Regulatory Policy Information

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 3/11/2024 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compounded by pharmacy compounders Hurricane Helene: Baxter’s manufacturing recovery in North Carolina 12/7/2023 Draft Guidance Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act N/A 12/7/2023 Draft Guidance Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act N/A 8/21/2023 Federal Register Notice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Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act FDA Roundup: January 28, 2022 10/6/2021 Revised Draft Guidance Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act FDA Revises Hospital and Health System Compounding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

Source