Tuesday, November 16, 2021

 

Non-Resident Pharmacy Compounding in Ohio

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.

Wednesday, November 10, 2021

 

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

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

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 

Oklahoma Supreme Court Throws Out $465 Million Opioid Ruling Against J.&J. The 5-1 decision is a setback for those who are fighting to hold big drug makers accountable for the opioid epidemic.

https://www.nytimes.com/2021/11/09/health/oklahoma-supreme-court-johnson-johnson-opioids.html 

If you take this pain medicine, there’s an FDA recall so stop and call your doctor Chris Smith 8 hrs ago

 https://www.msn.com/en-us/health/medical/if-you-take-this-pain-medicine-there-s-an-fda-recall-so-stop-and-call-your-doctor/ar-AAQxKUX?ocid=msedgntp

Tuesday, November 9, 2021

 

Why Regulatory, Compliance Lawyers Should Watch This ...

9 hours ago — The defendant, Professional Compounding Centers of America Inc., ... the amount to reimburse pharmacies for the compound prescription claims they submit.

 

Texas Pharma Company Inflated Prices Over 400 Times ...

13 hours ago — 8, the DOJ filed the complaint under the False Claims Act against Professional Compounding Centers of America Inc. (PCCA), for blowing up Average Wholesale ...