Expiration dating of prepackaged medications
In some regions, an advisory best before, mandatory use by or freshness date is required on packaged perishable foods.Shelf life is the recommended maximum time for which products or fresh (harvested) produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected (or specified) conditions of distribution, storage and display.Failure on the basis of potency, p H, water content, dissolution, physical appearance, or presence of impurities occurred in 479 lots (~18%), but none failed within 1 year.Potassium iodide, which has been extensively stockpiled for use in a radiation emergency, has shown no significant degradation over many years.4HEAT, HUMIDITY, AND LONG-TERM STORAGE — Storage in high heat and/or humidity can accelerate the degradation of some drug formulations, but in one study, captopril tablets, theophylline tablets (, and others), stored at 40°C and 75% relative humidity, remained stable for 1.5-9 years beyond their expiration dates.5 In another study, theophylline retained 90% of its potency 30 years past its expiration date.6 A study of eight products that had been stored in their unopened original containers for 28-40 years past expiration found that 12 of 14 active ingredients had retained ≥90% of their original potency; aspirin retained 50 years past expiration) were all found to contain significant amounts of the drug.8 Drugs in solution that have become cloudy or discolored or show signs of precipitation, particularly injectables, should not be used.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.
A pharmacist who repackages under the state law needs to apply (1) the principal information provided in the USP general information chapter This chapter provides information to any person who removes drugs from their original manufacturer's container and repacks them into a different containerclosure system for resale or for distribution to hospitals or other pharmacies.
According to the USDA, "canned foods are safe indefinitely as long as they are not exposed to freezing temperatures, or temperatures above 90 °F (32.2° C). In most food stores, waste is minimized by using stock rotation, which involves moving products with the earliest sell by date from the warehouse to the sales area, and then to the front of the shelf, so that most shoppers will pick them up first and thus they are likely to be sold before the end of their shelf life.
This is important, as consumers enjoy fresher goods, and furthermore some stores can be fined for selling out of date products; most if not all would have to mark such products down as wasted, resulting in a financial loss.
Renal tubular damage has been reported with use of degraded tetracycline in a formulation that is no longer available.2THE EXPIRATION DATE — The manufacturer's expiration date is based on the stability of the drug in the original sealed container.
The date does not necessarily mean that the drug was found to be unstable after a longer period; it only means that real-time data or extrapolations from accelerated degradation studies indicate that the drug in the closed container will still be stable at that date.