Over-the-Counter Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates
other · Food and Drug Administration · Rule · Published 2000-06-20 · Effective 2000-07-20 · 65 FR 38191
Document
Document number
00-15427
Federal Register citation
65 FR 38191
CFR reference
21 CFR 201
Type
Rule
Action
Final rule; partial extension of compliance dates.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-06-20
Effective date
2000-07-20
HHS docket
Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201
Abstract
The Food and Drug Administration (FDA) is providing a partial extension of the compliance dates for its final rule that appeared in the Federal Register of March 17, 1999. The final rule established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. That final rule requires all OTC drug products to have the new, easy-to-read format and the revised labeling requirements within prescribed implementation periods. This partial extension provides 1 additional year for implementation for specific types of OTC drug products to be in compliance with the final rule.