N.J. Admin. Code § 8:21-3A.12

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:21-3A.12 - Returned, damaged and outdated prescription drugs

(a) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

(b) Prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

(c) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality or purity, then the drug shall be destroyed or returned to the supplier, unless examination, testing or other investigation proves the drug meets appropriate standards of safety, identity, strength, quality and purity. The wholesale distributor of prescription drugs shall consider, among other things, the conditions under which the drugs were held, stored, or shipped before or during their return and the condition of the drug and its container, carton, or labeling as a result of storage and shipping when considering that there is any doubt of the drug's safety, identity, strength, quality or purity.

N.J. Admin. Code § 8:21-3A.12