{"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.","action":"Notice.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/04/06/2023-07237.html","cfr_references":[],"citation":"88 FR 20531","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the notice is published in the Federal Register on April 6, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3240"],"dockets":[{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-04-06","updated_at":"2023-04-06T09:56:45.901-04:00","comment_url":"https://www.regulations.gov/commenton/FDA_FRDOC_0001-12124","allow_late_comments":null,"id":"FDA_FRDOC_0001-12124","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA_FRDOC_0001","title":"Recently Posted FDA Rules and Notices."}],"document_number":"2023-07237","effective_on":null,"end_page":20542,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/04/06/2023-07237.xml","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","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-07237?publication_date=2023-04-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-04-06/2023-07237/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":2276,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-06/pdf/2023-07237.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07237.pdf?1680698733","publication_date":"2023-04-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/04/06/2023-07237.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA_FRDOC_0001","supporting_documents_count":0,"docket_id":"FDA_FRDOC_0001","document_id":"FDA_FRDOC_0001-12124","regulation_id_number":null,"title":"Recently Posted FDA Rules and Notices.","checked_regulationsdotgov_at":"2023-04-07T13:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20531,"subtype":null,"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","toc_doc":"List of Bulk Drug Substances for Which There is a Clinical Need under the Federal Food, Drug, and Cosmetic Act","toc_subject":null,"topics":[],"type":"Notice","volume":88}