Human Drug Compounding Policies and Rules

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
3/19/2024	Proposed Rule	Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act	N/A
10/11/2024	Guidance	Temporary Policies for Compounding Certain Parenteral Drug Products; List for parenteral drug products compounded by pharmacy compounders	Hurricane Helene: Baxter's manufacturing recovery in North Carolina
12/7/2023	Draft Guidance	Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act	N/A
12/7/2023	Draft Guidance	Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act	N/A
8/21/2023	Federal Register Notice	List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B the Federal Food, Drug, and Cosmetic Act	N/A
6/27/2023	Guidance	Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act	N/A
4/6/2023	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	Compounding Safety Information: Quinacrine Hydrochloride
2/9/2023	Guidance	Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act	FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever
11/23/2022	Federal Register Notice	List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B the Federal Food, Drug, and Cosmetic Act	N/A
11/23/2022	Immediately in Effect Guidance	Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act	N/A
10/21/2022	Federal Register Notice	Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products	N/A
1/21/2022	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 Roundup: January 28, 2022
10/6/2021	Revised Draft Guidance	Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act	FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs
8/9/2021	Federal Register Notice	Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out of State Distribution of Compounded Human Drug Products	N/A
3/23/2021	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 Provides Preliminary Assessment on Five Bulk Drug Substances for Use by Outsourcing Facilities
11/6/2020	Final Guidance	Insanitary Conditions at Compounding Facilities Notice of Availability	FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance CDER’s Efforts to Help Improve the Quality of Drug Compounding Include an Ongoing Focus on Insanitary Conditions
10/26/2020	Final MOU	Final Standard Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the [insert STATE BOARD OF PHARMACY or OTHER APPROPRIATE STATE AGENCY] and the U.S. Food and Drug Administration Notice of availability	FDA in Brief: FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States
10/26/2020	Final MOU	Final Standard Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the [insert STATE BOARD OF PHARMACY or OTHER APPROPRIATE STATE AGENCY] and the U.S. Food and Drug Administration	FDA in Brief: FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States
8/19/2020	Federal Register Notice	Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees	N/A
7/30/2020	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 in brief: FDA Proposes Four Bulk Drug Substances for Inclusion, 19 Not to Be Included on 503B Bulks List for Use by Outsourcing Facilities
5/13/2020	Federal Register Notice	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act	FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution, While Preserving Access
4/8/2020	Final Guidance	Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic	N/A
1/22/2020	Revised Draft Guidance	Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities	N/A
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	N/A
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) Notice of Availability	N/A
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 Notice of Availability	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 503Bof 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	N/A
2/15/2019	Final Rule	List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503Athe 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	Final Rule	List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness	N/A
9/25/2018	Final Guidance	Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities	N/A
9/25/2018	Final Guidance	Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities	N/A
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
5/10/2018	Final Guidance	Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry Notice of Availability	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 Notice of Availability	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 Notice of Availability	FDA in Brief: 2018 Compounding Policy Priorities Plan
1/18/2018	Final Guidance	Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Notice of Availability	FDA in Brief: 2018 Compounding Policy Priorities Plan
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	N/A
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) Notice of Availability	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) Notice of Availability	FDA issues final guidances on interim policy for certain bulk drug substances used in compounding
1/12/2017	Final Guidance	Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities Notice of Availability	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) Notice of Availability	N/A
12/28/2016	Final Guidance	Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Notice of Availability	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 Notice of Availability	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 Notice of Availability	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 Notice of Availability	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 Notice of Availability	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 Notice of Availability	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 Notice of Availability	FDA issues additional guidance for outsourcing facilities that compound sterile human drugs