{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing national standards for the licensing of prescription drug wholesale distributors (\"wholesale distributors\" or \"wholesale drug distributors\") and third-party logistics providers (\"3PLs\"), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.","action":"Proposed 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/2022/02/04/2022-01929.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"10","title":21},{"chapter":null,"citation_url":null,"part":"12","title":21},{"chapter":null,"citation_url":null,"part":"16","title":21},{"chapter":null,"citation_url":null,"part":"205","title":21}],"citation":"87 FR 6708","comment_url":null,"comments_close_on":"2022-06-06","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by June 6, 2022. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 7, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1663"],"dockets":[{"supporting_documents":[{"title":"Ref 18 - Economic Analysis RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0022"},{"title":"Ref 17 - NABP 5 rule RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0021"},{"title":"Ref 16 - PDMA report to Congress RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0020"},{"title":"Ref 15 - PIC-S RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0019"},{"title":"Ref 14 - WHO good distribution practices RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0018"},{"title":"Ref 13 - HDA model 3PL standards RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0017"},{"title":"Ref 12 - NABP Model state rules RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0016"},{"title":"Ref 11 - DOJ 5-2014 guilty pleas drug diversion RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0015"},{"title":"Ref 10 - DOJ 5-2015 indictments RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0014"},{"title":"Ref 9 - NABP 7-2013 report RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0013"}],"agency_name":"FDA","documents":[{"comment_count":79,"comment_start_date":"2022-02-04","updated_at":"2023-02-28T17:16:53.999-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1663-0001","allow_late_comments":null,"id":"FDA-2020-N-1663-0001","comment_end_date":"2022-09-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":18,"id":"FDA-2020-N-1663","title":"National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers"}],"document_number":"2022-01929","effective_on":null,"end_page":6757,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/04/2022-01929.xml","html_url":"https://www.federalregister.gov/documents/2022/02/04/2022-01929/national-standards-for-the-licensure-of-wholesale-drug-distributors-and-third-party-logistics","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-01929?publication_date=2022-02-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-04/2022-01929/mods.xml","not_received_for_publication":null,"page_length":50,"page_views":{"count":17622,"last_updated":"2026-06-25 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-01929.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01929.pdf?1643895915","publication_date":"2022-02-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/04/2022-01929.txt","regulation_id_number_info":{"0910-AH11":{"issue":"202204","html_url":"https://www.federalregister.gov/regulations/0910-AH11/national-standards-for-the-licensure-of-wholesale-drug-distributors-and-third-party-logistics-provid","title":"National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&RIN=0910-AH11&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH11"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Ref 18 - Economic Analysis RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0022"},{"title":"Ref 17 - NABP 5 rule RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0021"},{"title":"Ref 16 - PDMA report to Congress RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0020"},{"title":"Ref 15 - PIC-S RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0019"},{"title":"Ref 14 - WHO good distribution practices RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0018"},{"title":"Ref 13 - HDA model 3PL standards RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0017"},{"title":"Ref 12 - NABP Model state rules RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0016"},{"title":"Ref 11 - DOJ 5-2014 guilty pleas drug diversion RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0015"},{"title":"Ref 10 - DOJ 5-2015 indictments RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0014"},{"title":"Ref 9 - NABP 7-2013 report RE National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","document_id":"FDA-2020-N-1663-0013"}],"comments_count":79,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1663","supporting_documents_count":18,"docket_id":"FDA-2020-N-1663","document_id":"FDA-2020-N-1663-0001","regulation_id_number":null,"title":"National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","checked_regulationsdotgov_at":"2023-02-28T22:16:53Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":6708,"subtype":null,"title":"National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","toc_doc":"National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers","toc_subject":null,"topics":["Administrative practice and procedure","Intergovernmental relations","News media","Prescription drugs","Reporting and recordkeeping requirements","Security measures","Warehouses"],"type":"Proposed Rule","volume":87}