Section 1330.730  Drug Prepackaging

a)         The term prepackaged, as used in this Section, is defined as any drug being removed from the original manufacturer container and placed in a dispensing container for other than immediate dispensing to a patient.

b)         Any prepackaged drugs must have a label affixed that contains, at a minimum, the name and strength of the drug, the name of manufacturer or distributor, beyond use date, and lot number.  Maximum beyond use date allowed for prepackaged drugs shall be the manufacturer's beyond use date or 12 months, whichever is less.  Pharmacies that store drugs with an automated counting device may, in place of the required labels, maintain separate records of lot numbers and beyond use dates as long as those records are fully traceable and readily retrievable during an inspection. 

c)         Automatic counting cassettes must have a label affixed to the cassette containing the information required in subsection (b).