By Paige Minemyer
“ Emma Beavins reports that gridlock in the Biden administration on allowing schedule II substances, like Adderall for ADHD, to be prescribed via telehealth could roll back progress on virtual prescribing. Stakeholders fear time is running out to extend pandemic-era telehealth flexibilities before they expire.”
By Paige Minemyer
Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing business as Naternal, for illegally selling cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) products for people and pets. Naternal makes unproven claims their products can treat multiple diseases in people including Alzheimer’s disease, substance use disorder, autism and high blood pressure. Naternal also makes unproven claims their hemp extract oil products for pets can treat conditions such as separation anxiety, pain, arthritis and skin ailments. The Naternal products that are the subject of the warning letter are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The FDA requested a response from the company within 15 working days stating how they will correct the violations.
On Wednesday, the FDA issued a Dear Veterinarian letter describing Federal requirements related to a veterinarian’s role in dispensing prescription animal drugs and to the establishment of a veterinarian-client-patient relationship in the course of practice, including telemedicine.
| SoloVital | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | ||||
| MexHealth LLC d/b/a Al Natural E-Shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
The FDA has received questions from interested parties about Federal requirements related to a veterinarian’s role in dispensing prescription animal drugs and to the establishment of a veterinarian-client-patient relationship (VCPR) in the course of practice. The following Q&As only cover the veterinarian’s obligations under Federal law. Veterinarians should also consult their state licensing boards to determine if there are additional requirements at the state or local level.
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“ And ... the leaders of the three major PBMs are facing heat from key lawmaker Rep. James Comer for their testimony during a hearing last month. Under scrutiny are statements made about PBMs relationships with local pharmacies, Paige Minemyer reports. - Heather Landi”
https://pubmed.ncbi.nlm.nih.gov/39164199/
| Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Intercos Europe S.p.A | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |
In September 2023, the FDA unveiled our Animal and Veterinary Innovation Agenda to define our commitment to advancing human and animal health by supporting innovative products and approaches to real-world problems, prioritizing critical needs, streamlining and clarifying regulatory processes, and preparing the agency’s Center for Veterinary Medicine for the future. The Agenda describes some of the actions that we’re taking or proposing to take to help deliver the products that veterinarians, pet owners and animal producers need and to advance public health and sustainable food systems.
Since last fall, we’ve been busy initiating and continuing work on many of the key items described in the Agenda. I’m thrilled to share the progress we’ve made so far – and you can expect to see additional updates as we continue to evolve.
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| Central Admixture Pharmacy Services, Inc. | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products | ||||
| Txsyn Int. LLC | Division of Human and Animal Food Operations West III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | ||||
| Nowrez & Ismail Shukri Company | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| BullyKamp Products LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Top Dog Pet Store LLC dba The Bulldog Cartel | Center for Veterinary Medicine | Unapproved New Animal Drug Products | ||||
| Baylab USA, LLC | OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | ||||
| Globus Medical, Inc. | Office of Medical Device and Radiological Health Division I | CGMP/QSR/Drug/Medical Devices/Adulterated | ||||
| LS Promotions Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Konrad Rejdak, M.D., Ph.D. | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program/IRB |
