New Jersey News: Toll-Free Number for Reporting Adverse Events to be Distributed with All Prescriptions

January 1, 2009 3:07 pm Topics: Prescription label

Reprinted from the January 2009 New Jersey Board of Pharmacy Newsletter.

A final rule has been issued by Food and Drug Administration (FDA) (21CFR Parts 201, 208, and 209), which will require all authorized dispensers and pharmacies to provide consumers with a side-effects statement. The statement consists of two parts:
1. a toll-free number for reporting adverse events; and
2. a statement that the number is to be used solely for reporting purposes and not to solicit medical advise.
The effective date for the rule was November 28, 2008, with a compliance date of July 1, 2009. The side-effects statement will be required for all new and refill prescriptions, and may be provided by one or more of the following methods:
1. a sticker attached to the prescription label;
2. a preprinted prescription vial cap;
3. a separate sheet of paper;
4. an addition to the consumer medication information (CMI), and/or;
5. an addition to the FDA-approved Medication Guide.