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2011-05-11
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates
Rules and Regulations
D09002ee1bdeffeac
D09002ee1bdf0055a
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is providing a partial delay of the compliance dates for certain products subject to its final rule that established standardized format and content requirements for the labeling of over-the-counter (OTC) drug products (Drug Facts Rule). That final rule requires all OTC drug products to comply with new format and labeling requirements within prescribed implementation periods. The agency intends in a future issue of the Federal Register to propose an amendment to the Drug Facts Rule to modify the labeling requirements for ``convenience-size'' OTC drug products. This final rule postpones the compliance dates under the Drug Facts Rule for certain convenience-size OTC drug products pending the outcome of the future rulemaking.
67 FR 16304
https://www.govinfo.gov/app/details/FR-2002-04-05/02-8193
02-8193
fr05ap02-4
RIN 0910-AA79
4160-01-S
Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201
https://www.govinfo.gov/app/details/FR-2002-04-05/02-8193
https://www.govinfo.gov/content/pkg/FR-2002-04-05/html/02-8193.htm
https://www.govinfo.gov/content/pkg/FR-2002-04-05/pdf/02-8193.pdf
5 p.
16304
16308
67 FR 16304
Code of Federal Regulations
Title 21 Part 201
21 CFR Part 201
Code of Federal Regulations
Title 21 Part 330
21 CFR Part 330
Code of Federal Regulations
Title 21 Part 331
21 CFR Part 331
Code of Federal Regulations
Title 21 Part 341
21 CFR Part 341
Code of Federal Regulations
Title 21 Part 346
21 CFR Part 346
Code of Federal Regulations
Title 21 Part 355
21 CFR Part 355
Code of Federal Regulations
Title 21 Part 358
21 CFR Part 358
Code of Federal Regulations
Title 21 Part 369
21 CFR Part 369
Code of Federal Regulations
Title 21 Part 701
21 CFR Part 701
Regulation Identification Number 0910-AA79
RIN 0910-AA79
Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates; Federal Register Vol. 67, Issue
RULE
02-8193
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2002-05-06
Docket Nos. 98N-0337, 96N-0420, 95N-0259, and 90P-0201
4160-01-S
02-8193
Final rule; partial delay of compliance dates.
The Food and Drug Administration (FDA) is providing a partial delay of the compliance dates for certain products subject to its final rule that established standardized format and content requirements for the labeling of over-the-counter (OTC) drug products (Drug Facts Rule). That final rule requires all OTC drug products to comply with new format and labeling requirements within prescribed implementation periods. The agency intends in a future issue of the Federal Register to propose an amendment to the Drug Facts Rule to modify the labeling requirements for ``convenience-size'' OTC drug products. This final rule postpones the compliance dates under the Drug Facts Rule for certain convenience-size OTC drug products pending the outcome of the future rulemaking.
Effective Date: This rule is effective May 6, 2002.
Gerald M. Rachanow or Cazemiro R. Martin, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 2307.
Human drugs:
Labeling of drug products (OTC)
Standardized format; compliance dates partially delayed,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 67, no. 66
Office of the Federal Register, National Archives and Records Administration
2002-04-05
continuing
daily
deposited
born digital
354 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2002-04-05
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0042-1219
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https://www.govinfo.gov/app/details/FR-2002-04-05
https://www.govinfo.gov/content/pkg/FR-2002-04-05/pdf/FR-2002-04-05.pdf
https://www.govinfo.gov/content/pkg/FR-2002-04-05/xml/FR-2002-04-05.xml
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2011-05-11
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