Drugs

Regulatory Policy Information

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Date Issued Type Title Statements
10/18/2016 Proposed Rule Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness  Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons 
10/6/2016 Final Rule Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons
8/3/2016 Draft Guidance Insanitary Conditions at Compounding Facilities Guidance for Industry (PDF - 95KB) FDA issues draft guidance on insanitary conditions at compounding facilities
7/7/2016 Draft Guidance

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 108KB)

FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
7/7/2016 Draft Guidance

Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 348KB)

6/9/2016 Final 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)

FDA issues final guidances on interim policy for certain bulk drug substances used in compounding
6/9/2016 Final 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)

4/15/2016 Draft Guidance

Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

FDA issues three new draft guidances related to compounding of human drugs
4/15/2016 Draft Guidance

Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act

4/15/2016 Draft Guidance Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice of Availability
10/26/2015 Final Guidance Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB) N/A
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

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

N/A
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

N/A
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 FDA Establishes Public Docket on Drug Compounding
2/13/2015 Draft MOU

Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert STATE] and the U.S. Food and Drug Administration

FDA issues new draft documents related to compounding of human drugs
2/13/2015 Draft Guidance

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

2/13/2015 Draft Guidance

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

11/24/2014 Final Guidance

Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act

FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
11/24/2014 Final Guidance

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

11/24/2014 Revised Draft Guidance

Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities

7/2/2014 Draft Guidance

Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act

FDA outlines expectations for human drug compounders, including registered outsourcing facilities

 

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