Section 338.3621. Forms; eligible facility donation form, resident donation form, eligible participant form, transfer form, destruction form; requirements.

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 drug’s 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 drug’s 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 department’s website at  www.michigan.gov/healthlicense.

History: 2014 AACS.