{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Best Practices in Developing Proprietary Names for Human Prescription Drug Products.\" This document provides guidance to sponsors on the development and selection of proposed proprietary names. This guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations and provides a voluntary framework for evaluating proposed proprietary names before submitting them for FDA review. This guidance finalizes the draft guidance issued in May 2014 entitled \"Best Practices in Developing Proprietary Names for the Drugs.\"","action":"Notice of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/2020/12/09/2020-27058.html","cfr_references":[],"citation":"85 FR 79189","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 9, 2020","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0622"],"dockets":[],"document_number":"2020-27058","effective_on":null,"end_page":79190,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/12/09/2020-27058.xml","html_url":"https://www.federalregister.gov/documents/2020/12/09/2020-27058/best-practices-in-developing-proprietary-names-for-human-prescription-drug-products-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-27058?publication_date=2020-12-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-12-09/2020-27058/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":869,"last_updated":"2026-10-23 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-12-09/pdf/2020-27058.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-27058.pdf?1607435134","publication_date":"2020-12-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/12/09/2020-27058.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-0622","supporting_documents_count":0,"docket_id":"FDA-2014-D-0622","document_id":"FDA-2014-D-0622-0020","regulation_id_number":null,"title":"Best Practices in Developing Proprietary Names for Drugs","checked_regulationsdotgov_at":"2020-12-11T04:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":79189,"subtype":null,"title":"Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability","toc_doc":"Best Practices in Developing Proprietary Names for Human Prescription Drug Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}