In other words, it might refer to whether a commodity should no longer be on a pantry shelf (unfit for use), or just no longer on a supermarket shelf (unfit for sale, but not yet unfit for use).
It applies to cosmetics, foods and beverages, medical devices, medicines, explosives, pharmaceutical drugs, chemicals, tires, batteries and many other perishable items.
This chapter is intended to provide guidance to those engaged in repackaging of drug products in accordance with 21 CFR 10.90.
A bin filling record shall be maintained, manually or in a computerized record for a period of one year from date of filling from which information can be readily retrieved, for each bin including: a. The removal of drugs from the bin is not required if: a.
The technology of the automated counting device can ensure drugs in a particular lot have been cleared; or b.
These functions are beyond the regular practice of a pharmacist.
A repackager is required to register with the FDA and comply with current Good Manufacturing Practices (c GMPs) regulations in 21 CFR 210 and 211.
Healthcare providers are often asked if drugs can be used past their expiration date.
Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not even comment on the safety or effectiveness of their products beyond the date on the label. Pharmacies in which bulk reconstitution of injectable, bulk compounding or the repackaging or prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater.The records shall show the name of the drug(s) used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date. The drug name; strength, if any; the assigned lot or control number or the manufacturer's or distributor's name and lot or control number; and an appropriate expiration date determined by the pharmacist in accordance with USP guidelines shall appear on any subsequently repackaged or reconstituted units. Pharmacies using automated counting devices or dispensers in which drugs are removed from manufacturer's original packaging and placed in bulk bins shall comply with the following requirements: 1. Manufacturer's control or lot number(s) and expiration date for all lots placed into the bin at the time of filling; d. An expiration date determined according to USP guidelines for repackaging; f. The pharmacist's initials verifying the accuracy of the process. If more than one lot is added to a bin at the same time, the lot which expires first shall be used to determine the expiration date if shorter than a calculated date based on USP guidelines. Each bin shall be labeled in such a manner as to cross-reference the information on the filling record with the correct expiration date. If only one lot is added to a bin at one time, but a subsequent lot may be added before the first has cleared, the automated device shall be constructed to reasonably dispense the first lot before the second lot is dispensed and the expiration date on the bin's label shall reflect the expiration date assigned to the earlier lot. In the event of a drug recall involving one of multiple lots placed in a bin of an automated counting device in the last three months or if a recalled drug is known to remain in the bin, all drugs shall be removed from the bin and not used for patient care.Since our last publication on this subject,1 more data have become available.SAFETY — There are no published reports of human toxicity due to ingestion, injection, or topical application of a current drug formulation after its expiration date.In the absence of stability data to the contrary, the date on the label may not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. The restocked drug shall be used to fill the next prescription received for that product.