State Senate OKs bill giving more authority to veterinarian ...
... would have allowed veterinarian technician specialists to prescribe drugs, ... was compounded by the fact that many animal medicine doctors are women,...
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 23, 2023
Maryland man gets probation for role in insurance fraud ring run by Arkansans
Maryland man gets probation for role in insurance fraud ring run by Arkansans: A Maryland man accused of being part of a conspiracy federal authorities said bilked the U.S. military insurer TRICARE out of millions of dollars in payments for fraudulent prescriptions was sentenced to three years' probation Thursday and ordered to perform 100 hours of community service.
| Desert Defense, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Sohgave LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
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
7 days ago — Compounded drug products serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as a patient who has ..https://www.iowacourts.gov/courtcases/17360/embed/CourtAppealsOpinion
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
FDA updates ibuprofen compounding guidance | AHA News: The Food and Drug Administration yesterday revised its recent guidance for outsourcing facilities compounding certain ibuprofen oral suspension products.
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 |
PrimeZen Black 6000 contains hidden drug ingredients
FDA is notifying consumers of a product promoted for sexual enhancement that has been found to contain hidden ingredients and might pose a significant health risk: PrimeZen Black 6000 contains hidden drug ingredients. FDA laboratory analysis confirmed that PrimeZen Black 6000 contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approvals of Viagra and Cialis are restricted to use under the supervision of a licensed health care professional. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.
Learn Mor
Friday, February 3, 2023
MANNERS Energy Boost contains hidden drug ingredient
FDA is notifying consumers of a product promoted to boost energy that has been found to contain a drug hidden ingredient and might pose a significant health risk. MANNERS Energy Boost contains tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.
Learn More
Thursday, February 2, 2023
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