{"description":"Documents matching '503A bulk drug substances list' and from Food and Drug Administration","count":63,"total_pages":4,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bagencies%5D%5B%5D=food-and-drug-administration&conditions%5Bterm%5D=503A+bulk+drug+substances+list&format=json&page=2","results":[{"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":"following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/MOTs-C acetate). The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the"},{"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":"following bulk drug substances being considered for inclusion on the 503A Bulks List: AOD-9604-related bulk drug substances (AOD-9604 acetate, and AOD-9604 (free base)), CJC-1295-related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate, CJC-1295 with drug affinity complex (DAC) (free base), CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate)), and Thymosin alpha-1-related bulk drug substances (Thymosin alpha-1 acetate, and Thymosin alpha-1 (free base)). The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances"},{"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":"following bulk drug substances being considered for inclusion on the 503A Bulks List: ibutamoren mesylate, L-theanine, ipamorelin-related bulk drug substances (ipamorelin acetate and ipamorelin (free base)), and kisspeptin-10. The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the nominators of these substances will be invited to make a short presentation supporting the nomination.\n \n \n \n \n \n Bulk drug\n substance \n \n Uses"},{"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":"decided not to place on the 503B Bulks List. This list is available at \n https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list. \n FDA will only place a bulk drug substance on the 503B Bulks List when we have determined there is a clinical need for outsourcing facilities to compound drug products using the bulk drug substance. If a clinical need to compound drug products using the bulk drug substance has not been demonstrated, based on the information submitted by the nominator and any other information considered by the Agency"},{"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":"for compounding drug products using certain bulk drug substances that are not eligible for use in compounding under section 503A of the FD&C Act because they are not the subject of an applicable USP or NF monograph, components of FDA-approved drug products, or on the 503A bulks list at § 216.23(a) (21 CFR 216.23(a)). One of these conditions is that the bulk drug substance appears in Category 1. As described in the guidance, FDA does not intend to categorize bulk drug substances nominated for inclusion on the 503A bulks list on or after the publication"},{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under section 503A of the Federal Food, Drug, and Cosmetic Act\" (draft guidance or 2023 503A Interim Policy Draft Guidance) to describe FDA's interim policy regarding the use of bulk drug substances by human drug compounders that are not registered with FDA as outsourcing facilities 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 draft guidance, when finalized, will replace the guidance for industry entitled, \"Interim Policy on Compounding Using Bulk Drug Substances under section 503A of the Federal Food, Drug, and Cosmetic Act\" issued in January 2017 (2017 503A Interim Policy Guidance).","document_number":"2023-26886","html_url":"https://www.federalregister.gov/documents/2023/12/07/2023-26886/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-2023-12-07/pdf/2023-26886.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-26886.pdf?1701870338","publication_date":"2023-12-07","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":"SUMMARY: \n The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under section 503A of the Federal Food, Drug, and Cosmetic Act” (draft guidance or 2023 503A Interim Policy Draft Guidance) to describe FDA's interim policy regarding the use of bulk drug substances by human drug compounders that are not registered with FDA as outsourcing facilities while FDA develops the list of bulk drug substances that can be used in compounding"},{"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 (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and is not including on the list at this time: ephedrine sulfate and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.","document_number":"2023-17881","html_url":"https://www.federalregister.gov/documents/2023/08/21/2023-17881/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-2023-08-21/pdf/2023-17881.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-17881.pdf?1692362726","publication_date":"2023-08-21","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":"that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services (the Secretary) identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act","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 information collection associated with Agency guidance documents pertaining to pharmacies, outsourcing facilities, and other entities with regard to human drug compounding, repackaging, and related activities.","document_number":"2024-12783","html_url":"https://www.federalregister.gov/documents/2024/06/12/2024-12783/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-12/pdf/2024-12783.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-12783.pdf?1718109922","publication_date":"2024-06-12","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":"essentially a copy if the FDA-approved radiopharmaceutical is on FDA's drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of compounding and distribution. If the facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA's drug shortage list, the facility should maintain documentation (\n e.g., \n a notation on the order for the compounded drug) regarding the status of the drug on FDA's drug shortage list at the time of compounding, distribution, and dispensing.\n \n B"},{"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 (APIs)) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and is including on the list at this time: quinacrine hydrochloride (HCl) to compound drug products for oral use only. This notice also identifies 10 bulk drug substances that FDA has considered and is not including on the list at this time: hydroxyzine HCl, mannitol, methacholine chloride, metoclopramide HCl, nalbuphine HCl, potassium acetate, procainamide HCl, sodium bicarbonate, sodium nitroprusside, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.","document_number":"2023-07237","html_url":"https://www.federalregister.gov/documents/2023/04/06/2023-07237/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-2023-04-06/pdf/2023-07237.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07237.pdf?1680698733","publication_date":"2023-04-06","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":"that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services (the Secretary) identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section"},{"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 or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List to compound three categories of compounded drug products: arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with FDA-approved, single-ingredient arginine HCl for intravenous use. This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: etomidate, furosemide, and rocuronium bromide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2022-25549","html_url":"https://www.federalregister.gov/documents/2022/11/23/2022-25549/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-2022-11-23/pdf/2022-25549.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-25549.pdf?1669124731","publication_date":"2022-11-23","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":"conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section 506E"},{"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 (i.e., active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies four bulk drug substances that FDA has considered and is including on the list at this time: Diphenylcyclopropenone (DPCP) for topical use only, glycolic acid for topical use only in concentrations up to 70 percent, squaric acid dibutyl ester (SADBE) for topical use only, and trichloroacetic acid (TCA) for topical use only. This notice also identifies eight bulk drug substances that FDA has considered and is not including on the list at this time: diazepam, dipyridamole, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, and sodium thiosulfate (except for topical administration). Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.","document_number":"2022-01558","html_url":"https://www.federalregister.gov/documents/2022/01/27/2022-01558/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-2022-01-27/pdf/2022-01558.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01558.pdf?1643204727","publication_date":"2022-01-27","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":"that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) The bulk drug substance appears on a list established by the Secretary of Health and Human Services (the Secretary) identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory 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":"2022-09797","html_url":"https://www.federalregister.gov/documents/2022/05/06/2022-09797/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-06/pdf/2022-09797.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-09797.pdf?1651754744","publication_date":"2022-05-06","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":"appear on a list developed by the Secretary through regulations issued by the Secretary under section 503A(c) of the FD&C Act (the 503A Bulks List) (see section 503A(b)(1)(A)(i) of the FD&C Act). \n One of the conditions that must be satisfied to qualify for the exemptions under section 503A or section 503B of the FD&C Act is that the drug that is compounded does not appear on a list published by the Secretary of drugs that have been withdrawn or removed from the market because such drug products or components of such drug products have"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and proposes to include on the 503B Bulks List: Quinacrine hydrochloride (\"quinacrine\"). This notice identifies four bulk drug substances that FDA has considered and proposes not to include on the list: Bromfenac sodium, mitomycin-C, nepafenac, and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and may be the subject of future notices.","document_number":"2021-06060","html_url":"https://www.federalregister.gov/documents/2021/03/24/2021-06060/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-the-federal-food-drug-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-24/pdf/2021-06060.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-06060.pdf?1616503533","publication_date":"2021-03-24","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":"conditions that must be met for a drug product compounded by an outsourcing facility to qualify for exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) The bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding 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":"2021-17996","html_url":"https://www.federalregister.gov/documents/2021/08/23/2021-17996/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-08-23/pdf/2021-17996.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-17996.pdf?1629463535","publication_date":"2021-08-23","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":"essentially a copy if the FDA-approved radiopharmaceutical is on FDA's drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of compounding and distribution. If the facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA's drug shortage list, the facility should maintain documentation (\n e.g., \n a notation on the order for the compounded drug) regarding the status of the drug on FDA's drug shortage list at the time of compounding, distribution, and dispensing.\n \n Radiopharmaceutical"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding 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 associated with Agency guidance documents pertaining to pharmacies, outsourcing facilities, and other entities with regard to human drug compounding, repackaging, and related activities.","document_number":"2021-08943","html_url":"https://www.federalregister.gov/documents/2021/04/29/2021-08943/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-29/pdf/2021-08943.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-08943.pdf?1619613930","publication_date":"2021-04-29","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":"essentially a copy if the FDA-approved radiopharmaceutical is on FDA's drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of compounding and distribution. If the facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA's drug shortage list, the facility should maintain documentation (\n e.g., \n a notation on the order for the compounded drug) regarding the status of the drug on FDA's drug shortage list at the time of compounding, distribution, and dispensing.\n \n Radiopharmaceutical"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee. The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2021-09621","html_url":"https://www.federalregister.gov/documents/2021/05/07/2021-09621/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-07/pdf/2021-09621.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-09621.pdf?1620305122","publication_date":"2021-05-07","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":"appear on a list developed by the Secretary through regulations issued by the Secretary under section 503A(c) of the FD&C Act (the “503A Bulks List”) (see section 503A(b)(1)(A)(i) of the FD&C Act). \n One of the conditions that must be satisfied to qualify for the exemptions under section 503A or section 503B of the FD&C Act is that the drug that is compounded does not appear on a list published by the Secretary of drugs that have been withdrawn or removed from the market because such drug products or components of such drug products have"},{"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 or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies four bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List: Diphenylcyclopropenone (DPCP), glycolic acid, squaric acid dibutyl ester (SADBE), and trichloroacetic acid (TCA). This notice also identifies 19 bulk drug substances that FDA has considered and proposes not to include on the list: Diazepam, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, hydroxyzine HCl, ketorolac tromethamine, labetalol HCl, mannitol, metoclopramide HCl, moxifloxacin HCl, nalbuphine HCl, polidocanol, potassium acetate, procainamide HCl, sodium nitroprusside, sodium thiosulfate, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and may be the subject of future notices.","document_number":"2020-16649","html_url":"https://www.federalregister.gov/documents/2020/07/31/2020-16649/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-2020-07-31/pdf/2020-16649.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-16649.pdf?1596113148","publication_date":"2020-07-31","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":"on the 503B Bulks List. FDA will only place a bulk drug substance on the 503B Bulks List where it has determined there is a clinical need for outsourcing facilities to compound drug products using the bulk drug substance. If a clinical need to compound drug products using the bulk drug substance has not been demonstrated, based on the information submitted by the nominator and any other information considered by the Agency, FDA will not place a bulk drug substance on the 503B Bulks List. \n \n FDA intends to evaluate bulk drug substances nominated for"},{"title":"Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (the Committee), Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs.","document_number":"2020-13042","html_url":"https://www.federalregister.gov/documents/2020/06/17/2020-13042/request-for-nominations-for-voting-members-on-a-public-advisory-committee-pharmacy-compounding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-17/pdf/2020-13042.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-13042.pdf?1592311536","publication_date":"2020-06-17","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":"concerning human drug compounding under sections 503A and 503B of the FD&C Act (21 U.S.C 353a and 353b), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. \n In implementing sections 503A and section 503B of the FD&C Act, the Agency may consult the Committee on: (1) Drug products for inclusion on a list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have"},{"title":"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","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or Agency) has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. This proposed rule would amend that list by placing five additional bulk drug substances on the list. This proposed rule also identifies 26 bulk drug substances that FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.","document_number":"2019-18951","html_url":"https://www.federalregister.gov/documents/2019/09/05/2019-18951/amendments-to-the-list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-09-05/pdf/2019-18951.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-18951.pdf?1567601117","publication_date":"2019-09-05","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":"or NF drug substance monograph, does not satisfy the condition regarding bulk drug substances in section 503A(b)(1)(A)(i)(I) of the FD&C Act. Such a substance may only be used as a bulk drug substance under section 503A of the FD&C Act if it is a component of an FDA-approved drug product or is on the 503A Bulks List.\n \n \n On February 19, 2019, FDA published a final rule establishing the criteria for evaluating substances for inclusion on the 503A Bulks List, placing six substances on the list, and identifying four other substances that were"},{"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 or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies nine bulk drug substances that FDA has considered and is proposing not to include on the list: Dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.","document_number":"2019-18932","html_url":"https://www.federalregister.gov/documents/2019/09/03/2019-18932/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-2019-09-03/pdf/2019-18932.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-18932.pdf?1567169125","publication_date":"2019-09-03","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":"the 503B Bulks List. FDA will only place a bulk drug substance on the 503B Bulks List where it has determined there is a clinical need for outsourcing facilities to compound drug products using the bulk drug substance. If a clinical need to compound drug products using the bulk drug substance has not been demonstrated, based on the information submitted by the nominator and any other information considered by the Agency, FDA will not place a bulk drug substance on the 503B Bulks List. \n \n FDA intends to evaluate the bulk drug substances nominated"}]}