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2010-09-24
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Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products
Rules and Regulations
D09002ee1bdfec9bc
D09002ee1bdfeca37
United States
Department of Health and Human Services
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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 amending its regulations on tamper-resistant packaging to require that all over-the- counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term ``tamper-resistant'' in the labeling of all OTC drug products to ``tamper-evident;'' and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.
63 FR 59463
https://www.govinfo.gov/app/details/FR-1998-11-04/98-29388
98-29388
fr04no98-3
4160-01-F
Docket No. 92N-0314
https://www.govinfo.gov/app/details/FR-1998-11-04/98-29388
https://www.govinfo.gov/content/pkg/FR-1998-11-04/html/98-29388.htm
https://www.govinfo.gov/content/pkg/FR-1998-11-04/pdf/98-29388.pdf
9 p.
59463
59471
63 FR 59463
Code of Federal Regulations
Title 21 Part 211
21 CFR Part 211
Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products; Federal Register Vol. 63, Issue
RULE
98-29388
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1998-12-04
Docket No. 92N-0314
4160-01-F
98-29388
Final rule.
The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the- counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term ``tamper-resistant'' in the labeling of all OTC drug products to ``tamper-evident;'' and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.
Effective December 4, 1998.
Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5640.
Federal Register
Vol. 63, no. 213
Office of the Federal Register, National Archives and Records Administration
1998-11-04
continuing
daily
deposited
born digital
242 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1998-11-04
P0b002ee180a4f535
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr04no98
https://www.govinfo.gov/app/details/FR-1998-11-04
https://www.govinfo.gov/content/pkg/FR-1998-11-04/pdf/FR-1998-11-04.pdf
fdlp
59457
59689
DGPO
2010-09-24
2023-05-06
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FR
FR-1998-11-04
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