https://www.irs.gov/compliance/criminal-investigation/doctor-admits-health-care-fraud-conspiracy
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, February 16, 2023
Lyons Magnus, LLC | Division of Human and Animal Food Operations West I | Low Acid Canned Food Regulation/Adulterated | ||||
American Cruise Lines | Division of Human and Animal Food Operations East V | Insanitary Conditions/Adulterated | ||||
Wintech Medipro LLC | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/PMA/Adulterated | ||||
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||||
Flavor Vapors, LLC/Mob Liquid Labs | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Clean Cosmetics LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
Tuesday, February 14, 2023
Pharmacy Decision Affirmed on Appeal Regarding rule relating to compounding preparations that are essential copies of commercial drugs Empower Drugs v. Iowa Board of Pharmacy
in the court of appeals of iowa
Announcement from Walter Reed regarding Compounded Drugs-Adopts Express Scripts Incorporated Commercial Reject List
"
Notice of Non-coverage for Certain Compounded Drugs
Posted February 13, 2023
A review by the Pharmacy Advisory Board of the Defense Health Agency (DHA) found compounded drugs, which traditionally accounted for a small proportion of pharmaceutical expenditures, grew to over $500 million by 2015. The dramatic increase was largely due to multiple fraudulent schemes related to drug compounding and billing.
To combat fraud and ensure patient safety, DHA adopted the Express Scripts Incorporated (ESI) Commercial Reject List. The ESI’s Commercial Reject List verifies that each ingredient is safe, effective, and covered by TRICARE. With the current implementation of the DHA’s new electronic health record, MHS GENESIS, only compounds recognized by ESI, covered for the indication prescribed, and approved for standardized use, will be compounded by National Capital Region (NCR) Market pharmacies...."https://walterreed.tricare.mil/News-Gallery/Alerts/Compounded-Medications
FDA updates ibuprofen compounding guidance | AHA News
Thursday, February 9, 2023
Wednesday, February 8, 2023
Opinion: Poodle's death after vet visit shows why Texas Vet Board needs revamp - The Dallas Morning News
https://apple.news/
Salon Technologies International, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | ||||
Mark S. Denker, M.D., PA dba Palm Beach Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
Quality Supplement Manufacturing, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | ||||
MicroVention Costa Rica S.R.L. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
Getsch+Hiller Medizintechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
J.M. Smucker LLC | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
AMO and Wing Inc. dba T and H Trading Co. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
HST Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
The Body Bean, LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List |