{"abstract":"The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the \"340B Drug Pricing Program\" or the \"340B Program.\" This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2017/01/05/2016-31935.html","cfr_references":[{"chapter":null,"citation_url":null,"part":10,"title":42}],"citation":"82 FR 1210","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 6, 2017.","disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"2016-31935","effective_on":"2017-03-06","end_page":1230,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/05/2016-31935.xml","html_url":"https://www.federalregister.gov/documents/2017/01/05/2016-31935/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-31935?publication_date=2017-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-05/2016-31935/mods.xml","not_received_for_publication":null,"page_length":21,"page_views":{"count":12217,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-05/pdf/2016-31935.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-31935.pdf?1483537549","publication_date":"2017-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/05/2016-31935.txt","regulation_id_number_info":{"0906-AA89":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0906-AA89/340-b-civil-monetary-penalties-for-manufacturers-and-ceiling-price-regulations","title":"340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0906-AA89&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0906-AA89"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"HHS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HHS-OS-2022-0008","supporting_documents_count":0,"docket_id":"HHS-OS-2022-0008","document_id":"HHS-OS-2022-0008-0499","regulation_id_number":null,"title":"HHS 2022 Archive","checked_regulationsdotgov_at":"2022-05-28T03:30:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":1210,"subtype":null,"title":"340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation","toc_doc":"340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties","toc_subject":null,"topics":["Biologics","Business and industry","Diseases","Drugs","Health","Health care","Health facilities","Hospitals"],"type":"Rule","volume":82}