Friday, February 26, 2021


12 hours ago — ... was a compounding pharmacy, which combined drugs with other substances ... drugs alleged to be "adulterated" because they had been compounded under .

Ex-employees of pharmacy in 2012 meningitis outbreak lose appeals 2/26/21 REUTERS LEGAL 21:44:35•Copyright (c) 2021 Thomson Reuters•Nate Raymond REUTERS LEGAL•February 26, 2021


6 hours ago — Jurors convicted Leary of charges including mail fraud related to three shipments of compounded drugs to hospitals that were misled about the quality of NECC's 


17 hours ago — All those conditions are treated with drugs manufactured by compounding ... to ask prescribers about compounded drugs, but his take-away is inescapable.


1 day ago — Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. A drug may be ...


9 hours ago — On Feb. 25, NCPA, in conjunction with other interested stakeholders in the compounding pharmacy space, filed an amicus curiae brief in the Wellness Pharmacy .


20 hours ago — The US Food and Drug Administration has updated information on compounding drugs during the COVID-19 pandemic, focusing on some specific compounded ...

The FDA has announced that it is working on guidance for states and for compounders on compounding drugs during the COVID-19 pandemic to protect....


FDA Preparing Guidance on Compounding Drugs During ...

8 hours ago — The FDA has announced that it is working on guidance for states and for compounders on compounding drugs during the COVID-19 pandemic to protect ..

Are some in the compounding pharmacy now advocating for federal standardized laws, rules and regulations that apply across all states rather than each state having their own patchwork set up laws, rules and regulations that are constantly changing? Why or why not? Should we now have the Uniform Compounding Pharmacy Code similar to other areas of law such as the Uniform Commercial Code? Why or why not?

Has the argument changed from pre-NECC days of the rules and regulations are fine--they just need to be followed and enforced to now an argument of they are constantly changing.  Is it that the compounding industry doesn't like it when the rules and regulations are actually enforced? Isn't it ironic how many have been charged with fraud and violating the rules and regulations that were in place--in place when this industry argued the rules just needed to be enforced. Rarely do those in the industry address or explain what they have done to correct that problem which was more than just a few bad apples--as many in the industry suggested at the time. Perhaps one could argue it is hard to argue for a position of an industry when the position of the industry keeps changing.  What exactly does the industry want to happen at this point?

Wednesday, February 24, 2021

Notice From Oklahoma State Board of Pharmacy Regarding Fraudulent Agent Scam


Oklahoma State Board of Pharmacy 

Fraudulent Agent Scam

Oklahoma City, February 24, 2021
Please be mindful, as a current scam involving the Oklahoma State Board of Pharmacy (OSBP) and other regulatory agencies including DEA, which involves “fake” agents contacting you in regards to an investigation. They're threatening suspension of licensing, etc. unless fines are paid to them. They are using letter head forms that seem to represent OSBP and other regulatory agencies including correct phone number, fax number, and email address. This is not, nor has ever been the manner in which the OSBP conducts investigations. If you are contacted please reach out to your Compliance Officer and/or the OSBP's main Office to verify.  

Tuesday, February 23, 2021

Must Read: Kill Shot


1 day ago — In his terrific but unnerving new book, “Kill Shot,” Associated Press investigative reporter Jason Dearen explores the shadow industry of compounding ...


4 days ago — The FDA's Center for Drug Evaluation and Research (CDER) released a list of the ... the agency's drug center's new guidance priorities are for the coming year. ... in 2020: animal rule, biosimilars, compounding and pharmacology/toxicology.


CDER 2021 Guidance Agenda - FDA

Jan 25, 2021 — 1 Final guidance documents planned for publication in calendar year 2021 are not included on this list. CDER is not ... Compounded Drug Products That Are Essentially Copies of a Commercially Available ... Tropical Priority Review Vouchers.


18 hours ago — We have many important and exciting priorities for 2021. ... This is compounded by many of the merger factors listed in s50(3), which can be ...

Review: New book spotlights rogue lab and a shadow industry of compounding pharmacies


1 day ago — And those drugs can blind or kill you, due in large part to an almost total absence of ... The story centers on the New England Compounding Center, which in 2012 ... Relying on transcripts, interviews, FDA inspection reports and other sources, ...


7 days ago — Pursuant to Local Civil Rule 7(o), the Alliance for Pharmacy Compounding, ... on behalf of millions of patients who benefit from compounded medications. APC's ... FDA published a Final Memorandum of Understanding (“MOU”) on October 27,.


13 hours ago — The Office of Pharmaceutical Quality (OPQ) within FDA's Center for Drug ... office is also tasked with overseeing the quality of OTC drugs and compounded drugs.

Former Sales Representative Indicted in Compounded Prescription Drug Scheme

 Department of Justice

U.S. Attorney’s Office
District of New Jersey

Tuesday, February 23, 2021

Former Sales Representative Indicted in Compounded Prescription Drug Scheme

NEWARK, N.J. – A former sales representative was arrested today for his role in a scheme to defraud public health benefits programs by billing for medically unnecessary compounded prescriptions, Acting U.S. Attorney Rachael A. Honig announced. 

Matthew Puccio, 38, of Randolph, New Jersey, was indicted by a federal grand jury on Feb. 17, 2021, for conspiracy to commit health care fraud. He will be arraigned at a date to be determined. 

According to the indictment returned yesterday:  

Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient is allergic to a dye or other ingredients in the prescription.

Between November 2014 and March 2016, Puccio participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public health benefits programs. The scheme centered on marketing companies recruiting and paying sales representatives, such as Puccio, to obtain compounded medications for themselves and others regardless of medical necessity, and by specifically targeting health plans that reimbursed for compounded medications at high rates.

Puccio exploited this opportunity through working as a sales representative for several compounding pharmacies. He targeted individuals who had health plans that covered compounded medications and then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity. Puccio and others induced two New Jersey based physicians to sign medically unnecessary prescriptions for beneficiaries that he and others had recruited.

Once the prescriptions were written, they were filled by the compounding pharmacies with which Puccio worked. The compounding pharmacies would then receive reimbursement from the health plans and would pay Puccio a percentage of the reimbursement amount.  

The charge of conspiracy to commit health care fraud carries a maximum sentence of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense.

Acting U.S. Attorney Honig credited special agents of the FBI, under the direction of Acting Special Agent in Charge George M. Crouch Jr. in Newark, with the investigation leading to today’s indictment.

The government is represented by Assistant U.S. Attorneys Emma Spiro and Sean M. Sherman of the U.S. Attorney’s Office’s Opioid Abuse Prevention and Enforcement Unit in Newark.

The charge and allegations contained in the indictment are merely accusations, and the defendant is presumed innocent unless and until proven guilty.

Health Care Fraud
Press Release Number: 
Updated February 23, 2021