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		FDA Good Guidance Practices, Part 5

This week, we will look at titles of current Guidance Documents available for downloading that are applicable to 503a or 503b compounding pharmacies.

Search for FDA Guidance Documents | FDA

From the website:

The FDA Guidance Documents and other regulatory guidance can be downloaded from FDA's website. Below is an example of the first 8 listings when you search FDA's website for FDA Guidance Documents/compounding.

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.

Summary	Document	Issue Date	FDA Organization	Topic	Guidance Status	Open for Comment	Comment Closing Date on Draft	Docket Number
CVM GFI #256-Compounding Animal Drugs from Bulk Drug Substances	PDF (404.91) KB)	8/10/2022	Center for Veterinary Medicine	Compounding	Final	No	10/15/2020	FDA-2018-D-4533
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry	PDF (122.11 KB)	10/6/2021	Center for Drug Evaluation and Research	Compounding	Draft	No		FDA-2016-D-0271
Insanitary Conditions at Compounding Facilities Guidance for Industry	PDF (123.19 KB)	11/6/2020	Center for Drug Evaluation and Research	Administrative / Procedural, Compounding	Final	No		FDA-2016-D-2268
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry	PDF (76.64 KB)	4/20/2020	Center for Drug Evaluation and Research	Compliance, Compounding	Final	No		FDA-2020-D-1136
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency	PDF (208.46 KB)	4/16/2020	Center for Drug Evaluation and Research	Compounding	Final	No		FDA-2020-D-1136
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act	PDF (172.27 KB)	4/3/2020	Center for Drug Evaluation and Research	User Fees, Compounding	Final	No		FDA-2014-D-0329
Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry	PDF (484.69 KB)	1/22/2020	Center for Drug Evaluation and Research	Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)	Draft	No	2/11/2019	FDA-2014-D-0779
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients with Te-trahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry	PDF (77.61 KB)	7/8/2019	Center for Drug Evaluation and Research	Compounding	Final	No		FDA-2019-D-2733

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

Did You Know (On Government)...

...the following?

"We must warn ourselves over and over, that we cannot have something for nothing. The wages of state welfare is tyranny of the state." (Anon)

"The greater the power, the more dangerous the abuse." (Edmund Burke)

Thought of the Week (On Government)

"Bureau: In the old days a bureau was a place you hide your money so you could save it. Today, a government bureau is a place where they take your money so they can spend it." (Anon)

"A government expert is one who complicates simple things!" (Anon)

"What is the best government? One that teaches us to govern ourselves." (Goethe)

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

From Out of the Past

A big improvement
Since the war
Is now on sale
In your drug store!
Burma-Shave


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