{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled \"Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.\" This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products.","action":"Notice of availability.","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/2017/01/13/2017-00723.html","cfr_references":[],"citation":"82 FR 4343","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1524"],"dockets":[],"document_number":"2017-00723","effective_on":null,"end_page":4345,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/13/2017-00723.xml","html_url":"https://www.federalregister.gov/documents/2017/01/13/2017-00723/repackaging-of-certain-human-drug-products-by-pharmacies-and-outsourcing-facilities-final-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-00723?publication_date=2017-01-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-13/2017-00723/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2066,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/2017-00723.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-00723.pdf?1484228797","publication_date":"2017-01-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/13/2017-00723.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-1524","supporting_documents_count":0,"docket_id":"FDA-2014-D-1524","regulation_id_number":null,"title":"Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities","checked_regulationsdotgov_at":"2017-02-02T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4343,"subtype":null,"title":"Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability","toc_doc":"Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}