Drugs

Regulatory Policy Information

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Below is a list of compounding policy documents and related materials. To submit comments to these documents, follow the instructions in the Federal Register notice announcing the availability of that document.

Date IssuedTypeTitleStatements
9/25/2018Revised Draft Guidance

Revised Draft Guidance: Insanitary Conditions at Compounding Facilities

Remarks from Anna Abram as prepared for delivery to the 2018 Inter-governmental Meeting on Drug Compounding


 
9/25/2018Final Guidance

Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities

9/25/2018Final Guidance

Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities

9/7/2018

Revised Draft MOU

 

 

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states 
8/27/2018Federal Register NoticeList of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs  
8/1/2018Federal Register NoticeOutsourcing Facility Fee Rates for Fiscal Year 2019NA
5/10/2018 Final Guidance Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry FDA in Brief: FDA issues new policy on what constitutes an outsourcing facility, a key step in implementing the agency’s comprehensive framework for compounding  
3/26/2018Draft Guidance

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry 

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities 
1/18/2018Final GuidanceCompounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act FDA in Brief: 2018 Compounding Policy Priorities Plan
1/18/2018Final GuidanceCompounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
1/18/2018Final GuidanceMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
7/28/2017FR NoticeDrug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketNA
 
1/13/2017Final 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
1/13/2017Final 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)

1/12/2017Final GuidanceRepackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities   FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products  
12/30/2016Final GuidanceElectronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 191KB) NA
12/28/2016Final Guidance

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

FDA issues guidance on prescription requirement under section 503A
12/15/2016Proposed Rule

List of Bulk Drug Substances that can be used to Compound Drug Products

FDA proposes six bulk drug substances for inclusion on the 503A bulks list 
10/17/2016Proposed 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 
10/6/2016Final 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
6/9/2016Final GuidancePharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB)N/A
4/15/2016Draft Guidance

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

FDA issues three new draft guidances related to compounding of human drugs 
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

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

N/A
8/12/2015Final Guidance

Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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 DocketFDA Establishes Public Docket on Drug Compounding
11/21/2014Final 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
11/21/2014Final Guidance

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

7/1/2014Draft 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

 

Page Last Updated: 10/01/2018
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