Friday, March 26, 2021
Thursday, March 25, 2021
FDA announced in October 2020 the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products became available for signature by the states. This MOU is an agreement between state boards of pharmacy or other state agencies and FDA. The MOU addresses interstate distribution of inordinate amounts of compounded drugs and complaint investigation by a state regulator relating to compounded drugs distributed outside the state.
Tuesday, March 23, 2021
Department of Justice
Pharmacist Charged in $4 Million Health Care Fraud and Kickback Scheme
Whistleblower came forward to report fraud and then was indicted Walter Simmons filed a whistleblower lawsuit, alleging that North Texas pharmacies and marketers paid kickbacks to doctors to prescribe unneeded pain cream to soldiers. Prosecutors say he was one of those doctors who were paid.
PDA to Collaborate with Deloitte and U.S. FDA to Improve the ...
Prescription meds pushed in kickback scheme, feds say ...
|03/23/2021||03/05/2021||Panther James LLC||Division of Human and Animal Food Operations East VI||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions|
|03/23/2021||03/10/2021||Aman Kapoor In||Division of Northern Border Imports||Foreign Supplier Verification Program (FSVP)|
|03/23/2021||03/18/2021||DEPQ Internacional S. de R.L de C.V.||Center for Drug Evaluation and Research||Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated|
|03/23/2021||01/25/2021||PYRLess Group, LLC dba Dr. Fitt||Center for Food Safety and Applied Nutrition||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|03/22/2021||03/15/2021||Honest Globe, Inc.||Division of Pharmaceutical Quality Operations IV||CGMP/Finished Pharmaceuticals/Adulterated|
|03/22/2021||03/18/2021||BioLyte Laboratories, LLC||Division of Pharmaceutical Quality Operations III||CGMP/Finished Pharmaceuticals/Adulterated|
|03/19/2021||03/19/2021||Vapor Outlet Inc d/b/a Union Hills Vape Shop||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/19/2021||03/19/2021||Vapor Tech Hawaii, Inc.||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/19/2021||03/19/2021||The Vaporium||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/16/2021||03/10/2021||Foshan Biours Biosciences Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated|
|03/16/2021||03/10/2021||Dibar Nutricional S. de R.L. de C.V.||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated|
|03/16/2021||03/11/2021||Albek de Mexico S.A. de C.V.||Center for Drug Evaluation and Research||Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated|
|03/16/2021||03/16/2021||Little Town Vaping d/b/a Swamp Vapor Lafayette||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/16/2021||03/16/2021||Little Town Vaping d/b/a Swamp Vapor||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/16/2021||03/16/2021||Little Town Vaping d/b/a Swamp Vapor New Iberia||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|03/15/2021||03/12/2021||Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials||Center for Drug Evaluation and Research||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to PYRLess Group, LLC dba Dr. Fitt for selling unapproved products with fraudulent COVID-19 claims. The FDA requested that the company take immediate action to cease the sale of any unapproved and misbranded products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care providers.
Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations
The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.
“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”
The FDA issued warning letters to:
The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.
Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.
The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.
The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.