• SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

 

11/16/2021

11/10/2021

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine

Division of Pharmaceutical Quality Operations Division III

Compounding Pharmacy/Adulterated Drug Products

 

11/16/2021

11/10/2021

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine

Division of Pharmaceutical Quality Operations Division III

Compounding Pharmacy/Adulterated Drug Products

 

Investigations Newsletter: DOJ Files Complaint in AWP False ...

https://www.jdsupra.com › legalnews › investigations-n...

11 hours ago — (PCCA), a Houston-based company that sells pharmaceutical ingredients and other products and services to compounding pharmacies. The government alleges that

 

Non-Resident Pharmacy Compounding in Ohio

https://www.pharmacy.ohio.gov › Pubs › Special

PDF

7 days ago — The compounding pharmacy's responsible person must be Ohio Licensed by 12/1/2021: A pharmacy licensed as a non-resident pharmacy that is engaged.

 

Bulk Drug Substances Used in Compounding | FDA

https://www.fda.gov › drugs › bulk-drug-substances-us...

7 days ago — Because compounding from these substances presents risks to patients, ... pharmacist or physician, or an outsourcing facility, might compound a drug product

Kaleo settles U.S. probe over pricy overdose treatment for $12.7 million By Nate Raymond

https://www.reuters.com/legal/government/kaleo-settles-us-probe-over-pricy-overdose-treatment-127-million-2021-11-09/ 

 

The last drugstore: Rural America is losing its pharmacies

https://www.washingtonpost.com › business › 2021/11/10

11 hours ago — More than 1000 independent pharmacies in rural America have closed since 2003, leaving 41 million people stuck without easy access to drug stores.

 

What Fraud on the FDA Really Looks Like - Drug & Device Law

https://www.druganddevicelawblog.com › 2021/11 › w...

12 hours ago — Pharmacy compounding has a long history and is an entirely legitimate practice. Ordinarily the states regulate the practice of pharmacy, but since compounding 

U.S. v. Carter, 15 F.4th 26 (1st Cir. 2021), where the government successfully prosecuted a claim for fraud on the FDA, involving the concealment of unlicensed pharmaceutical manufacturing in guise of “pharmacy compounding.

https://cases.justia.com/federal/appellate-courts/ca1/19-1644/19-1644-2021-09-27.pdf?ts=1632776405