federal_register: 2022-08092
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08092 | Compounding Animal Drugs From Bulk Drug Substances; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #256 entitled "Compounding Animal Drugs from Bulk Drug Substances." This guidance describes FDA's current thinking about compounding animal drugs from bulk drug substances, identifies our enforcement priorities with respect to drugs compounded from bulk drug substances, and describes circumstances under which FDA generally does not intend to take action against veterinarians or pharmacists in either State- licensed pharmacies or Federal facilities, who compound animal drugs from bulk drug substances. We are also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). | 2022-04-14 | 2022 | 4 | https://www.federalregister.gov/documents/2022/04/14/2022-08092/compounding-animal-drugs-from-bulk-drug-substances-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2022-04-14/pdf/2022-08092.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #256 entitled "Compounding Animal Drugs from Bulk Drug Substances." This guidance describes FDA's current thinking about... |