federal_register: 2018-20901

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-20901 Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities." Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA generally intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA generally does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals. 2018-09-26 2018 9 https://www.federalregister.gov/documents/2018/09/26/2018-20901/compounding-and-repackaging-of-radiopharmaceuticals-by-outsourcing-facilities-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2018-09-26/pdf/2018-20901.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities." Specifically, this guidance sets forth FDA's...  

Links from other tables