USP Publishes Notice of Intent to Revise New Compounding ...

https://www.quarles.com › publications › usp-publishes-notice-of-intent-to...

6 hours ago - On September 23, 2019, the United States Pharmacopeial Convention (USP) published a Notice of Intent to Revise its new compounding standards, initially 

USP delays release of updated compounding standards

https://www.beckershospitalreview.com › pharmacy › usp-delays-release-o...

3 hours ago - The United States Pharmacopeia is postponing the release of several revised compounding standards because of appeals against them, according to a Sept. 23 American Hospital Association news release. Th

ATTORNEY'S OFFICE OF FLORIDA: Compounding Pharmacy, Two of Its Executives, and Private Equity Firm Agree to Pay $21.36 Million to Resolve False Claims Act Allegations

ATTORNEY'S OFFICE OF FLORIDA: Compounding Pharmacy, Two of Its Executives, and Private Equity Firm Agree to Pay $21.36 Million to Resolve False Claims Act Allegations: The Department of Justice announced that compounding pharmacy Diabetic Care Rx LLC, or Patient Care America (PCA), PCA’s Chief Executive Officer Patrick Smith, PCA’s former Vice President of Operations Matthew Smith, and private equity firm Riordan, Lewis & Haden Inc. (RLH) have agreed to resolve.

09/17/2019

06/11/2019

Deb USA Inc.

Division of Pharmaceutical Quality Operations II

CGMP/Finished Pharmaceuticals/Adulterated

09/24/2019

09/12/2019

Nutra Solutions USA, Inc.

Division of Human and Animal Food Operations East I

CGMP/Dietary Supplement/Adulterated/Misbranded

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation

Today, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA’s ongoing investigation related to JUUL. “Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or...

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FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer). “The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand the issue and provide our best recommendation to the public as quickly and accurately as possible,” said Acting FDA Commissioner Ned Sharpless, M.D. “We will continue to investigate and work to...

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2 Long Island Pharmacy Workers Charged In $99M Kickback Scheme They were charged in a massive kickback and fraud scheme. By Daniel Hampton, Patch Staff

https://patch.com/new-york/glencove/2-long-islander-pharmacy-workers-charged-99m-kickback-scheme

Judge rules against Liberty Mutual in pharmacy-fraud lawsuit The insurer argued that doctor-owned pharmacies were receiving unlawful prescription kickbacks for workers' comp patients. By Max Mitchell | September 19, 2019 at 10:30 AM

https://www.propertycasualty360.com/2019/09/19/phila-judge-throws-out-insurance-fraud-suit-against-doctor-owned-pharmacies-over-alleged-kickbacks-414-163530/?slreturn=20190820014400

16 doctors and medical professionals charged in fraud and opioid takedown in Texas by Joanne Finnegan | Sep 18, 2019 3:39pm

https://www.fiercehealthcare.com/practices/16-doctors-and-medical-professionals-charged-fraud-and-opioid-takedown-texas