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HHS/FDA

RIN: 0910-AC35

Publication ID: Spring 2003

Title: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs
Abstract: To require the labeling of human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free number for reports of adverse events, and a statement that the number is to be used for reporting purposes only and not to receive medical advice.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 201 21 CFR 208 21 CFR 209
Legal Authority: 21 USC 355a

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		01/04/2003

Statement of Need: Consumers may not be aware of FDA's adverse event reporting program under Medwatch. This requirement will promote FDA's mission to protect the public health by informing consumers of FDA's Medwatch system.

Summary of the Legal Basis: Section 17 of the Best Pharmaceuticals for Children Act (BPCA) requires a final rule to issue within one year of the date of its enactment on January 4, 2002.

Alternatives: This final rule is required by section 17 of the BPCA. FDA has considered alternatives within the scope of the statutory requirements, in particular, ways to reach the broadest consumer audience and to minimize costs to the pharmacy profession.

Anticipated Costs and Benefits: Anticipated costs are to drug manufacturers and authorized dispensers of drug products, including pharmacies. The BPCA contains a provision requiring the Secretary to seek to minimize the cost to the pharmacy profession. Anticipated benefits are to obtain information about adverse events from consumers, which may inform FDA of trends in reported adverse events and result in a review of the safety and/or effectiveness of particular drug products on the market.

Risks: None.

Timetable:

Action	Date	FR Cite
NPRM	09/00/2003

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
Agency Contact: Carol Drew Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440