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2018-02-08
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Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Rules and Regulations
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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 the Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
81 FR 37500
https://www.govinfo.gov/app/details/FR-2016-06-10/2016-13798
2016-13798
fr10jn16-7
4164-01-P
Docket No. FDA-2015-D-3539
https://www.govinfo.gov/app/details/FR-2016-06-10/2016-13798
https://www.govinfo.gov/content/pkg/FR-2016-06-10/html/2016-13798.htm
https://www.govinfo.gov/content/pkg/FR-2016-06-10/pdf/2016-13798.pdf
3 p.
37500
37502
81 FR 37500
Code of Federal Regulations
Title 21 Chapter
21 CFR Chapter
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
RULE
2016-13798
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-3539
4164-01-P
2016-13798
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Submit electronic or written comments on Agency guidances at any time.
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110.
Guidance for Industry:
Interim Policy on Compounding Using Bulk Drug Substances under the Federal Food, Drug, and Cosmetic Act
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 112
Office of the Federal Register, National Archives and Records Administration
2016-06-10
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585 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-06-10
P0b002ee1985bb07a
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr10jn16
https://www.govinfo.gov/app/details/FR-2016-06-10
https://www.govinfo.gov/content/pkg/FR-2016-06-10/pdf/FR-2016-06-10.pdf
https://www.govinfo.gov/content/pkg/FR-2016-06-10/xml/FR-2016-06-10.xml
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2018-02-08
2023-04-29
FR-2016-06-10
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FR-2016-06-10
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