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Pharmacy Practice

FDA issues new rules on compounding

Published in Medical Letter on the CDC and FDA, July 7th, 2002

U.S. pharmacists cannot brew up large batches of unapproved drugs to sell, the government said June 4, 2002, in new guidelines for specially mixed medications.

The new regulations are meant to replace rules struck down by the Supreme Court.

Pharmacists have long "compounded" drugs, altering or specially brewing a prescription medicine to fit a patient's special needs instead of simply dispensing a drug made by a pharmaceutical company. Often, compounding merely means adding child-friendly flavorings to bad-tasting drugs, removing an allergy-causing ingredient or making a drug easier to swallow.

In recent years, though, some...

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