Friday, March 31, 2023

This week, the FDA approved three first-time generic animal drugs, bringing additional options to the table for veterinarians, pet owners and animal producers: On Wednesday, the FDA approved Modulis for Cats, the first generic cyclosporine oral solution for cats. Modulis for Cats is indicated for the control of certain skin conditions resulting from a disease called feline allergic dermatitis. On Thursday, the FDA approved Tauramox, the first generic moxidectin injectable solution indicated for beef and nonlactating dairy cattle for the treatment and control of internal and external parasites in cattle. Today, the FDA approved the first generic Maropitant Citrate tablets for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.

Wednesday, March 29, 2023

Westlab Pharmacy, Inc., (dba Westlab Pharmacy), Gainesville, FL - 503A Facility

  • FMD-145 Letter Issued 1/10/2023

 QuVa Pharma Inc. Temple, TX - 503B Facility

  • FMD-145 Issued 01/3/2023

 Gipsco Investment Corp. (dba Lee Silsby Compounding Pharmacy), Cleveland Heights, OH - 503A Facility

  • FMD-145 Issued 1/6/2023

 First Royal Care Co. LLC, (dba Red Mountain Compounding Pharmacy), Mesa, AZ - 503A Facility

  • FMD-145 Letter Issued 2/13/2023

 Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility

  • FMD-145 Letter Issued 1/18/2023

 Bhaumik Diversified LLC dba Texas Star Pharmacy, Dallas, TX - 503A Facility

  • FMD-145 Letter Issued 1/17/2023


Swedesboro woman admits role in prescription-drug scam

Mar 2, 2023 — Compounded-medication scam ... Lyons-Valenti authorized unneeded prescriptions for the costly drugs, known as compounded medications, while working as an

Opioids and improving the quality of compounded drugs are on the FDA's 2022 drug safety priorities report


Opioids top FDA's 2022 drug safety priorities report

Mar 2, 2023 — The head of the US Food and Drug Administration's (FDA) drug center said the ... shortage of critical drugs, and improving the quality of compounded drugs, ...


Former Pharmaceutical Sales Representative Admits Role In Health Care And Wire Fraud Conspiracy

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

CAMDEN, N.J. – A former pharmaceutical sales representative today admitted defrauding New Jersey state and local health benefits programs and other insurers by submitting fraudulent claims for medically unnecessary prescriptions, Attorney for the United States Vikas Khanna announced.

Vincent Tornari, 49, of Linwood, New Jersey, pled guilty today via videoconference before Judge Robert B. Kugler to one count of an indictment charging him with conspiring to commit health care fraud and wire fraud. Tornari was previously charged with Dr. Brian Sokalsky, 44, of Margate, New Jersey, and former advanced nurse practitioner Ashley Lyons-Valenti, 66, of Swedesboro, New Jersey, in June 2020. Lyons pleaded guilty on Feb. 28, 2023, to health care fraud conspiracy. The conspiracy to which Tornari pleaded guilty also involved former pharmaceutical sales representative Mark Bruno, 48, of Northfield, New Jersey, who pleaded guilty on Dec.16, 2019, to health care fraud conspiracy and obstruction of justice. The charges against Sokalsky remain pending and he is scheduled to proceed to trial on April 24, 2023. The charges and allegations against Sokalsky are merely accusations, and he is presumed innocent unless and until proven guilty.

According to court documents 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 ingredient.

The conspirators learned that certain medications made by compounding pharmacies reimbursed for up to thousands of dollars for an individual’s one-month supply. They learned that certain insurance plans – including insurance plans for state and local government employees and certain other insurance plans – covered these medications.

Tornari’s company had an agreement with a compounding pharmacy in Pennsylvania to receive 50 percent of the insurance reimbursement for prescriptions that were arranged by him and those working with him, such as Bruno. Tornari then paid Bruno 20 percent of that amount.

Tornari and Bruno approached Sokalsky to secure his authorization for prescription medications made by the compounding pharmacy. Sokalsky agreed to prescribe the medications in exchange for cash and other remuneration. Sokalsky prescribed the medications to people Bruno paid cash to agree to receive the medications, even though those individuals did not need those medications and did not have a pre-existing doctor-patient relationship with Sokalsky.  Sokalsky then billed insurance plans for patient visits for the people Bruno directed to his medical practice.

Sokalsky also prescribed the medications to existing patients of his medical practice – as opposed to other medications or no medications at all – to financially benefit Tornari, Bruno, and himself.  When insurance stopped covering certain formulations of the medications, Tornari and Bruno informed Sokalsky that he needed to authorize new prescriptions. Sokalsky did so, often without seeing the individual for a follow-up visit or informing the person of the change in medication. The fraudulent prescriptions cost insurers over $541,000 and Tornari personally received more than $359,000 as part of the scheme.

Tornari faces a maximum penalty of 20 years in prison and a $250,000 fine. Sentencing is scheduled for July 25, 2023. 

Attorney for the United States Khanna credited agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge James E. Dennehy in Newark; special agents of IRS – Criminal Investigation, under the direction of Acting Special Agent in Charge Tammy Tomlins in Newark; and special agents of the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Jonathan Mellone, with the investigation leading to today’s guilty plea. 

The government is represented by Christina O. Hud, Senior Trial Counsel in the Health Care Fraud Unit; R. David Walk Jr., Deputy Chief of the Criminal Division; and Assistant U.S. Attorney Daniel A. Friedman.

Updated March 14, 2023

Former Director of Operations for O.C. Pharmacy Sentenced to 9½ Years in Prison for Defrauding the U.S. Military’s Health Care Plan for Role in Compounding Medication scheme


Former Director of Operations for O.C. Pharmacy Sentenced to 9½ Years in Prison for Defrauding the U.S. Military’s Health Care Plan

For Immediate Release
U.S. Attorney's Office, Central District of California

LOS ANGELES – A Florida man who once was the director of operations at a now-shuttered Irvine pharmacy was sentenced today to 114 months in federal prison for his role in a scheme in which kickbacks were paid for prescriptions for “compounded” medications – a scam that cost Tricare, the United States military’s health care plan, more than $3 million in losses.

Marcus Orlando Armstrong, 56, of Miami, was sentenced by United States District Judge Otis D. Wright II, who also ordered Armstrong to pay $3,070,091 in restitution.

Armstrong pleaded guilty in October 2022 to two counts of paying illegal kickbacks for health care referrals.

Armstrong was the director of operations for the now-defunct Irvine Wellness Pharmacy, which made compounded medications. Compounded drugs are tailor-made products doctors may prescribe when the Food and Drug Administration-approved alternative does not meet the health needs of a patient.

In mid-2014, Armstrong agreed to pay a physician, identified in court documents as “N.G.,” kickbacks in exchange for prescriptions bearing N.G.’s name and credentials. Armstrong intended that Irvine Wellness Pharmacy would fill the prescriptions and Tricare would pay to reimburse them. Armstrong further intended to receive a portion of the reimbursements and then, out of those funds, Armstrong intended to pay kickbacks to N.G.

In February 2015, Armstrong wrote two checks – one for $16,418 and the other for approximately $10,000 – to N.G. that were noted as being for “marketing.” In fact, the checks were illegal kickback payments to N.G. in exchange for prescriptions that were not medically necessary.

A co-defendant, Sandy Mai Trang Nguyen, 42, of Irvine, was found guilty by a jury in November 2022 of 21 counts of health care fraud and one count of obstruction of a federal audit. Nguyen was the pharmacist-in-charge at Irvine Wellness Pharmacy.

According to evidence presented at Nguyen’s trial, from late 2014 to May 2015, Nguyen and others under her supervision filled approximately 1,150 compounded prescriptions for pain, scarring and migraines that Tricare reimbursed for tens of thousands of dollars per prescription. Nearly all the prescriptions were sent to the pharmacy by so-called marketers who were paid kickbacks of nearly half of the Tricare reimbursements paid to the pharmacy.

The beneficiaries were solicited to provide their Tricare insurance information for medications they did not seek out or need, and most were never examined by a physician. The prescriptions were electronically sent from marketers or telemedicine businesses and submitted by the pharmacy for reimbursement even though Tricare rules excluded reimbursements for claims based on telemedicine visits and would not, in any event, have been authorized had Tricare known the prescriptions originated based upon the payment of kickbacks.

Nguyen’s sentencing hearing is scheduled for April 3.

Co-defendants Leslie Andre Ezidore, 53, of West Los Angeles, and Alexander Michael Semenik, 51, of Las Vegas, have pleaded guilty to felony charges in this case and await sentencing.

The Department of Defense Office of Inspector General; the Defense Criminal investigative Service; the FBI; the Amtrak Office of Inspector General; IRS Criminal Investigation; the United States Department of Labor – Employee Benefits Security Administration; the California Department of Insurance; and the Office of Personnel Management Office of Inspector General investigated this matter.

Assistant United States Attorneys Mark Aveis and Ali Moghaddas of the Major Frauds Section prosecuted this case.


Ciaran McEvoy
Public Information Officer
(213) 894-4465

Updated March 20, 2023


Compounded Ozempic and Wegovy

Mar 19, 2023 — Compounding pharmacies mix and alter drug ingredients to create medications tailored to specific patient needs, according to the Food and Drug Administration.


Iowa Administrative Code Supplement

8 days ago — Storage of bulk dry animal nutrients. 49.8(200A) ... Notification of chief of animal industry ... 20.12(126,155A) Compounding copies of an approved drug


SB0036 - Utah Legislature

Mar 11, 2023 — 598 of animals of a prescription drug for the purpose of injection, inhalation, ... 642 production, wholesale, or distribution of drugs or devices in Utah


Legislation | NY State Senate

Mar 10, 2023 — "Pharmacy" means any place in which drugs, prescriptions or poisons are possessed for the purpose of compounding, preserving, dispensing or retailing, 


Bill tracking in New Mexico - SB 92 (2023 legislative session)

Mar 14, 2023 — "Compounding" also includes preparing drugs or devices in anticipation of a prescription ... treatment or prevention of disease in humans or other animals;.


Webinar: How New FDA Guidance Will Impact Your Practice

Mar 2, 2023 — GFI #256, Compounding Animal Drugs from Bulk Drug Substances, establishes the parameters within which veterinarians may use compounded drugs prepared from ..


8 days ago — This means that although compounding from bulk substances for animal patients is still considered illegal, pharmacists and veterinarians may compound drugs ...
Mar 17, 2023 — This means that although compounding from bulk substances for animal patients is still considered illegal, pharmacists and veterinarians may compound drugs ...
Mar 7, 2023 — In the case of compounding for animals, the Animal Medicinal Drug Use Clarification Act (AMDUCA) legalized compounding when done by manipulating approve