Nevada News: FDA Statement

July 1, 2009 12:10 PM Topics: Prescriptions

Reprinted from the July 2009 Nevada State Board of Pharmacy Newsletter.

Effective July 1, 2009, the Food and Drug Administration (FDA) Amendments Act of 2007 mandates that pharmacies must provide the patient, on all new and refill prescriptions, with the FDA phone number for reporting adverse events. The statement must include the following: “Call your practitioner for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.”

There are several acceptable methods of giving this information to the patient:
 

In consumer medication information (Patient-Package Inserts [PPI])On a separate piece of paper
On a sticker attached to the medication container
On a preprinted prescription vial cap
In an FDA-approved medication guide
 

The original date of implementation was set for January 1, 2009; however, FDA delayed the rule in October 2008 to the July 2009 date. For further information on the rule, please access www.mtpharmacist.org/documents/FR0
4-9069_FDA_phone#.pdf.