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  1. Human Drug Compounding

Regulatory Policy Information

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 Issued Type Title Statements
9/4/2019 Proposed Rule Amendments to the List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act NA
8/30/2019 Federal Register Notice List of Bulk Drug Substances for Which There is a Clinical Need Under 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 drugs using nine bulk drug substances
5/23/2019 Guidance

Guidance Section 503A Bulks List Final Rule Questions and Answers Guidance for Industry (Small Entity Compliance Guide)

NA
7/5/2019 Final Guidance Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency
3/1/2019 Federal Register Notice List of Bulk Drug Substances for which there is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act FDA finalizes guidance on evaluating the Clinical Need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances
3/1/2019 Final Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  
2/15/2019 Final Rule List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A the Federal Food, Drug, and Cosmetic Act FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use
12/10/2018 Federal Register Notice of Public Meeting The Food and Drug Administration’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs
 
12/10/2018 Revised Draft Guidance

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities

12/10/2018 Final Rule

List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness

9/25/2018 Final Guidance Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities  
9/25/2018 Final Guidance Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities  
9/25/2018 Revised 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
9/7/2018

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 
8/27/2018 Federal Register Notice List 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  
8/1/2018 Federal Register Notice Outsourcing Facility Fee Rates for Fiscal Year 2019 NA
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  
1/18/2018 Final 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 FDA in Brief: 2018 Compounding Policy Priorities Plan
1/18/2018 Final Guidance Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
1/18/2018 Final Guidance Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
7/28/2017 FR Notice Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket NA
 
1/13/2017 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
1/13/2017 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)

1/12/2017 Final Guidance Repackaging 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  
12/30/2016 Final Guidance Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 191KB) NA
12/28/2016 Final Guidance

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

FDA issues guidance on prescription requirement under section 503A
10/17/2016 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
6/9/2016 Final Guidance Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 86KB) N/A
4/15/2016 Draft 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  
10/26/2015 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
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
11/21/2014 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
11/21/2014 Final Guidance

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

 

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