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Expired Drugs: Still Safe And Effective?

-- Most people wouldn't dare take a prescription or over-the-counter drug after its expiration date. But a new study shows that most drugs are safe and effective far past the expiration date.

On Monday's edition of The Early Show, Dr. Philip Alper, professor of medicine at the University of California, and Dr. Judith Jones, former head of Post Marketing Surveillance for the Food and Drug Administration, and now a consultant, explained the results and implications of the study.

Fifteen years ago, the U.S. military decided to find out if drugs really stop working after their expiration date. The military had $1 billion worth of stockpiled drugs and were faced with destroying and replacing the supply every two or three years.

So they began a testing program to see if it could extend the life of its inventory. The testing was conducted by the FDA and covered more than 100 prescription and over-the-counter drugs.

The results, first reported last week, show that about 90 percent of them were safe and effective far past their original expiration date.

Critics of drug expiration dates say that manufacturers put expiration dates on for marketing rather than scientific reasons. They say it is not profitable for them to have products on a shelf for 10 years because the manufacturers want turnover.

Drug-industry officials don't dispute the results of the FDA's testing. They acknowledge that expiration dates have commercial dimensions, but they say that relatively short shelf lives make sense from a public-safety standpoint as well.

Some manufacturers first began putting expiration dates on drugs in the 1960s, although they didn't have to. When the FDA began requiring such dating in 1979, the main effect was to set uniform testing and reporting guidelines.

As now required by the FDA, so-called stability testing analyzes the capacity of a drug to maintain its identity, strength, quality and purity for whatever period the manufacturer chooses. If the company picks a two-year expiration date, it needn't test beyond that. And when pharmacists dispense a drug in any container other than what it came to them in, they routinely cut the expiration date to just one year after dispensing.

So is this just a means for drug companies to sell more drugs? Should we ignore expiration dates? Or are there good reasons for conservative expiration dates? These are just a few of the questions Dr. Philip Alper and Judith Jones will answer on The Early Show.

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