{"abstract":"The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.","action":"Final rule.","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/2016/08/31/2016-20471.html","cfr_references":[{"chapter":null,"citation_url":null,"part":20,"title":21},{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":207,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":514,"title":21},{"chapter":null,"citation_url":null,"part":515,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21},{"chapter":null,"citation_url":null,"part":607,"title":21},{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"81 FR 60170","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective on November 29, 2016. See section IV for compliance dates.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-N-0464 (formerly Docket No. 2005N-0403)"],"dockets":[],"document_number":"2016-20471","effective_on":"2016-11-29","end_page":60224,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/31/2016-20471.xml","html_url":"https://www.federalregister.gov/documents/2016/08/31/2016-20471/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-20471?publication_date=2016-08-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-31/2016-20471/mods.xml","not_received_for_publication":null,"page_length":55,"page_views":{"count":25955,"last_updated":"2026-08-26 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-31/pdf/2016-20471.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-20471.pdf?1472561126","publication_date":"2016-08-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/31/2016-20471.txt","regulation_id_number_info":{"0910-AA49":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AA49/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs-includi","title":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AA49&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AA49"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab 5: Cost Impacts of the Over-the-Counter Pharmaceutical Labeling Rule - 03/05/1999 final report","document_id":"FDA-2005-N-0464-0243"},{"title":"Tab 4: Profile of the Prescription drug wholesaling Industry: Examination of Entities Defining Supply and Demand in Drug Distribution - Final Report dated on 02/12/2001","document_id":"FDA-2005-N-0464-0242"},{"title":"Tab 3: Draft Final Economic Impact Analysis for a Prospective FDA Rule Governing: Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs - on 08/03/2005","document_id":"FDA-2005-N-0464-0241"},{"title":"Tab 2: Letter from FDA/CDER to Eugene S. Peiser & Associates Dated on 08/25/1997","document_id":"FDA-2005-N-0464-0240"},{"title":"Tab 1: Letter from National Association of CHAIN DRUG STORES(NACDS) to FDA/CDER on 09/27/2004","document_id":"FDA-2005-N-0464-0239"},{"title":"Ref2_ERG Revisions 1995 DRAFT FINAL REPORT ECONOMIC THRESHOLD AND REGULATORY FLEXIBILITY ASSESSMENT OF PROPOSED CHANGES TO THE CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS FOR MANUFACTURING, PROCESSING, PACKING, OR HOLDING DRUGS\n(21CFR210&211) re Requi","document_id":"FDA-2005-N-0464-0237"},{"title":"Ref1_BLS_wages_May_2014_NAICS325400 - Pharmaceutical and Medicine Manufacturing re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and ","document_id":"FDA-2005-N-0464-0236"},{"title":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that Are Regulated Under a Biologics License Application, and Animal Drugs","document_id":"FDA-2005-N-0464-0235"},{"title":"Shipping Label re Comment from Bristol-Myers Squibb Company","document_id":"FDA-2005-N-0464-0150"},{"title":"Background Material re The Compressed Gas Assaciation (CCA) and the Gases and Welding Distributors Association (GAWDA)","document_id":"FDA-2005-N-0464-0073"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-N-0464","supporting_documents_count":15,"docket_id":"FDA-2005-N-0464","regulation_id_number":null,"title":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs","checked_regulationsdotgov_at":"2016-09-20T06:00:20Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":60170,"subtype":null,"title":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs","toc_doc":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Biologics","Blood","Confidential business information","Courts","Drugs","Freedom of information","Government employees","Human cells and tissue-based products","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}