Thursday, February 25, 2016

FDA Regulatory Policy Information Relating to Compounding found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm

Date IssuedTypeTitleAdditional Information
10/26/2015Final GuidancePharmacy Compounding of HumanDrug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB)N/A 
10/26/2015Draft GuidanceInterim 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
10/26/2015Draft GuidanceInterim 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
10/26/2015Request for NominationsBulk 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 DocketN/A
10/26/2015Request for NominationsBulk 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 DocketN/A
10/8/2015Final Guidance Notice of Availability
8/12/2015Final GuidanceGuidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActNotice of Availability
8/3/2015FR NoticeOutsourcing Facility Fee Rates for Fiscal Year 2016 N/A 
3/6/2015Public DocketCompounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketN/A
2/13/2015Draft MOUDraft 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 
2/13/2015Draft GuidanceRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Notice of Availability
2/13/2015Draft GuidanceMixing, 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Revised Draft Guidance
7/2/2014
Request for Nominations
N/A
7/2/2014
Request for Nominations
N/A
7/2/2014
Proposed Rule
N/A
7/2/2014
Draft Guidance
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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