Sunday, January 31, 2021

Note: Warning in comments regarding the amount of api used for compounded drugs that ends up in water supply/going down drain. Is this true?


3 days ago — FDA issued warning letters to 9 firms who manufacture and sell unauthorized ... FDA warned Professional Compounding Centers of America Inc. for putting 


2 days ago — The warning letter also took issue with Edge Pharma's characterization of itself ... (CDER) warned a compounding center for multiple and significant violations,


3 days ago — FDA issued warning letters jointly with @FTC to Allimax, and to AusarHerbs, for ... FDA issues warning letter to Professional Compounding Centers of America ..


Jan 22, 2021 — Alliance for Pharmacy Compounding News. ... Alliance of State Pharmacy Associations, National Community Pharmacists Association, OSRX, 

The US Food and Drug Administration issued a warning letter to Professional Compounding Centers of America (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). 

FDA Urges Compounding Firms to 'Know Their API Supplier .


3 days ago — PCCA, a compounding pharmacy consulting firm and provider of drug ingredients and compounding devices, was warned by the FDA in a follow up to an Oct. 22-29, 2019 inspection.


4 days ago — ... Prison for Role in $24 Million Telemedicine Compounded Medication Scheme ... scheme to prescribe expensive compounded medications to patients who did ...


4 days ago — Bernard Ogon signed prescriptions for costly compounded medications, ... has received a 33-month prison term for taking part in a prescription drug scam, 


4 days ago — Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised .

Pharmaceutical Supply Chain Infiltrated with Methanol


4 days ago — The Excerpt below from page 9 of the guidance addresses compounding: “Compounded drug products containing ethanol with more than 200 ppm methanol may .


3 days ago — Compounded medications are custom-made drugs specifically mixed and prepared to meet the needs of a particular patient. According to court documents and ..


3 days ago — National Academies of Science, Engineering, and Medicine (NASEM) Partnership. FDA has engaged NASEM to conduct two studies related to compounded drug ...


4 days ago — The California State Board of Pharmacy has compiled a list of compounded preparations that may be available from California licensed outsourcing facilities.


9 hours ago — Alliance for Pharmacy Compounding raised $121120 in the 2019-2020 election cycle. See the details.

 Department of Justice

U.S. Attorney’s Office
Middle District of Florida

Wednesday, January 27, 2021

United States Files False Claims Act Complaint Alleging Compounding Pharmacy Kickback Scheme

United States Attorney Maria Chapa Lopez announces that the government has filed a civil lawsuit against Mihir Taneja alleging that Taneja conspired with Larry Smith, the owner of Z Stat Medical, LLC d/b/a Oldsmar Pharmacy, to enter into a kickback arrangement with a marketing company (Centurion Compounding, Inc.), which led to millions of dollars in TRICARE reimbursement for compounding prescriptions. Specifically, the lawsuit alleges that Taneja and Smith negotiated an arrangement with Centurion in which Centurion was paid a percentage of profits from TRICARE claims that Centurion referred to Oldsmar Pharmacy. As a result, from November 2014 to February 2015, Oldsmar Pharmacy submitted thousands of claims for reimbursement to TRICARE for compounded drugs that were tainted by kickbacks and, therefore, were false. 

The actions of Taneja and his co-conspirators contributed to a larger fraud trend against TRICARE involving compounded prescriptions. TRICARE’s costs for compounded drugs skyrocketed during this period, rising from $5 million in 2004 to $514 million in 2014, before reaching a high water mark of $1.75 billion in fiscal year 2015. To date, the U.S. Attorney’s Office for the Middle District of Florida has diligently pursued fraud associated with compounding pharmacy claims, resulting in over $50 million in recoveries. 

“Kickback arrangements skew the judgment of medical providers and threaten the integrity and viability of our healthcare programs,” said U.S. Attorney Chapa Lopez. “The TRICARE program has been particularly vulnerable to these schemes in recent years. We will use every remedy at our disposal, including the civil False Claims Act, to eradicate this kind of fraud from our district.”

The lawsuit is filed under the False Claims Act, which makes a person liable to the United States if he presents, or causes another to present, false or fraudulent claims for payments. The Anti-Kickback Statute prohibits anyone from offering or paying remuneration in order to induce or reward referrals for services paid for under federal healthcare systems.

The case is captioned United States v. Mihir Taneja, Case No. 8:21-cv-102-T-24AEP. The claims asserted by the government are allegations only, and there has been no determination of liability. The United States previously filed suit against Smith and Oldsmar Pharmacy arising out of the same conduct. That case is captioned U.S. ex rel. Silva, et al. v. Z Stat Medical, LLC, et al., No. 8:15-cv-00444-T-33TGW (M.D. Fla.). 

The government’s complaint in this action illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).

The case is being handled by Assistant U.S. Attorney Michael R. Kenneth of the U.S. Attorney’s Office for the Middle District of Florida, with assistance of the Department of Defense Office of Inspector General. 

False Claims Act

WARNING LETTER Professional Compounding Centers of America dba PCCA MARCS-CMS 597638 — JANUARY 27, 2021 

Tuesday, January 26, 2021


6 hours ago — The Wisconsin hospital pharmacist who was fired for intentionally destroying hundreds of Covid-19 vaccine doses has agreed to plead guilty to federal charges.


5 days ago — Cedar Grove man admits role in $5.3M compounded prescription drug scheme. | 08-03. NEWARK, NJ — On July 29, an employee of a .


5 days ago — Two private equity firms bought SCA Pharmaceuticals, a compounding pharmacy with major operations in Windsor, the company announced Friday. The Vistria .


Pharmacy Commission Meeting Agenda - January 22, 2021

5 days ago — amounts of distributions of compounded human drug products interstate and ... (Safe Donation and Reuse of Unexpired Prescription Drugs). 5.6 2021 ...


1 day ago — Compound drugs are made by a pharmacist mixing multiple ingredients to create a prescription drug that's specific to a beneficiary's needs. TRICARE screens ...