Express Scripts files suit against FTC, demands retraction of report on PBM industry
By Paige Minemyer
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
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.