federal_register: 2014-27691
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-27691 | Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance | Notice | The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled "Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they have compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system. This revised draft guidance supersedes a draft guidance entitled "Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act." | 2014-11-24 | 2014 | 11 | https://www.federalregister.gov/documents/2014/11/24/2014-27691/electronic-product-reporting-for-human-drug-compounding-outsourcing-facilities-draft-guidance | https://www.govinfo.gov/content/pkg/FR-2014-11-24/pdf/2014-27691.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled "Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and... |