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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 next 8 in the group of document names of the 27 listed.
| Summary | Document | Issue Date | FDA Organization | Topic | Guidance Status | Open for Comment | Comment Closing Date on Draft |
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| Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Guidance for Industry | PDF (68.34 KB) | 5/24/2019 | Center for Drug Evaluation and Research | Administrative / Procedural, Compounding | Final | No | |
| Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food and Drug, and Cosmetic Act | PDF (323.4 KB) | 3/13/2019 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry | PDF (324.37 KB) | 9/26/2018 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry | PDF (306.64 KB) | 9/26/2018 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act | PDF (86.66 KB) | 5/10/2018 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal, Food, Drug, and Cosmetic Act Guidance for Industry | PDF (552.95 KB) | 1/19/2018 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry | PDF (468.33 KB) | 1/19/2018 | Center for Drug Evaluation and Research | Compounding | Final | No | |
| Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry | PDF (555.69 KB) | 1/18/2018 | Center for Drug Evaluation and Research | Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP) | Final | No | 3/13/2017 |
Continued next week.
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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Did You Know (On Government)...
"Every wanton and causeless restraint of the will of a subject, whether practiced by a monarch, a nobility, or a popular assembly, is a degree of tyranny." (William Blackstone) |
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Thoughts for the Week (On Government)
"The four pillars of government... religion, justice, counsel and treasure." (Francis Bacon)
"A man must first govern himself ere he is to govern a family; and his family ere he be fit to bear the government of the commonwealth." (Sir Walter Raleigh)
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