Date Issued | Type | Title | Additional Information |
10/26/2015 | Final Guidance | Pharmacy Compounding of HumanDrug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB) | N/A |
10/26/2015 | Draft Guidance | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 105KB) | Notice of Availability |
10/26/2015 | Draft Guidance | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 126KB) | Notice of Availability |
10/26/2015 | Request for Nominations | Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | N/A |
10/26/2015 | Request for Nominations | Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | N/A |
10/8/2015 | Final Guidance |
| Notice of Availability |
8/12/2015 | Final Guidance | Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Notice of Availability |
8/3/2015 | FR Notice | Outsourcing Facility Fee Rates for Fiscal Year 2016 | N/A |
3/6/2015 | Public Docket | Compounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | N/A |
2/13/2015 | Draft MOU | Draft Memorandum of Understanding Addressting Certain Distributions of Compounded Human Drug Products Between the State of [insert STATE] and the U.S. Food and Drug Administration | Notice of Availability |
2/13/2015 | Draft Guidance | Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities | Notice of Availability |
2/13/2015 | Draft Guidance | Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application | Notice of Availability |
11/24/2014
|
Final Guidance
|
|
|
11/24/2014
|
Final Guidance
|
|
|
11/24/2014
|
Revised Draft Guidance
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|
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7/2/2014
|
Request for Nominations
|
|
N/A
|
7/2/2014
|
Request for Nominations
|
|
N/A
|
7/2/2014
|
Proposed Rule
|
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N/A
|
7/2/2014
|
Draft Guidance
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|
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12/4/2013
|
Request for Nominations
|
|
N/A
|
12/4/2013
|
Request for Nominations
|
|
N/A
|
12/4/2013
|
Request for Nominations
|
|
N/A
|
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