- Public Notification: Vail-Bon Jie Yang Wan (偉安解癢丸) contains hidden drug ingredients
- Public Notification: Gold Hard Steel Plus contains hidden drug ingredient
Thursday, July 11, 2024
Wednesday, July 10, 2024
Department of Justice News: U.S. Compounding, Inc. Pleads Guilty To Multiple Fraud Offenses And Company Vice President Indicted In Scheme To Distribute Drugs, including Veterinary Drugs, Nationally Using False Prescriptions U.S. Compounding, Inc., a Subsidiary of a Publicly Traded Company, Pled Guilty to Mail Fraud and Food, Drug, and Cosmetic Act Offense
Damian Williams, the United States Attorney for the Southern District of New York, and Christie M. Curtis, the Acting Assistant Director in Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), announced today that U.S. COMPOUNDING, INC. (“USC”), a subsidiary of DMK Pharmaceuticals Corporation, pled guilty to multiple fraud offenses before U.S. District Judge Arun Subramanian, and a former USC executive, SAM GLOVER, was charged in an Indictment with conspiring to violate the Food, Drug, and Cosmetic Act (“FDCA”). GLOVER was arrested this morning and is expected to be presented today before a U.S. Magistrate Judge in the Eastern District of Arkansas.
FBI Acting Assistant Director in Charge Christie M. Curtis said: “U.S. Compounding, Inc. and its former executive, Sam Glover, allegedly committed various frauds and violated the Food Drug and Cosmetic Act by falsifying prescription orders. Despite scrutiny by members of the company who suspected the orders were unverified, the company’s leadership continued to allow the requests and collect profits as a result. This investigation is part of the FBI’s larger effort to ensure that both individuals and organizations who devise complex fraud schemes are prevented from furthering their illegitimate arrangements and making money off mistruths.”
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| Laboratorio Magnachem International | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||
| reBom Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Warlock Vapes, LLC d/b/a Zuluvape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Alien Vape LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Choo's Enterprises Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Acidified Foods/Emergency Permit Control/Adulterated | |||
| Optikem International Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||
| New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||
| AG Essence, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||
| PepsiCo, Inc. | Division of Human and Animal Food Operations East VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||
| Fuyang Fuchunjiang Canned Food Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Low Acid Canned Food Regulation/Adulterated |
Tuesday, July 2, 2024
On Friday, the FDA's Center for Veterinary Medicine made available two webinars for stakeholders interested in FDA regulation of intentional genomic alterations in animals. The webinars focus on two guidance documents: final Guidance for Industry #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” and draft Guidance for Industry #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process.” The webinars provide historical background on the guidances and walk through the details of what they cover. These and other webinars are available in the agency’s Animal Biotechnology Products Resource Center.
Wednesday, June 26, 2024
The Death of the American Pharmacy
The Death of the American Pharmacy
Bartell’s, a beloved Seattle drugstore now owned by debt-laden Rite Aid, is closing many of its locations. Its demise is the latest symptom of a national health care crisis that hurts all of us.Read in FORTUNE: https://apple.news/
FDA and European Medicines Agency Announce Updates to Parallel Scientific Advice Program for New Animal Drugs
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) and the European Medicines Agency (EMA) are announcing today recent updates to the Parallel Scientific Advice (PSA) program for new animal drug products to increase harmonization and facilitate development of new products to support animal health.
The animal drug industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of drug product development. The PSA program allows for animal drug sponsors to engage in concurrent scientific conversation with both agencies, the FDA and the EMA, on key issues during the development phase of new animal drug products.
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Tuesday, June 25, 2024
FDA Announces Final Guidance for Heartworm Disease Prevention Products for Dogs
On June 25, 2024, the FDA announced the availability of final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized.
In the final guidance, the FDA clarified the discussion and recommendations related to geographic locations, laboratory dose confirmation studies, and field effectiveness studies. The agency also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with the FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. The guidance announced in this notice finalizes the draft guidance dated November 30, 2022.
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