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2009-12-10
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Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Rules and Regulations
D09002ee1bdd273d7
D09002ee1bdd27447
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 issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP).''
74 FR 65409
https://www.govinfo.gov/app/details/FR-2009-12-10/E9-29285
E9-29285
FR10DE09-9
4160-01-S
Docket No. FDA-2004-N-0449
https://www.govinfo.gov/app/details/FR-2009-12-10/E9-29285
https://www.govinfo.gov/content/pkg/FR-2009-12-10/html/E9-29285.htm
https://www.govinfo.gov/content/pkg/FR-2009-12-10/pdf/E9-29285.pdf
Drugs
Packaging and Containers
Labeling
Laboratories
Prescription Drugs
Reporting and Recordkeeping Requirements
Warehouses
Current Good Manufacturing Practice
Incorporation by Reference
Positron Emission Tomography Drugs
28 p.
65409
65436
74 FR 65409
Code of Federal Regulations
Title 21 Part 210
21 CFR Part 210
Code of Federal Regulations
Title 21 Part 211
21 CFR Part 211
Code of Federal Regulations
Title 21 Part 212
21 CFR Part 212
Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Federal Register Vol. 74, Issue
RULE
E9-29285
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-12-12
Docket No. FDA-2004-N-0449
4160-01-S
E9-29285
Final rule.
The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP).''
This regulation is effective December 12, 2011. The incorporation by reference of a certain publication listed in the rule is approved by the Director of the Federal Register as of December 12, 2011.
Brenda Uratani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-240-328-7621, e-mail: Brenda.Uratani@fda.hhs.gov.
Drugs
Packaging and Containers
Labeling
Laboratories
Prescription Drugs
Reporting and Recordkeeping Requirements
Warehouses
Current Good Manufacturing Practice
Incorporation by Reference
Positron Emission Tomography Drugs
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
,
Brenda.Uratani@fda.hhs.gov
gt@usp.org
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.usp.org/USPNF/notices
Federal Register
Vol. 74, no. 236
Office of the Federal Register, National Archives and Records Administration
2009-12-10
continuing
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304 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2009-12-10
P0b002ee180129772
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:FR10DE09
https://www.govinfo.gov/app/details/FR-2009-12-10
https://www.govinfo.gov/content/pkg/FR-2009-12-10/pdf/FR-2009-12-10.pdf
https://www.govinfo.gov/content/pkg/FR-2009-12-10/xml/FR-2009-12-10.xml
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DGPO
2009-12-10
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FR-2009-12-10
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FR
FR-2009-12-10
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