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HHS/FDA

RIN: 0910-AA94

Publication ID: Spring 1999

Title: Labeling for Human Prescription Drugs; Revised Format
Abstract: The proposed regulation would amend the regulations governing the format and content of professional labeling for human prescription drug and biologic products, 21 CFR 201.56 and 201.57. The proposal would require that professional labeling include a section containing highlights of prescribing information, a section containing an index to prescribing information, reorder currently required information and make minor changes to its content, and establish minimum graphical requirements for professional labeling. The proposal would also eliminate certain unnecessary statements that are currently required to appear on prescription drug labels and move certain information to patient labeling.
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: Undetermined	Unfunded Mandates: Undetermined
CFR Citation: 21 CFR 201
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 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

Timetable:

Action	Date	FR Cite
NPRM	07/00/1999
NPRM Comment Period End	10/00/1999

Additional Information: Legal Authority continued: 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses
Included in the Regulatory Plan: Yes
Agency Contact: Nancy M. Ostrove Division of Drug Marketing, Advertising, and Communications Department of Health and Human Services Food and Drug Administration (HFD-42), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-2828 Lee D. Korb Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Veterinary Medicine, 7519 Standish Place, Room 164, MPN-4, HFV-200, Rockville, MD 20855 Phone:240 276-9258 Fax:240 276-7692 Email: lee.korb@fda.hhs.gov