Vidyya Medical News Service
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Volume 6 Issue 140 Published - 14:00 UTC 08:00 EST 19-May-2004 Next Update - 14:00 UTC 08:00 EST 20-May-2004
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FDA to require toll-free number on drug labels

New and refill prescriptions dispensed by retail and outpatient pharmacies must bear a toll-free MedWatch number for consumers to report adverse events, under an FDA proposal published in the Federal Register.

Covered are prescription drugs and OTC products approved by the FDA.

The agency said there are five ways pharmacies can provide this information: by use of a sticker, a preprinted vial cap, a separate sheet of paper, consumer medication information with or without FDA-approved medication guides.

FDA proposes to give pharmacies one year to comply with this rule.

It estimates that, depending on which method pharmacies use, the cost could be negligible or reach millions of dollars annually.

The public has until July 21, 2004 to comment.



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