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2013-12-04
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Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations
Proposed Rules
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D09002ee1bdc8ba6a
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination.
78 FR 72840
https://www.govinfo.gov/app/details/FR-2013-12-04/2013-28980
2013-28980
fr04de13-13
4160-01-P
Docket No. FDA-2013-N-1523
https://www.govinfo.gov/app/details/FR-2013-12-04/2013-28980
https://www.govinfo.gov/content/pkg/FR-2013-12-04/html/2013-28980.htm
https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/2013-28980.pdf
2 p.
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78 FR 72840
Code of Federal Regulations
Title 21 Chapter
21 CFR Chapter
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations; Federal Register Vol. 78, Issue
PRORULE
2013-28980
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-03-04
Docket No. FDA-2013-N-1523
4160-01-P
2013-28980
Notification; request for nominations.
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination.
Submit written or electronic comments by March 4, 2014.
Marissa Chaet Brykman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002, 301-796-3110.
Drug Products that Present Demonstrable Difficulties for Compounding:
Request for Nominations
,
http://www.regulations.gov
Federal Register
Vol. 78, no. 233
Office of the Federal Register, National Archives and Records Administration
2013-12-04
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296 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2013-12-04
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https://www.govinfo.gov/app/details/FR-2013-12-04
https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/FR-2013-12-04.pdf
https://www.govinfo.gov/content/pkg/FR-2013-12-04/xml/FR-2013-12-04.xml
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