{"description":"Documents matching '503A', published on or after 07/25/2026, and from Food and Drug Administration","count":3,"total_pages":1,"results":[{"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; 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"}]}