Alabama News: FDA Amendments Act of 2007

November 1, 2008 12:40 pm Topics: Prescriptions

Published in the November 2008 Alabama State Board of Pharmacy Newsletter

For further information, refer to the Federal Register Vol. 73, No. 2 published January 3, 2008

Manufacturers of drug products, authorized dispensers, and pharmacies, will be required to provide a side effect statement with each prescription drug product, which must read:

“Call your doctor for medical advice about side effects. You may report side effects to Food and Drug Administration (FDA) at 1-800-FDA-1088.”

a. The side effects statement must be distributed with new and refill prescriptions.
b. An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement:

1. distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product;
2. distribute the side effects statement on a preprinted pharmacy vial cap;
3. distribute the side effects statement on a separate sheet of paper;
4. distribute the side effects statement in a consumer medication information; or
5. distribute the appropriate FDA-approved Medication Guide that contains the side effects statement.

Effective Date: January 1, 2008
Compliance Date: January 1, 2009