{"abstract":"FDA is establishing a public docket for interested parties to nominate bulk drug substances or renominate bulk drug substances that were previously nominated without adequate supporting information, for inclusion on a list of bulk drug substances for compounding certain animal drugs without a patient specific prescription (i.e., office stock) for use in nonfood-producing animals or as antidotes for food- producing animals, as described in the draft guidance for industry #256, \"Compounding Animal Drugs from Bulk Drug Substances,\" when that guidance is finalized. Individuals may also comment on bulk drug substances that have been reviewed by FDA and added to this list, or nominations that are currently under FDA review.","action":"Notice; 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/2019/11/20/2019-25140.html","cfr_references":[],"citation":"84 FR 64080","comment_url":"http://www.regulations.gov/commenton/FDA-2018-N-4626-0001","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"You may submit either electronic or written nominations and comments at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-4626"],"dockets":[{"supporting_documents":[{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0025"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0024"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0023"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0022"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0021"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0020"},{"title":"Nomination from Outsourcing Facilities Association","document_id":"FDA-2018-N-4626-0019"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0018"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0017"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0016"}],"agency_name":null,"documents":[{"comment_count":745,"comment_start_date":"2019-11-20","updated_at":"2026-07-18T03:56:37.760-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-4626-0001","allow_late_comments":true,"id":"FDA-2018-N-4626-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":17,"id":"FDA-2018-N-4626","title":"List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations"}],"document_number":"2019-25140","effective_on":null,"end_page":64083,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/11/20/2019-25140.xml","html_url":"https://www.federalregister.gov/documents/2019/11/20/2019-25140/list-of-bulk-drug-substances-for-compounding-office-stock-drugs-for-use-in-nonfood-producing-animals","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-25140?publication_date=2019-11-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-11-20/2019-25140/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":818,"last_updated":"2026-07-27 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-20/pdf/2019-25140.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-25140.pdf?1574171122","publication_date":"2019-11-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/11/20/2019-25140.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0025"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0024"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0023"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0022"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0021"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0020"},{"title":"Nomination from Outsourcing Facilities Association","document_id":"FDA-2018-N-4626-0019"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0018"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0017"},{"title":"Nomination from Wedgewood Pharmacy","document_id":"FDA-2018-N-4626-0016"}],"comments_count":745,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-4626","supporting_documents_count":17,"docket_id":"FDA-2018-N-4626","document_id":"FDA-2018-N-4626-0001","regulation_id_number":null,"title":"List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations","checked_regulationsdotgov_at":"2026-07-19T10:55:04Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2018-N-4626-0001","significant":null,"signing_date":null,"start_page":64080,"subtype":null,"title":"List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations","toc_doc":"List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals","toc_subject":"Requests for Nominations:\n","topics":[],"type":"Notice","volume":84}