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2010-09-23
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Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements; Removal of Regulations for Unit-Dose Packaging Requirements for Dietary Supplements and Drugs
Rules and Regulations
D09002ee1bdeb6aca
D09002ee1bdeb6b41
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 removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron- containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.
68 FR 59714
https://www.govinfo.gov/app/details/FR-2003-10-17/03-26188
03-26188
fr17oc03-7
4160-01-S
Docket Nos. 91P-0186 and 93P-0306
https://www.govinfo.gov/app/details/FR-2003-10-17/03-26188
https://www.govinfo.gov/content/pkg/FR-2003-10-17/html/03-26188.htm
https://www.govinfo.gov/content/pkg/FR-2003-10-17/pdf/03-26188.pdf
2 p.
59714
59715
68 FR 59714
Code of Federal Regulations
Title 21 Part 111
21 CFR Part 111
Code of Federal Regulations
Title 21 Part 310
21 CFR Part 310
Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements; Removal of Regulations for Unit-Dose Packaging Requirements for Dietary Supplements and Drugs; Federal Register Vol. 68, Issue
RULE
03-26188
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-10-17
Docket Nos. 91P-0186 and 93P-0306
4160-01-S
03-26188
Final rule; removal of regulatory provisions in response to court order.
The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron- containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.
This rule is effective October 17, 2003.
Robert J. Moore, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.
Federal Register
Vol. 68, no. 201
Office of the Federal Register, National Archives and Records Administration
2003-10-17
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161 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2003-10-17
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0042-1219
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https://www.govinfo.gov/app/details/FR-2003-10-17
https://www.govinfo.gov/content/pkg/FR-2003-10-17/pdf/FR-2003-10-17.pdf
https://www.govinfo.gov/content/pkg/FR-2003-10-17/xml/FR-2003-10-17.xml
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2010-09-23
2023-05-04
FR-2003-10-17
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FR-2003-10-17
68
201