Section 13.13. Returned, damaged and outdated prescription drug requirements.

 

(1)  Prescription drugs in a facility that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or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.

(2)  Any prescription drugs in a facility 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.

(3)  If the conditions under which a prescription drug has been returned to a facility cast doubt on the product's safety, identity, strength, quality, or purity, then the product shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the product meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a product has been returned cast doubt on its safety, identity, strength, quality, or purity, the distributor shall consider, among other things, the conditions under which the product has been held, stored, or shipped before or during its return and the condition of the product and its container, carton, or labeling, as a result of storage or shipping.

(4)  The recordkeeping requirements in s. Phar 13.14 shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

History: Cr. Register, July, 1992, No. 439 , eff. 8-1-92; EmR0815 : emerg. am. eff. 6-1-08; CR 08-051 : am. Register November 2008 No. 635 , eff. 12-1-08.