{"abstract":"The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking to request comment on whether to initiate a rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), regarding when an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug product.","action":"Advance notice of proposed rulemaking.","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/2005/09/01/05-17390.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"70 FR 52050","comment_url":null,"comments_close_on":"2005-11-01","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by November 1, 2005.","disposition_notes":null,"docket_ids":["Docket No. 2005N-0345"],"dockets":[],"document_number":"05-17390","effective_on":null,"end_page":52051,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/09/01/05-17390.xml","html_url":"https://www.federalregister.gov/documents/2005/09/01/05-17390/drug-approvals-circumstances-under-which-an-active-ingredient-may-be-simultaneously-marketed-in-both","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-17390?publication_date=2005-09-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-09-01/05-17390/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":436,"last_updated":"2026-10-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-09-01/pdf/05-17390.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-09-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/09/01/05-17390.txt","regulation_id_number_info":{"0910-AF72":null},"regulation_id_numbers":["0910-AF72"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T17:04:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52050,"subtype":null,"title":"Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product","toc_doc":"Drug approvals; circumstances under which an active ingredient may be marketed in both prescription and over-the-counter products","toc_subject":"Human drugs:","topics":[],"type":"Proposed Rule","volume":70}