{"description":"Documents matching 'compounding' and from Food and Drug Administration","count":1130,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bagencies%5D%5B%5D=food-and-drug-administration&conditions%5Bterm%5D=compounding&format=json&page=2","results":[{"title":"Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 25, 2028, expiration date.","document_number":"2026-08378","html_url":"https://www.federalregister.gov/documents/2026/04/30/2026-08378/advisory-committee-pharmacy-compounding-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-30/pdf/2026-08378.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08378.pdf?1777466710","publication_date":"2026-04-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Administration (FDA or the Agency) is announcing the renewal of the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 25, 2028, expiration date. \n \n \n DATES: \n The current charter for the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee will expire on April 25, 2026, unless the Commissioner"},{"title":"Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.","document_number":"2026-17580","html_url":"https://www.federalregister.gov/documents/2026/08/28/2026-17580/compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-28/pdf/2026-17580.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17580.pdf?1787834714","publication_date":"2026-08-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"to determine the circumstances surrounding the <span class=\"match\">compounding</span> activity. Except with regard to one proposed item, the routine business records kept by pharmacists who <span class=\"match\">compound</span> animal drugs from BDS who <span class=\"match\">compound</span> animal drugs from BDS, as well as veterinarians prescribing <span class=\"match\">compounded</span> animal drugs within a valid veterinarian-client-patient relationship, should be adequate to ascertain if the circumstances described in the draft guidance exist. \n The draft guidance provides recommendations for the <span class=\"match\">compounding</span> of animal drugs from bulk drug substances at "},{"title":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled \"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates.\" This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.","document_number":"2026-18368","html_url":"https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18368.pdf?1788552907","publication_date":"2026-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Notice of availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled “Temporary Policies for <span class=\"match\">Compounding</span> Certain Starter Parenteral Nutrition Drug Products for Neonates.” This guidance describes the FDA's regulatory and enforcement priorities regarding the <span class=\"match\">compounding</span> of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.","document_number":"2026-10372","html_url":"https://www.federalregister.gov/documents/2026/05/26/2026-10372/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-26/pdf/2026-10372.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10372.pdf?1779453911","publication_date":"2026-05-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"medication tailored to the needs of an individual patient. Although <span class=\"match\">compounded</span> drugs can serve an important medical need for certain patients, they may also present risks. Our <span class=\"match\">compounding</span> program aims to protect patients from unsafe, ineffective, and poor-quality <span class=\"match\">compounded</span> drugs, while preserving access to lawfully-marketed <span class=\"match\">compounded</span> drugs for patients who have a medical need for them.\n \n Respondents to the information collection are those engaged in the practice of human drug <span class=\"match\">compounding</span>. The information collection is intended to account for burden"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2026-07361","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07361.pdf?1776257113","publication_date":"2026-04-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"for a drug product to qualify for the exemptions under section 503A of the FD&amp;C Act is that the licensed pharmacist or licensed physician <span class=\"match\">compounds</span> the drug product using bulk drug substances (as defined in 21 CFR 207.3) that: (1) comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy <span class=\"match\">compounding</span>; (2) if an applicable monograph does not exist, are drug substances that are components of drugs approved by the Secretary of Health and Human"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.","document_number":"2026-17676","html_url":"https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17676.pdf?1787921110","publication_date":"2026-08-31","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 90 \n 1 \n 90 \n 0.5 (30 minutes) \n 45 \n \n \n Request for Small Business Reduction (Form FDA 3908) \n 8 \n 1 \n 8 \n 25 \n 200 \n \n \n Reinspection Fees; Section C. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 12 \n 1 \n 12 \n 0.5 (30 minutes) \n 6 \n \n \n Reconsideration Requests; Section V.B.1. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 1 \n 1 \n 1 \n 1 \n 1 \n \n \n Appeal of Reconsideration Denials; Section V.B.2. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.","document_number":"2025-20773","html_url":"https://www.federalregister.gov/documents/2025/11/24/2025-20773/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20773.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20773.pdf?1763732728","publication_date":"2025-11-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"medication tailored to the needs of an individual patient. Although <span class=\"match\">compounded</span> drugs can serve an important medical need for certain patients, they also present risk. Our <span class=\"match\">compounding</span> program aims to protect patients from unsafe, ineffective, and poor quality <span class=\"match\">compounded</span> drugs, while preserving access to lawfully-marketed <span class=\"match\">compounded</span> drugs for patients who have a medical need for them.\n \n Respondents to the information collection are those engaged in the practice of pharmacy <span class=\"match\">compounding</span>. The information collection is intended to account for burden attributable"},{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","document_number":"2024-31546","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31546/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31546.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31546.pdf?1736171123","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on <span class=\"match\">Compounding</span> Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance describes FDA's interim policy concerning <span class=\"match\">compounding</span> by human drug product <span class=\"match\">compounders</span> that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in <span class=\"match\">compounding</span> under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). This guidance"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping provisions set forth in Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk Substances.","document_number":"2025-07578","html_url":"https://www.federalregister.gov/documents/2025/05/01/2025-07578/agency-information-collection-activities-proposed-collection-comment-request-compounding-animal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-01/pdf/2025-07578.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07578.pdf?1746017117","publication_date":"2025-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"understanding FDA's current thinking about animal drug <span class=\"match\">compounding</span> from bulk substances, our Center for Veterinary Medicine developed GFI #256 entitled “\n <span class=\"match\">Compounding</span> Animal Drugs from Bulk Drug Substances \n ” (\n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-<span class=\"match\">compounding</span>-animal-drugs-bulk-drug-substances \n ). The guidance describes circumstances under which FDA generally does not intend to take enforcement action against pharmacists and veterinarians who <span class=\"match\">compound</span> animal drugs from bulk drug substances.\n \n FDA estimates"},{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","document_number":"2024-31545","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31545/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503b-of-the-federal-food-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31545.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31545.pdf?1736171123","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Policy Guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for <span class=\"match\">compounding</span> a drug product using certain bulk drug substances that are not eligible for use in <span class=\"match\">compounding</span> under section 503B of the FD&amp;C Act because they do not appear on the 503B bulks list and are not used to <span class=\"match\">compound</span> a drug product that appears on FDA's drug shortage list at the time of <span class=\"match\">compounding</span>, distribution, and dispensing. One of these conditions is that the bulk drug substance appears in Category 1. As described"},{"title":"Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 25, 2026, expiration date.","document_number":"2024-16667","html_url":"https://www.federalregister.gov/documents/2024/07/30/2024-16667/advisory-committee-pharmacy-compounding-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-30/pdf/2024-16667.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16667.pdf?1722257121","publication_date":"2024-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Administration (FDA or the Agency) is announcing the renewal of the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the April 25, 2026, expiration date. \n \n \n DATES: \n Authority for the Pharmacy <span class=\"match\">Compounding</span> Advisory Committee will expire on April 25, 2026, unless the Commissioner formally"},{"title":"Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled \"Temporary Policies for Compounding Certain Parenteral Drug Products.\" As of October 10, 2024, pursuant to the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida. In late September 2024, Hurricane Helene had a devastating impact on one of the largest manufacturers of certain intravenous and peritoneal dialysis solutions in the United States. This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain parenteral drug products by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities.","document_number":"2024-23954","html_url":"https://www.federalregister.gov/documents/2024/10/17/2024-23954/temporary-policies-for-compounding-certain-parenteral-drug-products-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-17/pdf/2024-23954.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23954.pdf?1729082726","publication_date":"2024-10-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"continue. Therefore, FDA is issuing this policy to describe the FDA's regulatory and enforcement priorities regarding the <span class=\"match\">compounding</span> of certain parenteral drug products for hospitals by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. \n We are announcing the availability of a guidance for industry entitled “Temporary Policies for <span class=\"match\">Compounding</span> Certain Parenteral Drug Products.” We are issuing this guidance consistent with our good guidance practices (GGP) regulation"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2024-24828","html_url":"https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-25/pdf/2024-24828.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24828.pdf?1729773929","publication_date":"2024-10-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"for a drug product to qualify for the exemptions under section 503A of the FD&amp;C Act is that the licensed pharmacist or licensed physician <span class=\"match\">compounds</span> the drug product using bulk drug substances (as defined in 21 CFR 207.3) that: (1) comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy <span class=\"match\">compounding</span>; (2) if an applicable monograph does not exist, are drug substances that are components of drugs approved by the Secretary of Health and Human"},{"title":"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","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2026-03448","html_url":"https://www.federalregister.gov/documents/2026/02/23/2026-03448/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-23/pdf/2026-03448.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03448.pdf?1771595110","publication_date":"2026-02-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"medication tailored to the needs of an individual patient. Although <span class=\"match\">compounded</span> drugs can serve an important medical need for certain patients, they also present risk. Our <span class=\"match\">compounding</span> program aims to protect patients from unsafe, ineffective, and poor quality <span class=\"match\">compounded</span> drugs, while preserving access to lawfully-marketed <span class=\"match\">compounded</span> drugs for patients who have a medical need for them.\n \n Respondents to the information collection are those engaged in the practice of pharmacy <span class=\"match\">compounding</span>. The information collection is intended to account for burden attributable"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2024-21241","html_url":"https://www.federalregister.gov/documents/2024/09/18/2024-21241/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-18/pdf/2024-21241.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21241.pdf?1726577134","publication_date":"2024-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Act describes the conditions that must be satisfied for drug products <span class=\"match\">compounded</span> in an outsourcing facility to be exempt from: (1) section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements) of the FD&amp;C Act. \n \n One of the conditions that must be satisfied for a drug product to qualify for the exemptions under section 503A of the FD&amp;C Act is that the licensed pharmacist or licensed physician <span class=\"match\">compounds</span> the drug product using bulk drug substances (as defined in 21 CFR 207"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"an outsourcing facility to <span class=\"match\">compound</span> the drug product and (2) the drug product must be <span class=\"match\">compounded</span> using the bulk drug substance. FDA does not interpret supply issues, such as backorders, to be within the meaning of “clinical need” for <span class=\"match\">compounding</span> with a bulk drug substance. Section 503B of the FD&amp;C Act separately provides for <span class=\"match\">compounding</span> from a bulk drug substance under the exemptions discussed above if the drug product <span class=\"match\">compounded</span> from the bulk drug substance is on the FDA drug shortage list at the time of <span class=\"match\">compounding</span>, distribution, and dispensing"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.","document_number":"2024-19870","html_url":"https://www.federalregister.gov/documents/2024/09/05/2024-19870/agency-information-collection-activities-proposed-collection-comment-request-obtaining-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-05/pdf/2024-19870.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-19870.pdf?1725453921","publication_date":"2024-09-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"implement programs to support <span class=\"match\">compounding</span> quality and compliance. One initiative is FDA's <span class=\"match\">Compounding</span> Quality Center of Excellence (Center of Excellence), \n https://www.fda.gov/drugs/human-drug-<span class=\"match\">compounding</span>/<span class=\"match\">compounding</span>-quality-center-excellence, which was \n developed to focus on improving the quality of <span class=\"match\">compounded</span> human prescription drugs to promote patient safety. One of our top priorities is to help ensure that <span class=\"match\">compounded</span> drugs are safe by focusing on quality. FDA, state regulators, pharmacy associations, and <span class=\"match\">compounders</span>, including outsourcing facilities"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Compounding Animal Drugs From Bulk Drug Substances","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2025-14226","html_url":"https://www.federalregister.gov/documents/2025/07/29/2025-14226/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-29/pdf/2025-14226.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14226.pdf?1753706707","publication_date":"2025-07-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"understanding FDA's current thinking about animal drug <span class=\"match\">compounding</span> from bulk substances, our Center for Veterinary Medicine developed GFI #256 entitled “\n <span class=\"match\">Compounding</span> Animal Drugs from Bulk Drug Substances” \n (\n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-<span class=\"match\">compounding</span>-animal-drugs-bulk-drug-substances \n ). The guidance describes circumstances under which FDA generally does not intend to take enforcement action against pharmacists and veterinarians who <span class=\"match\">compound</span> animal drugs from bulk drug substances.\n \n \n In the"},{"title":"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","type":"Proposed Rule","abstract":"The Food and Drug Administration is proposing to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or DDC Lists) under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.","document_number":"2024-05801","html_url":"https://www.federalregister.gov/documents/2024/03/20/2024-05801/drug-products-or-categories-of-drug-products-that-present-demonstrable-difficulties-for-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-20/pdf/2024-05801.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-05801.pdf?1710852315","publication_date":"2024-03-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"difficulties for <span class=\"match\">compounding</span> if bioavailability is challenging to achieve because of the characteristics of the API or <span class=\"match\">compounded</span> formulation such as low permeability or low solubility. Examples of drug products for which consistent bioavailability is difficult to achieve include Biopharmaceutics Classification System Class 2 drugs (\n e.g., \n naproxen, lansoprazole, rifampin, and carbamazepine) and Class 4 drugs (\n e.g., \n azathioprine, clarithromycin, oxcarbazepine, and modafinil).\n \n 5. <span class=\"match\">Compounding</span> Process Complexity \n \n <span class=\"match\">Compounding</span> process complexity"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2025-07557","html_url":"https://www.federalregister.gov/documents/2025/05/01/2025-07557/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-01/pdf/2025-07557.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07557.pdf?1746017115","publication_date":"2025-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"implement programs to support <span class=\"match\">compounding</span> quality and compliance. One initiative is FDA's <span class=\"match\">Compounding</span> Quality Center of Excellence (Center of Excellence), \n https://www.fda.gov/drugs/human-drug-<span class=\"match\">compounding</span>/<span class=\"match\">compounding</span>-quality-center-excellence, which was \n developed to focus on improving the quality of <span class=\"match\">compounded</span> human prescription drugs to promote patient safety. One of our top priorities is to help ensure that <span class=\"match\">compounded</span> drugs are safe by focusing on quality. FDA, state regulators, pharmacy associations, and <span class=\"match\">compounders</span>, including outsourcing facilities"}]}