy's or charitable clinic's name, state of Michigan license number,
address, telephone number, the name, dated signature, and license number of the
responsible pharmacist.
(b) The
drug's brand name or generic name, the name of the manufacturer or national
drug code number (ndc#), the quantity and strength of the drug, and the drug's
expiration date.
(c) The reason for
destruction of the drug.
(d) The
name, title, and dated signature of the witness.
(e) The date of destruction.
(f) If off-site disposal is used, the name of
the firm destroying or disposing the drug, the name and dated signature of the
person at the firm destroying or disposing the drug, and the date of
disposal.
(6) All forms 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.
(7) The department shall make available all forms required by the program. The forms shall be available at no cost from the Department of Licensing and Regulatory Affairs, Bureau of Health Care Services, 611 W. Ottawa St., Lansing, MI 48909 or on the departments website at www.michigan.gov/healthlicense.
Disclaimer: These regulations may not be the most recent version. Michigan may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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