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One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data. [9]The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a ...
The FDA said it uses data from initial study results to create an expiration date, which is usually about four to six months from the day the test was manufactured.
The FDA extends expiration dates when a manufacturer provides data showing that its test’s shelf life is longer than what was known when the agency first approved the product.
The FDA explains the expiration date is set at the end of the shelf-life and is the date through which the test is expected to perform as accurately as when manufactured.
The study showed that about 90% of them were safe and effective as long as 15 years past their expiration dates. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions - notably nitroglycerin, insulin and some liquid antibiotics - most expired drugs are probably effective. [10]
Manufacturers print expiration dates on drug bottle labels. [4] The labeled expiration date is a manufacturer's promise for a time until which the drug will have full efficacy and be safe as manufactured. [4] The labeled expiration date is not an indication of when a drug has become ineffective or unsafe to use. [4]
After health officials expanded expiration dates for COVID-19 tests, you may wonder about using expired tests. Here's what experts say about accuracy.
PEPFAR President's Emergency Plan for AIDS Relief (PEPFAR) Database 20. Product-Specific Guidances for Generic Drug Development Database 21. Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) 22. Wholesale Distributor and Third-Party Logistics Providers Reporting