federal_register: 2016-31513
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-31513 | Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities." This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals. | 2016-12-29 | 2016 | 12 | https://www.federalregister.gov/documents/2016/12/29/2016-31513/compounding-and-repackaging-of-radiopharmaceuticals-by-state-licensed-nuclear-pharmacies-and-federal | https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31513.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities." This guidance... |