Doesn't the ruling that the percentage of compounded drugs sold interstate was arbitrary force the FDA to then use the amount selected by Congress which is 5% or more? Why or why not? More importantly doesn't it just fortify the argument that the federal government/FDA should regulate any compounded drugs sold in interstate commerce? Why or why not?

 

Healthcare Law Update: October 2021 | Insights - Holland ...

https://www.hklaw.com › publications › 2021/10 › heal...

2 days ago — Most significantly, compounding pharmacies operating within the bounds of Section ... However, a health system pharmacy that compounds drug products without .

 

FDA Revises Health System Compounding Guidance ...

https://www.lexology.com › library › detail

6 days ago — Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section ...

 Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans

An Orange County pharmacist has been sentenced to 70 months in federal prison for submitting more than $13 million in claims for medically unnecessary compounded medication prescriptions, the Justice Department announced today.

 

Attachment inserts for meeting materials - California State ...

https://www.pharmacy.ca.gov › 21_oct_enf_mat

PDF

4 days ago — Approval of July 15, 2021, Enforcement and Compounding Committee Meeting ... reporting requirements for pharmacies distributing compounded human drug ...

 

Indian hospital pharmacies underscore US FDA norms on ...

http://www.pharmabiz.com › NewsDetails

16 hours ago — Indian hospital pharmacies underscore US FDA norms on drug compounding at medical ... Some of these compounders seek to compound drugs under section 503A.

 

Calabasas Doctor Sentenced to 14 Months in Federal Prison ...

https://www.justice.gov › ... › News

5 days ago — Calabasas Doctor Sentenced to 14 Months in Federal Prison for Accepting Bribes as Part of Compounded Medication Conspiracy.

 

Dallas Pharmacist Pleads Guilty to Adulterating Compounded ...

https://www.dmagazine.com › 2021/10 › dallas-pharma...

5 days ago — Compounding drugs is often at the center of these fraud cases. It is the practice of combining, mixing, or altering medicine ingredients to create a new ..

 

Doctor sentenced in compounding scheme | Business Insurance

http://www.businessinsurance.com › article › NEWS08

1 day ago — Doctor sentenced in compounding scheme. A southern California doctor was sentenced to 14 months in prison for accepting nearly $800,000 in bribes and ...

 

10/19/2021	10/19/2021	HotHead Vapor	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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10/19/2021	10/08/2021	AriBio H&B Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
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