Section 338.3607. Ineligible drugs; controlled substances prohibited.

(1) The following shall not be accepted for dispensing under the program:

(a)    Controlled substances, as defined in article 7 of the code or by federal law.

(b)    Expired prescription drugs.

(c)     Drugs that may be dispensed only to a patient registered with the drug’s manufacturer under federal food and drug administration requirements.

(d)    Drugs that have been held outside of a health professional’s control where sanitation and security cannot be assured.

(e)    Compounded drugs.

(f)    Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or the usp-nf shall not be donated or accepted as part of the program. Excluded from this restriction are drugs donated directly from a drug manufacturer.

(2)      Controlled substances submitted for donation shall be documented and returned immediately to the eligible facility that donated the drugs. Both of the following apply:

(a)        If controlled substances enter the participating pharmacy or charitable clinic and it is not possible or practicable to return the controlled substances to the donating facility, abandoned controlled substances shall be documented and destroyed pursuant to the protocols currently used by the pharmacy.

(b)      A destruction record shall be created and maintained for a period of 5 years after destruction for any controlled substances destroyed.

History: 2014 AACS.