Over-The-Counter Human Drugs; Labeling Requirements
other · Food and Drug Administration · Rule · Published 1999-03-17 · Effective 1999-04-16 · 64 FR 13254
Document
Document number
99-6296
Federal Register citation
64 FR 13254
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-03-17
Effective date
1999-04-16
HHS docket
Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201
Abstract
The Food and Drug Administration (FDA) is issuing a final rule establishing a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. This final rule is intended to assist consumers in reading and understanding OTC drug product labeling so that consumers may use these products safely and effectively. This final rule will require all OTC drug products to carry the new, easy-to-read format and the revised content requirements within prescribed implementation periods.