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HHS/FDA

RIN: 0910-AF11

Publication ID: Spring 2011

Title: Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 201.56 and 201.57 21 CFR 201.80
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360b 21 USC 360gg to 360ss 21 USC 371 21 USC 374 21 USC 379e 42 USC 216 42 USC 241 42 USC 262 42 USC 264

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	05/29/2008	73 FR 30831
NPRM Comment Period End	08/27/2008
Final Action	To Be Determined

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: State
Small Entities Affected: Businesses	Federalism: Yes
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Rachel S. Bressler Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4288 Fax:301 847-8440 Email: rachel.bressler@fda.hhs.gov