2003N-0342 - Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
FDA Comment Number : EC2
Submitter : Mr. John Coster Date & Time: 07/27/2004 12:07:31
Organization : National Association of Chain Drug Stores
Category :
Issue Areas/Comments
Please accept the following attachment for comments on the agency's implementation of Section 17 of the Best Pharmaceuticals for Children Act of 2001 (P.L. 107-109 that requires pharmacies to include as part of the labeling of each consumer prescription package a toll-free number maintained by the Secretary of HHS to report to the FDA adverse reactions from medications.