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The table below from the website lists all official FDA Guidance Documents and other regulatory guidance. One can search for documents using key words, and narrow or filter search results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.
If you cannot find the document you're looking for here, you can browse separate collections of guidance documents by topic.
This week, we will look at the final 11 in the group of document names of the 27 listed on the topic of compounding.
| Summary | Document | Issue Date | FDA Organization | Topic | Guidance Status | Open for Comment | Comment Closing Date on Draft |
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| Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities: Guidance for Industry Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Guidance for Industry | PDF (645.92 KB) | 1/13/2017 | Center for Drug Evaluation and Research | Compliance, Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP) | Final | No | FDA-2014-D-1524 |
| Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff | PDF (555.16 KB) | 1/11/2017 | Office of Regulatory Affairs
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Drug Evalua-tion and Research | Investigation & Enforcement, Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP) | Final | No | FDA-2015-D-0198 |
| Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (190.66 KB) | 1/3/2017 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | FDA-2013-N-1428 |
| Prescription Requirement Under Section 503A of the Federal Food, Drug, an Cosmetic Act Guidance for Industry | PDF (348.92 KB) | 12/29/2016 | Center for Drug Evaluation and Research | Compounding | Final | No | FDA-2016-D-0269 |
| Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry | PDF (133.73 KB) | 6/10/2016 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding, Device & Drug Safety | Final | No | FDA-2015-D-3517 |
| Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (111.64 KB) | 6/10/2016 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | FDA-2015-D-3539 |
| Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (138.48 KB) | 19/08/2015 | Center for Drug Evaluation and Research | Compounding, Safety – Issues, Errors, and Problems | Final | No | FDA-2014-D-2138 |
| Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (74.03 KB) | 8/11/2015 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | |
| Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (71.02 KB) | 11/24/2014 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | FDA-2013-N-1429 |
| Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance | PDF (84.64 KB) | 7/2/2014 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | FDA-2013-D-1444 |
| CPG Sec. 460.200 Pharmacy Compounding (Withdrawn December 4, 2013) | | 12/3/2013 | | Investigation & Enforcement | Final | No | |
This completes the list of 27 entries on the topic of compounding (filtered from 2,690 total entries).
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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