All dangerous drugs, except controlled substances and drug samples, may be donated to a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program if the drugs meet all of the following requirements:
(A) 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 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.
(B) The drugs have been in the possession of a licensed healthcare professional and not in the possession of the ultimate user.
(C) The drugs have been stored according to Federal Food and Drug Administration storage requirements.
(D) The drugs must have an expiration date of six months or greater.
(E) The packaging must list the lot number and expiration date of the drug.
(F) The drugs must not have any physical signs of tampering or adulteration.
(G) The drug packaging must not have any physical signs of tampering.
(H) All confidential patient information must have been removed from the drug packaging.
119.032 review dates:
Promulgated Under: 119.03
Statutory Authority: 3715.873 , 4729.26
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004, 1/1/2006