{"description":"Documents matching '503A', published on or after 04/01/2026, and from Food and Drug Administration","count":8,"total_pages":1,"results":[{"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":"Reporting Burden \n 1 \n  \n 2 \n \n \n Information collection activity in sections <span class=\"match\">503A</span> and 503B of the FD&amp;C Act \n \n Number of\n respondents \n \n \n Number of\n responses per \n respondent \n \n \n Total annual\n responses \n \n \n Average burden\n per response \n \n Total hours \n \n \n 503B AERs \n 55 \n 1 \n 55 \n 1.10 \n 61 \n \n \n 503B Recordkeeping AERs \n 55 \n 1 \n 55 \n 16 \n 880 \n \n \n <span class=\"match\">503A</span> Reporting \n 45 \n 197.3111 \n 8,879 \n 0.87 \n 7,725 \n \n \n <span class=\"match\">503A</span> Recordkeeping \n 45 \n 2 \n 90 \n 1 \n 90 \n \n \n <span class=\"match\">503A</span> Disclosure (MOU) \n 1 \n 1 \n 1 \n 1 \n 1 \n \n \n Outsourcing facility drug product"},{"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":"Secretary under section <span class=\"match\">503A</span>(c) of the FD&amp;C Act (the <span class=\"match\">503A</span> Bulks List) (see section <span class=\"match\">503A</span>(b)(1)(A)(i) of the FD&amp;C Act). \n \n Agenda: \n FDA, invited attendees, and the public will be able to attend the meeting in-person at FDA's White Oak Campus (see \n ADDRESSES \n ). The meeting presentations will also be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On July 23, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the <span class=\"match\">503A</span> Bulks List: BPC-157-related"},{"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":"this vulnerable patient population. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. \n FDA has determined that temporary enforcement policies for both pharmacy compounders operating under Section <span class=\"match\">503A</span> of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 353a) and for outsourcing facilities registered under Section 503B of the FD&amp;C Act (21 U.S.C. 353b) are needed to help ensure that treatment options for neonates remain available to hospitals and health"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products","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":"2026-13346","html_url":"https://www.federalregister.gov/documents/2026/07/01/2026-13346/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-01/pdf/2026-13346.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13346.pdf?1782823521","publication_date":"2026-07-01","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":"various tasks that may be performed by authorized dispensers in its active collection inventory including OMB control numbers 0910-0800 (Human Drug Compounding Under Sections <span class=\"match\">503A</span> and 503B of the Federal Food, Drug, and Cosmetic Act); 0910-0806 (Pharmaceutical Distribution Supply Chain); and 0910-0858 (Human Drug Compounding, Repackaging, and Related Activities Regarding Sections <span class=\"match\">503A</span> and 503B of the Federal Food, Drug, and Cosmetic Act); and \n • FDA believes that the advent of technology has facilitated, not prolonged, the effort necessary in satisfying"},{"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":"responsibilities as they relate to compounding drugs for human use and, as required, any other product for which FDA has regulatory responsibility. \n The Committee shall provide advice on scientific, technical, and medical issues concerning drug compounding under sections <span class=\"match\">503A</span> and 503B of the Federal Food, Drug, and Cosmetic 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. \n The Committee shall consist of a core of at least 10"},{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","type":"Notice","abstract":"The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.","document_number":"2026-16716","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16716/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16716.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16716.pdf?1786711513","publication_date":"2026-08-17","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":"Processes \n 0910-0738 \n 6/30/2029 \n \n \n Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools \n 0910-0756 \n 5/31/2029 \n \n \n Animal Food and Egg Regulatory Program Standards \n 0910-0760 \n 5/31/2029 \n \n \n Human Drug Compounding Under Sections <span class=\"match\">503A</span> and 503B of the Federal Food, Drug, and Cosmetic Act \n 0910-0800 \n 5/31/2029 \n \n \n Medical Device Accessories \n 0910-0823 \n 3/31/2029 \n \n \n Data To Support Social and Behavioral Research as Used by the Food and Drug Administration \n 0910-0847 \n 5/31/2029 \n \n \n Generic Clearance"},{"title":"Request for Nominations for Individuals and Consumer Organizations for Advisory Committees","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committees selected without regard to race, color, national origin, religion, age, or sex.","document_number":"2026-20065","html_url":"https://www.federalregister.gov/documents/2026/10/01/2026-20065/request-for-nominations-for-individuals-and-consumer-organizations-for-advisory-committees","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-01/pdf/2026-20065.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20065.pdf?1790772309","publication_date":"2026-10-01","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":"for use in the treatment of neurologic diseases and makes appropriate recommendations to the Commissioner. \n Q. Pharmacy Compounding Advisory Committee \n The Committee reviews and evaluates scientific, technical, and medical issues concerning drug compounding under sections <span class=\"match\">503A</span> and 503B of the FD&amp;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. The Committee may consider the quality and relevance of FDA's research program"},{"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":"Outsourcing facilities may or may not obtain prescriptions for identified individual patients and can, therefore, distribute compounded drugs to healthcare practitioners for “office stock,” to hold in their offices in advance of patient need.\n 4 \n \n \n \n \n 2 \n  Compare section <span class=\"match\">503A</span>(a) of the FD&amp;C Act (21 U.S.C. 353a(a)) (exempting drugs compounded in accordance with that section from CGMP requirements) with section 503B(a) of the FD&amp;C Act (not providing an exemption from CGMP requirements).\n \n \n \n \n 3 \n  Section 503B(b)(4) and (5) of the FD&amp;C"}]}