{"abstract":"The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination.","action":"Notification; request for nominations.","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/2013/12/04/2013-28980.html","cfr_references":[{"chapter":0,"citation_url":null,"part":null,"title":21}],"citation":"78 FR 72840","comment_url":null,"comments_close_on":"2014-03-04","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by March 4, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1523"],"dockets":[],"document_number":"2013-28980","effective_on":null,"end_page":72841,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/12/04/2013-28980.xml","html_url":"https://www.federalregister.gov/documents/2013/12/04/2013-28980/drug-products-that-present-demonstrable-difficulties-for-compounding-under-sections-503a-and-503b-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-28980?publication_date=2013-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-12-04/2013-28980/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":5511,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/2013-28980.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-28980.pdf?1386001036","publication_date":"2013-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/12/04/2013-28980.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-02-19T05:02:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72840,"subtype":null,"title":"Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations","toc_doc":"Request for Nominations","toc_subject":"Drug Products that Present Demonstrable Difficulties for Compounding:","topics":[],"type":"Proposed Rule","volume":78}