Department of Justice
Friday, October 28, 2022
Department of Justice
Pharmacist Convicted for Health Care Fraud and Black-Market Prescription Drug Diversion Scheme
FDA Warnings on Fraudulent COVID-19 Products
FDA recently issued two warnings letters jointly with the Federal Trade Commission to companies selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19.Consumers concerned about COVID-19 should consult with their health care provider. FDA issued the following:
- Warning letter to Lakpura LLC for selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19.
- Warning Letter to Bespoke Apothecary LLC for selling unapproved and misbranded COVID kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19.
FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.
Wednesday, October 26, 2022
Ryan O'Neill Provides Insights On Compounded Drugs HIPAA ...
FDA extends grace period for 5 percent limit exemption on ...
Memorandum of Understanding Addressing Certain ... - FDA
|Lakpura LLC||Center for Drug Evaluation and Research | CDER||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|Advanced Cosmetic Research Laboratories Inc.||Division of Pharmaceutical Quality Operations IV||CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug|
|Ragin’ Vapors||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|RiteAid Corporation||Center for Drug Evaluation and Research | CDER||Failure to Comply with Drug Listing Requirements/Misbranded|
|Nicotine River LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Nephron SC Inc.||Office of Pharmaceutical Quality Operations, Division II||CGMP/Finished Pharmaceuticals/Adulterated|
|El Gordo Spices, LLC||Division of Human and Animal Food Operations West III||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions|
|Unit Dose Services, LLC||Center for Drug Evaluation and Research | CDER||Failure to Comply with Drug Listing Requirements|
Tuesday, October 18, 2022
HHS' civil rights division
is investigating practices at chain pharmacies Walgreens and CVS
following complaints about withheld prescriptions. As some states pass
abortion bans, patients report being denied medications if the drugs could harm a pregnancy, Dave Muoio reports.
Friday, October 14, 2022
FDA Moves to Pull Controversial Preterm Birth Drug From the Market — Briefing data show Makena was ineffective in reducing preterm birth, improving neonatal outcomes by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today October 14, 2022
Saturday, October 8, 2022
Older Therapies Aren't Necessarily Better for Thyroid ... - FDA
Friday, October 7, 2022
|Bulk Drug Substance (BDS)||Species||Nomination|
|Aluminum hydroxide||dog, cat||FDA‑2018‑N‑4626‑0048|
|Amikacin||dog, cat, horse||FDA‑2018‑N‑4626‑0032|
|Aminopentamide sulfate||dog, cat||FDA‑2018‑N‑4626‑0017|