First Circuit's New England Compounding Center Decisions Illustrate Reach of Federal Criminal Law

https://www.jdsupra.com/legalnews/first-circuit-s-new-england-compounding-55733/

The Clock is Ticking: The Countdown to Final Compounding Pharmacy Prosecutions

https://www.jdsupra.com/legalnews/the-clock-is-ticking-the-countdown-to-59733/

FDA adds drug to compounding lists; recalls hand sanitizers ...

www.aha.org › news › headline › 2020-07-15-fda-adds...

3 days ago - The Food and Drug Administration added dexamethasone sodium phosphate to its lists for temporary compounding by outsourcing facilities and pharmacy ..

FD&C Act Provisions that Apply to Human Drug Compounding ...

www.fda.gov › drugs › fdc-act-provisions-apply-huma...

5 days ago - Section 503A of the FD&C Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed .

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Compounding Activities | COVID-19 | FDA

www.fda.gov › drugs › coronavirus-covid-19-drugs

5 days ago - The agency's guidance aims to protect patients from unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients. Outsourcing ..

07/14/2020	07/13/2020	Kegan Wellness	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/13/2020	07/10/2020	Health Beauty Love	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/08/2020	07/07/2020	Ionogen, LLC	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections

Merck CEO Frazier says COVID-19 vaccine hype a 'grave disservice' to the public

Warp Speed initiative aims for COVID-19 vaccine production within 6 weeks: Reuters

FDA Issues Revised Draft Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration has released updated information to help researchers and animal drug sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS). The FDA’s mission is to protect and promote the health of both human and animals, including those animals that are considered “minor species” – animals other than those typically thought of as livestock (cattle, pigs, chickens, turkeys) or companions (dogs, cats, horses). Minor species are animals that may not be quite so common – such as sheep, goats, and ferrets, but also zoo animals, wildlife, and insects like honey bees. Similarly, the FDA has a responsibility to facilitate approval of treatments for conditions that are relatively rare in the major species, or which occur in small numbers or in limited geographic areas. Some examples of minor uses in major species include various cancers in dogs or regional occurrences of diseases, such as outbreaks of blackhead in turkey flocks in the Southern U.S. Because MUMS drugs, by definition, are for use in relatively small markets, there is less economic incentive for a drug company to invest in the research and development necessary to bring a product to market via the traditional new animal drug approval process.

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