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Expiration dating of prepackaged medications

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The bin has been "run dry," with a record made of the "run dry" date, since the addition of the recalled lot number in which all drugs were completely removed prior to filling with a subsequent lot number. An automated counting device shall be cleaned and maintained in accordance with recommended manufacturer guidelines and specifications. A pharmacy may return a dispensed drug to stock for redispensing that has never left the pharmacy premises or the control of the pharmacy delivery agent pursuant to § 54.1-3411.1 A 3 of the Code of Virginia under the following conditions: 1.

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 container–closure system for resale or for distribution to hospitals or other pharmacies.

A repackager is expected to meet the requirements of packaging practice under 21 CFR 210 through 226.

Because the packaging practice relates to packaging, processing, or holding a drug product intended for administration to humans or animals, the repackager is expected to comply with regulations such as those relating to the sections pertaining to quality control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, master production record, batch records and reprints, distribution records, storage control records, and complaint files.

is one who purchases and removes a drug product from the manufacturer's market container or bulk dosage container and places the product into a different container for distribution for human or animal use.

A repackager may or may not take ownership from the manufacturer.

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.

Most expiration dates are used as guidelines based on normal and expected handling and exposure to temperature.

Use prior to the expiration date does not guarantee the safety of a food or drug, and a product is not necessarily dangerous or ineffective after the expiration date. High-acid canned foods (tomatoes, fruits) will keep their best quality for 12 to 18 months; low-acid canned foods (meats, vegetables) for 2 to 5 years. A product that has passed its shelf life might still be safe, but quality is no longer guaranteed.

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.