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FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing and Foreign API Registration Changes Could Mean for Pharma Compliance

posted 7 days ago
In the wake of the Food & Drug Administration’s (FDA) ambitious unified agenda, on July 13, 2026, the agency published a proposed rule aiming to align its regulatory frameworks with “how distributed manufacturing actually works.” The proposed rule would create a tailored drug establishment registration framework for certain distributed manufacturing establishments (DMEs) and clarify the registration and listing obligations applicable to certain foreign drug establishments. Read Article #DSCSAGuidance

Two New Jersey Men Sentenced for Fentanyl Analogue Distribution in Homeland Security Task Force Investigation

posted 12 days ago
Two New Jersey men were sentenced this week for their roles in a drug trafficking organization that imported fentanyl analogues from China and distributed them in pill form throughout Northern New Jersey.Nine individuals have been charged and convicted for their roles in this drug trafficking organization. In total, they imported over a metric ton of fentanyl-related substances and other drugs into the United States and sent hundreds of thousands of dollars to China using wire transfers and Bitcoin to pay for the drugs. Thus far, five individuals have been sentenced to a total of 685 months in prison. On July 7, Sean Tighe, 50, of North Haledon, New Jersey, ...

Founder/CEO and Clinical President of Digital Health Company Sentenced to 72 Months and 24 Months, Respectively, for $90 Million Scheme to Distribute over 37 Million Pills of Adderall

posted 14 days ago
Health Care Fraud Unit Secures Result in Landmark Case Targeting Executives of Fraudulent Mental Health Technology Company The founder and former Chief Executive Officer (CEO) Ruthia He of Done Global Inc., a California-based digital mental health company, was sentenced today to six years in prison and a fine of $1 million for orchestrating a scheme that used her company’s technology platform, compensation structure, and clinical protocols to unlawfully distribute over 37 million pills of Adderall, defraud insurers of over $12 million, and obstruct the federal investigation that followed. The defendant spent over $40 million on social media advertisements ...

DEA to Temporarily Schedule 7-OH and Related Substances to Protect Public Safety

posted 20 days ago
WASHINGTON – Today, the U.S. Drug Enforcement Administration filed its intent to temporarily place 7-hydroxymitagynine (7-OH) and three related substances into Schedule I of the Controlled Substances Act (CSA). Prior to DEA issuing this notice, the Department of Health and Human Services (HHS) confirmed synthetic 7-OH, and the three related substances have no accepted medical use and a high potential for abuse. Two Notices of Intent (NOI) were sent to the Federal Register on Wednesday, July 1, 2026. One NOI addresses 7-OH above a specified threshold. The second NOI addresses moving 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, ...

Alibaba Group and AUS Merchant Services Agree to Pay $600 Million to Resolve Allegations that they Failed to Prevent Illegal Sales of Pharmaceuticals, Pharmaceutical Equipment, and Other Illegal Products

posted 20 days ago
Alibaba Group Holding Limited (Alibaba) — one of China’s largest companies — and its U.S.-based payment processor, AUS Merchant Services Inc. (AUS, and formerly known as Alipay US), have entered a non-prosecution agreement to pay $600 million to resolve the Justice Department’s allegations that they violated the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to prevent merchants from selling and importing illegal pharmaceuticals, controlled substances, listed chemicals, and pill presses into the United States through the Alibaba.com and AliExpress.com e‑commerce platforms. Alibaba operates e-commerce platform Alibaba.com, one of the world’s largest ...

Massachusetts Couple Sentenced to Prison for Importing Misbranded Drugs From China and Selling Them to Customers in U.S. for Performance Enhancing Purposes

posted 20 days ago
The defendants earned more than $600,000 from the sales of illegally misbranded drugs, repackaging and selling them for the use of preventing aging; improving sexual performance; and increasing cognitive function BOSTON – A Massachusetts couple have been sentenced in federal court in Boston for conspiring to introduce misbranded drugs into interstate commerce with intent to defraud and mislead. Chenguang Gong, 43, and Yalan Tang, 45, both of Belmont, Mass., were each sentenced by U.S. District Court Richard G. Stearns to one year and one day in prison, to be followed by one year of supervised release. In January 2026, the defendants pleaded guilty to one count ...

Telemedicine Company Owner and Author of Health Care Compliance Books Sentenced for $136M Medicare Fraud Scheme

posted 21 days ago
The owner of two telemedicine companies was sentenced today to 120 months in prison and ordered to pay $66 million in restitution for her role in a scheme to fraudulently bill Medicare for medically unnecessary durable medical equipment and prescription drugs. According to court documents and statements made in court, Jean Wilson, 54, of Richmond Hill, Georgia, is a licensed nurse practitioner who owned and operated two telemedicine companies between 2017 and 2019. Through these companies, Wilson and others paid illegal kickbacks to medical providers to sign orders for orthotic braces and prescriptions for pharmaceutical drugs for Medicare beneficiaries, even ...

Statement from DEA Administrator Terrance C. Cole Regarding Request for an Independent Review

posted 26 days ago
The Drug Enforcement Administration exists to protect the American people. Fulfilling that mission requires not only aggressive action against the criminal organizations trafficking deadly drugs into our communities, but also accountability and public trust. Today, I requested that the U.S. Department of Justice Office of the Inspector General conduct an independent review of DEA’s actions in connection with an investigation that has become the subject of public allegations. I made this request because allegations involving a federal law enforcement agency should be examined independently, thoroughly, and based on the complete factual record – not debated ...

Partnership for Safe Medicines Releases Action Plan to Protect Patients from Unapproved Knockoff GLP-1s

posted 26 days ago
The Partnership for Safe Medicines today published a report outlining solutions to protect patients from the risks of a growing compounded GLP-1 marketplace. A Call to Action: Restoring and Strengthening America’s Patient Safety System serves as a detailed plan for policymakers and regulators to uphold the gold standard system that protects Americans from untested and unsafe medicines. Read Article #GLP-1 #SafetyAlerts

Fake Cancer Medicines Have Reached US Clinics And Most Providers Don’t Know It

posted 27 days ago
Providers in high-income countries underestimate the domestic scale of falsified medicine. Read Article #Counterfeit #PatientHarm

National Health Care Fraud Takedown Results in 455 Defendants Charged in Connection with Over $6.5 Billion in Alleged Fraud

posted 28 days ago
Record Medicaid Fraud Charges Largest Number of States Participating in Health Care Fraud Takedown History The Justice Department today announced the 2026 National Health Care Fraud Takedown, which resulted in charges against 455 defendants, including 90 doctors and other licensed medical professionals, for their alleged participation in health care fraud and opioid abuse schemes involving over $6.5 billion in false claims and significant patient harm, including death. Today’s Takedown represents a new era in federal, state, and international cooperation to combat health care fraud: cases in 56 federal districts and 45 U.S. states and territories, ...

CBP officers seize over $10.1 million in methamphetamine at World Trade Bridge

posted 29 days ago
U.S. Customs and Border Protection officers at the World Trade Bridge seized narcotics that totaled over $10,122,000 in street value. The seizure occurred on Monday, June 15, 2026, at the World Trade Bridge, when a CBP officer referred a 2013 D-13 Volvo hauling a shipment manifested as “polypropylene” for secondary inspection. Following a canine and nonintrusive inspection system examination, CBP officers discovered a total of 1,100.79 pounds of suspected methamphetamine within the commodity. The narcotics have a street value of $10,122,012. Packages containing 1,100.79 pounds of methamphetamine seized by CBP officers at World Trade Bridge. CBP seized ...

3 officers hospitalized after drug exposure at B.C. prison, union says

posted 29 days ago
Three correctional officers were hospitalized after being exposed to illicit drugs at a federal prison in B.C.’s Fraser Valley earlier this month, according to their union. Read Article #Canada #Officer-DrugExposure #SyntheticStimulant #Fentanyl #Jail/Prison

Nurse Practitioner Sentenced to 87 Months in Prison for $12M Medicare Fraud

posted 06-17-2026
A Louisiana nurse practitioner was sentenced today to 87 months in prison and three years of supervised release for causing over $12 million in false and fraudulent claims to Medicare for medically unnecessary cancer genetic tests. She was also ordered to pay $1,508,868.25 in restitution. According to court documents and evidence presented at trial, Scharmaine Lawson Baker, 59, of Fulshear, Texas, a licensed nurse practitioner and Medicare provider, received tens of thousands of dollars in illegal kickbacks in exchange for ordering expensive cancer genetic tests. Lawson Baker held herself out as an expert in Medicare regulations — authoring books on medical ...

Maryland Man Sentenced in D.C. to 42 Months in Trafficking Counterfeit Oxycodone

posted 06-12-2026
Daijon West, 29, of Prince George’s County, Maryland, was sentenced today in U.S. District Court to 42 months in connection with a years-long conspiracy to distribute fentanyl-laced counterfeit oxycodone pills in the Washington, D.C., area, announced U.S. Attorney Jeanine Ferris Pirro. West pleaded guilty on Feb. 5, 2026, to conspiracy to distribute fentanyl. In addition to the prison term, Judge Rudolph Contreras ordered West to serve 4 years of supervised release. Federal prosecutors had requested a 68-month prison sentence. According to court papers, West distributed fentanyl-laced counterfeit oxycodone pills in the Washington region during a period ...

Mustang Man Charged with Distributing Synthetic Opioid Resulting in Death

posted 06-04-2026
A federal indictment has been unsealed, charging SHANE MICHAEL BURGESS, 24, of Mustang, Oklahoma, with distributing a controlled substance analogue resulting in death, announced United States Attorney Robert J. Troester. According to the Indictment, on December 12, 2025, Burgess distributed a substance containing N-Propionitrile Chlorphine, a synthetic opioid known as cychlorphine, to another individual. The Indictment further alleges that the recipient died as a result of using the cychlorphine distributed by Burgess. On June 2, 2026, a federal grand jury charged Burgess with distribution of a controlled substance analogue resulting in death. If found ...

Nurse Practitioner Convicted for Illegal Distribution of Controlled Substances

posted 06-02-2026
A federal jury in the Middle District of Tennessee convicted a Tennessee woman yesterday for illegally distributing controlled substances. According to court documents and evidence presented at trial, Heather Marks, 43, of Murfreesboro, Tennessee, was an Advanced Registered Nurse Practitioner who was licensed by the Drug Enforcement Administration (DEA) to distribute controlled substances. Marks prescribed controlled substances to patients seeking pain treatment at Lifeforce Pain and Wellness (Lifeforce), a pain clinic located in Carthage, Tennessee. Lifeforce was a small, rural clinic that purported to provide pain treatment. From September 2016 through May ...

AI Drug Monitoring System Failed to Detect Nurse’s Fentanyl Theft at Tennessee Hospital

posted 06-01-2026
An AI-powered medication monitoring system failed to detect months of fentanyl theft by a nurse at Tennessee’s largest hospital in Chattanooga, according to state nursing board records that raise questions about the effectiveness of artificial intelligence systems used in hundreds of American hospitals. Read Article #NurseDiversion #HealthcareDiversion

Large-Scale Counterfeit Pill Manufacturer Sentenced to 13 Years in Federal Prison

posted 05-29-2026
Defendant sought to import kilograms of fentanyl precursor chemicals into the U.S. and obtained $40,000 in fraudulent PPP loans BOSTON – A Cambridge, Mass. man was sentenced today in federal court in Boston in connection with an investigation of large-scale manufacturing of counterfeit pills containing fentanyl and methamphetamine. Defendant communicated directly with illegal chemical supplier in China. Schuyler Oppenheimer, a/k/a “SK,” a/k/a “Michael Sylvain,” 35, was sentenced by U.S. Senior District Court Judge F. Dennis Saylor IV to 13 years in prison, to be followed by five years of supervised release. In January 2026, Oppenheimer pleaded guilty to one ...

Clinic Manager Convicted of $8M Medicare Fraud Scheme

posted 05-28-2026
A federal jury in the Eastern District of New York convicted a New York woman today for her role in an $8 million health care fraud conspiracy. According to court documents and evidence presented at trial, Olga Popovych, 43, of New York, New York, was an office manager of several physical therapy clinics that paid cash kickbacks to ambulette drivers who recruited Medicare patients to bring to the clinics. As the evidence at trial showed, the defendant was personally involved with paying the ambulette drivers cash kickbacks. She also falsified medical records to indicate that physical therapists who were not actually at the clinic treated the patients. Between ...