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Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.

Gerona and Cantrell, a pharmacist and toxicologist, knew that the term “expiration date” was a misnomer.

In the late 1970s, the FDA first began requiring expiration dates on both prescription and over-the-counter medications.“To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing,” reads the agency’s regulation.Will it cause harm or just not work after its expiration date?Neither fully explains what the expiration date means.Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects. “Who gets the chance of analyzing drugs that have been in storage for more than 30 years?” The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn’t.A beyond-use date of 6 months when stored frozen at -20°C and 1 month when stored refrigerated at 4°C is appropriate for batches of the injection that have passed sterility testing.

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