Lawriter - OAC - 4729:5-10-04 Eligible drugs.

4729:5-10-04 Eligible drugs.

All dangerous drugs may be donated to a pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program if the drugs meet all the following requirements:

(A) Except as provided in paragraph (B) of this rule, the drugs are in their original sealed and tamper-evident unit dose packaging. The packaging must be unopened except that the drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed. If the drugs were packaged by a pharmacy, the name of the pharmacy and any other pharmacy identifiers must be removed from the packaging prior to dispensing or personally furnishing to a recipient patient. This may be accomplished by removing the drug from the pharmacy packaging or by removing the name from the outside packaging of a multiple dose, unit dose packaging system.

(1) The drugs have been in the possession of a licensed healthcare professional, terminal distributor of dangerous drugs, or drug distributor and not in the possession of the ultimate user.

(2) The drugs have been stored according to federal and state requirements. The drugs must have an expiration date of six months or greater.

(3) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection, that the drugs appear to be unadulterated, safe, and suitable for dispensing.

(4) The packaging must list the lot number and expiration date of the drug.

(5) The drugs must not have any physical signs of tampering or adulteration.

(6) The drug packaging must not have any physical signs of tampering.

(7) All confidential patient information must have been removed from the drug packaging.

(8) Except for controlled substances in a long-acting or extended-release form used for the treatment of opioid dependence or addiction, the drugs must not be controlled substances.

(9) The drugs must not be samples.

(B) Orally administered cancer drugs described in division (C) of section 3715.87 of the Revised Code that are not in original sealed and tamper-evident unit dose packaging may be donated to a drug repository program.

(1) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection, that the drugs appear to be unadulterated, safe, and suitable for dispensing.

(2) The drugs have been stored according to federal and state requirements.

(3) The drugs must have an expiration date of six months or greater.

(4) The packaging must list the expiration date of the drug.

(5) The drugs must not have any physical signs of tampering or adulteration.

(6) The drugs must not be controlled substances or drug samples.

(C) In the case of recalls, any donated drugs affected by the recall shall not be dispensed or personally furnished unless the lot number can be determined.

Replaces: 4729-35-04


Effective: 10/15/2019
Five Year Review (FYR) Dates: 10/15/2024
Promulgated Under: 119.03
Statutory Authority: 3715.873, 4729.26
Rule Amplifies: 3715.87 , 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 01/01/2006