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2017-07-28
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Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
Notices
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D09002ee1bdbbd5ec
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 developing a list of drug products and categories of drug products that present demonstrable difficulties for compounding (the Difficult to Compound List). The Agency previously solicited nominations for this list and received approximately 71 unique nominations. FDA is establishing a new public docket so that interested parties can nominate drug products or categories of drug products that were not previously nominated for inclusion on the Difficult to Compound List, resubmit previous nominations with additional supporting information, or submit comments.
82 FR 35214
https://www.govinfo.gov/app/details/FR-2017-07-28/2017-15900
2017-15900
fr28jy17-83
4164-01-P
Docket No. FDA-2017-N-2562
https://www.govinfo.gov/app/details/FR-2017-07-28/2017-15900
https://www.govinfo.gov/content/pkg/FR-2017-07-28/html/2017-15900.htm
https://www.govinfo.gov/content/pkg/FR-2017-07-28/pdf/2017-15900.pdf
3 p.
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82 FR 35214
Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Federal Register Vol. 82, Issue
NOTICE
2017-15900
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-N-2562
4164-01-P
2017-15900
Notice; establishment of public docket.
The Food and Drug Administration (FDA or Agency) is developing a list of drug products and categories of drug products that present demonstrable difficulties for compounding (the Difficult to Compound List). The Agency previously solicited nominations for this list and received approximately 71 unique nominations. FDA is establishing a new public docket so that interested parties can nominate drug products or categories of drug products that were not previously nominated for inclusion on the Difficult to Compound List, resubmit previous nominations with additional supporting information, or submit comments.
Nominations for the Difficult to Compound List and comments may be submitted to this docket at any time.
Pawanprit Singh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5206, Silver Spring, MD 20993-0002, 240- 402-8866.
Docket Establishments:
Drug Products That Present Demonstrable Difficulties for Compounding Under Federal Food, Drug, and Cosmetic Act
,
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM486146.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 144
Office of the Federal Register, National Archives and Records Administration
2017-07-28
continuing
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386 p.
Table of Contents:
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GS 4.107:
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https://www.govinfo.gov/app/details/FR-2017-07-28
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https://www.govinfo.gov/app/details/FR-2017-07-28
https://www.govinfo.gov/content/pkg/FR-2017-07-28/pdf/FR-2017-07-28.pdf
https://www.govinfo.gov/content/pkg/FR-2017-07-28/xml/FR-2017-07-28.xml
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