federal_register: 2014-15370
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-15370 | Draft Guidance for Industry on Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Current Good Manufacturing Practice--Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act." This draft guidance describes FDA's current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in accordance with provisions added by the Drug Quality and Security Act (DQSA). FDA is also soliciting public input on specific potential alternative approaches regarding certain CGMP requirements. These potential approaches are explained in detail in the draft guidance. | 2014-07-02 | 2014 | 7 | https://www.federalregister.gov/documents/2014/07/02/2014-15370/draft-guidance-for-industry-on-current-good-manufacturing-practice-interim-guidance-for-human-drug | https://www.govinfo.gov/content/pkg/FR-2014-07-02/pdf/2014-15370.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Current Good Manufacturing Practice--Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C... |