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2010-09-24
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Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels
Part III
Proposed Rules
D09002ee1bdf9b0d2
D09002ee1bdf9b1e6
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format and content of labeling for human prescription drug and biologic products. This proposal would revise current regulations to require that the labeling of new and recently approved products include a section containing highlights of prescribing information and a section containing an index to prescribing information, reorder currently required information and make minor changes to its content, and establish minimum graphical requirements. These revisions would make it easier for health care practitioners to access, read, and use information in prescription drug labeling and would enhance the safe and effective use of prescription drug products. This proposal would also amend prescription drug labeling requirements for older drugs to require that certain types of statements currently appearing in labeling be removed if they are not sufficiently supported. Finally, the proposal would eliminate certain unnecessary statements that are currently required to appear on prescription drug product labels and move other, less important information to labeling. These changes would simplify drug product labels and reduce the possibility of medication errors.
65 FR 81082
https://www.govinfo.gov/app/details/FR-2000-12-22/00-32375
00-32375
fr22de00-36
RIN 0910-AA94
4160-01-P
Docket No. 00N-1269
https://www.govinfo.gov/app/details/FR-2000-12-22/00-32375
https://www.govinfo.gov/content/pkg/FR-2000-12-22/html/00-32375.htm
https://www.govinfo.gov/content/pkg/FR-2000-12-22/pdf/00-32375.pdf
Drugs
Labeling
Reporting and Recordkeeping Requirements
50 p.
81082
81131
65 FR 81082
Code of Federal Regulations
Title 21 Part 201
21 CFR Part 201
Regulation Identification Number 0910-AA94
RIN 0910-AA94
Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels; Federal Register Vol. 65, Issue
PRORULE
00-32375
III
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2001-03-22
Docket No. 00N-1269
4160-01-P
00-32375
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its regulations governing the format and content of labeling for human prescription drug and biologic products. This proposal would revise current regulations to require that the labeling of new and recently approved products include a section containing highlights of prescribing information and a section containing an index to prescribing information, reorder currently required information and make minor changes to its content, and establish minimum graphical requirements. These revisions would make it easier for health care practitioners to access, read, and use information in prescription drug labeling and would enhance the safe and effective use of prescription drug products. This proposal would also amend prescription drug labeling requirements for older drugs to require that certain types of statements currently appearing in labeling be removed if they are not sufficiently supported. Finally, the proposal would eliminate certain unnecessary statements that are currently required to appear on prescription drug product labels and move other, less important information to labeling. These changes would simplify drug product labels and reduce the possibility of medication errors.
Submit written comments by March 22, 2001. Submit written comments on the information collection requirements by January 22, 2001.
For information on drug product labeling:
Drugs
Labeling
Reporting and Recordkeeping Requirements
Human drugs and biological products:
Prescription drug products; labeling requirements,
Korbl@CDER.FDA.GOV
Ostrove@CDER.FDA.GOV
Stifano@CBER.FDA.GOV
Http://www.ahrq.gov/data/hcupnet.htm
http://www.ama-assn.org/sci-pubs/amnews/pick_98/anna0713.htm
Federal Register
Vol. 65, no. 247
Office of the Federal Register, National Archives and Records Administration
2000-12-22
continuing
daily
deposited
born digital
595 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2000-12-22
P0b002ee1809fea8f
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
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https://www.govinfo.gov/app/details/FR-2000-12-22
https://www.govinfo.gov/content/pkg/FR-2000-12-22/pdf/FR-2000-12-22.pdf
https://www.govinfo.gov/content/pkg/FR-2000-12-22/xml/FR-2000-12-22.xml
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80733
81319
DGPO
2010-09-24
2023-05-05
FR-2000-12-22
machine generated
eng
FR
FR-2000-12-22
65
247