Friday, January 26, 2024


North Texas pharmacy kickback case ends in convictions

Jan 17, 2024 — Compounding pharmacies fell under intense federal scrutiny beginning around 2014 due to allegations of massive fraud. North Texas pharmacies were among those .


FDA Releases Draft Interim Guidance on Bulk Drug ...

Jan 10, 2024 — The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under ...


Section 535:15-10-8 - Drug compounding controls, Okla. ...

Jan 2, 2024 — Okla. Admin. Code § 535:15-10-8 · (1) Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available .


Billing Code: 4510-CH-P

17 hours ago — See Compounding Quality Act, Public Law 113-. 54, 127 Stat. 587 (2013). Compounded medications (which may contain opioids) have two or more ingredients and


1/8/24 - Ohio Board of Pharmacy

Jan 8, 2024 — Since 2015, the Board has required compliance with national compounding standards, USP 795 (for non-sterile drug compounding) and USP 797 (for sterile drug ...


Memphis Orthopedic Clinic Agrees to Pay ...

2 days ago — Memphis Orthopedic Clinic Agrees to Pay $540,000 to Settle False Claim Allegations Related to Compound Drug Injections. Wednesday, January 24, 2024 | 10:29am.


Policy and Procedures for Coverage of Drugs

Jan 9, 2024 — The compounded drug must meet all the criteria for coverage set forth in the WTC Health Program Pharmacy Formulary.21 Only FDA- approved ingredients in the ...


Two New Jersey Men Sentenced to Prison for Roles in Multimillion-Dollar Compounded Prescription Drug Scheme

For Immediate Release
U.S. Attorney's Office, District of New Jersey

NEWARK, N.J. – Two New Jersey brothers have been sentenced to prison for their roles in a scheme to defraud public and private health benefits programs, U.S. Attorney Philip R. Sellinger announced today.

John Cuffari, 61, of Cedar Grove, New Jersey, was sentenced to 17 months in prison for his role in defrauding benefits programs of at least $5.3 million for the billing of medically unnecessary compounded prescriptions. He previously pleaded guilty to an information charging him with conspiracy to commit health care fraud. U.S. District Judge Renee Bumb imposed the sentence on Jan. 4, 2023, in Camden federal court.

Christopher Cuffari, 57, of Little Falls, New Jersey, was sentenced to 27 months in prison for his role in defrauding benefits programs of $7.89 million for the billing of medically unnecessary compounded prescriptions. He previously pleaded guilty to an information charging him with conspiracy to commit health care fraud. U.S. District Judge Peter Sheridan imposed the sentence on Jan. 3, 2024, in Trenton federal court.

“By their own admission, these defendants bilked publicly and privately funded insurance plans of millions of dollars in fraudulent reimbursements for compounded medications. Working with our partners, we will prosecute those who take advantage of our health care system to generate illicit income.”

U.S. Attorney Philip R. Sellinger

“This investigation is only one example of how the belief that these cases have no victims is not true,” FBI – Newark Special Agent in Charge James E. Dennehy said. “Fraud creates tougher regulations and policies from government agencies and insurance companies to prevent it from taking place. That trickles down to patients who have a much harder time getting the healthcare they may desperately need. The Cuffari brothers are just a small cog in a tremendously frustrating wheel of criminals, but we won't be deterred from bringing every one of them to justice.”

According to documents filed in this case and statements made in court:

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 July 2016, John Cuffari participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public and private insurance plans. Christopher Cuffari participated in the conspiracy between November 2014 and September 2017. The scheme centered on the discovery that certain insurance plans paid for prescription compounded medications – including scar creams, wound creams, and metabolic supplements/vitamins – at exorbitant reimbursement rates.

John and Christopher Cuffari worked as sales representatives for several marketing companies and compounding pharmacies and targeted individuals who had insurance plans that covered compounded medications. They then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity, often by providing them with cash payments. In order to obtain prescriptions for compounded medications for some of the recruited individuals, the defendants caused payments to be made to a New Jersey-based physician.

In addition to the prison terms, both defendants were sentenced to three years of supervised release.

U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge James E. Dennehy in Newark, with the investigation leading to the sentencings.

The government is represented by Assistant U.S. Attorney Chelsea D. Coleman of the U.S. Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.

Updated January 5, 2024

Press Release Number: 24-005


USP revised compounding standards go into effect

Jan 4, 2024 — Revised compounding standards from the United States Pharmacopeia (USP) became effective November 1, 2023, after 12 years of work. According to the USP, ...

Thursday, January 25, 2024

FDA Issues Warning About Supplement Containing Potentially Deadly Antidepressant Story by Taiyler S. Mitchell • 19h


he Federal Drug Administration has issued a warning against the use of over-the-counter supplements that contain an antidepressant called tianeptine, due to serious risks including seizures, loss of consciousness and death.

Neptune‘s Fix brand products have been sold at gas stations, smoke shops and convenience stores and illegally online, according to a statement from the agency. They reportedly contain tianeptine, nicknamed “gas station heroin” and marketed under the names Coaxil, Stablon and Tatinol. The drug is not approved for medical use in the U.S. and has been banned at least 9 states.

FDA Issues Warning About Supplement Containing Potentially Deadly Antidepressant (


FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2022 for Use in Food-Producing Animals

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine published the 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This year’s data show that domestic sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals increased by four percent between 2021 and 2022; compared to 2015 (peak year of sales), 2022 sales were down 36 percent. Sales volume may fluctuate over time in response to various factors, including changing animal health needs or changes in animal populations.

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FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act

Ensuring reliable patient access to safe and effective medicines requires every link in the supply chain to be secure: from the moment a drug leaves the manufacturer until it reaches a pharmacy or health care professional’s offices. Since 2013, the U.S. Food and Drug Administration has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful.

Requirements of this law improve supply chain security activities by trading partners, for example, prescription drug manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers, primarily pharmacies. Gradual implementation of the requirements for product tracing, product identification, authorized trading partners, and verification, is helping trading partners develop required systems for interoperable, electronic tracing of products down to the package level. Interoperable electronic systems are those that can exchange data accurately, efficiently, and consistently about each package (i.e., smallest individual saleable unit) as it is distributed in the U.S.

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 On Monday, the FDA announced the launch of its Cosmetics Direct electronic submission portal for registration of cosmetic product facilities and listing of cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The FDA also issued a final guidance for industry on registration and listing of cosmetic product facilities and products. The final guidance also includes a new draft section, for public comment, that describes frequently asked questions and answers. The final guidance and new electronic submission portal are part of our continuing efforts to advance the implementation of MoCRA. With MoCRA’s new registration and listing requirements, the FDA will have a more complete picture of the cosmetic products distributed in the U.S.

 FDA has received reports of consumers who have used fat-dissolving injections that are not FDA approved and that have caused adverse reactions, including permanent scars, serious infections, skin deformities, cysts, and deep, painful knots. Some consumers received the injections at clinics or med spas by personnel who might not have been properly licensed to give the injections. In addition, some consumers who reported adverse reactions purchased the unapproved fat-dissolving drugs online and injected the drugs themselves.

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