Posts Tagged ‘FDA’
FDA and NABP Partnership: Information-Sharing for Drug Compounding
The Food and Drug Administration (FDA) recently announced that it awarded a cooperative grant to the National Association of Boards of Pharmacy (NABP) to create an information-sharing data system to improve the information available to state regulators and the FDA about state-licensed pharmacies that engage in interstate distribution of compounded drugs. The new data system…
Read MoreFDA and FTC Issue Joint Warning to Pharmacy Selling Unapproved Products containing CBD
Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a warning letter to Rooted Apothecary LLC (Rooted Apothecary) for illegally marketing and selling unapproved cannabidiol (CBD) products with unsubstantiated claims that these products treat teething and ear pain in infants, autism, attention-deficit/hyperactivity disorder (ADHD) and Parkinson’s and Alzheimer’s…
Read MoreNew Colorado Law Allows Doctors to Recommend Medical Marijuana for Disabling Medical Conditions
Colorado lawmakers passed Senate Bill 19-013 (Concerning the Conditions for Medical Marijuana Use For Disabling Conditions, and, in connection therewith, Adding a Condition for Which a Physician Could Prescribe an Opioid to the List of Disabling Medical Conditions for Medical Marijuana Use) in May 2019 and it took effect August 2, 2019. Senate Bill 19-013 allows doctors…
Read MoreFDA Issues Warning Letter to Curaleaf Over Its CBD Products
Last week, the Food and Drug Administration (FDA) sent a regulatory ‘Warning Letter‘ to Curaleaf, Inc. (Curaleaf) regarding its cannabidiol (CBD) containing products. CBD and tetrahydrocannabinol (THC) are two natural compounds found in cannabis or marijuana plants. CBD is a non-psychoactive compound, meaning that it doesn’t produce the high or sense of euphoria associated with…
Read MoreNABP Statement on Prescription Drug Importation Proposals
Last month the National Association of Boards of Pharmacy (NABP) released a ‘Statement on Prescription Drug Importation Proposals‘ reiterating its stance that prescription drug importation is not a viable solution to addressing high prescription drug costs. The NABP statement is in response to recent policymaker proposals seeking to allow (1) the importation of prescription drugs…
Read MoreFDA Cracks Down on Dietary Supplements
Yesterday, Dr. Scott Gottlieb, the Food and Drug Administration’s Commissioner, announced a new plan to crack down on dietary supplement makers who claim their products can prevent, treat or cure certain diseases. Gottlieb revealed the FDA sent twelve warning letters and five advisory letters to companies whose products are being illegally marketed as unapproved new drugs…
Read MoreFDA Approves Potent New Opioid Sulfentanil Despite Abuse Warnings
Yesterday, the Food and Drug Administration (FDA) approved the drug Dsuvia (Sulfentanil – sublingual 30mcg tablet), a potent synthetic opioid, for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings such as hospitals, surgical centers and emergency departments. Intravenous Sulfentanil has been used…
Read MoreEpidiolex (Cannabidiol) is a Schedule V Controlled Substance
Yesterday, the Drug Enforcement Administration announced that Epidiolex, which contains cannabidiol (CBD), a chemical constituent of the cannabis or marijuana plant is a Schedule V Controlled Substance, which is the least restrictive schedule of the Controlled Substance Act. In June 2018, the Food and Drug Administration announced it approved Epidiolex (cannabidiol), for the treatment of…
Read MoreFDA and Responsible Opioid Prescribing for Pain Management in Animals
The Food and Drug Administration (FDA) continues to address the opioid epidemic on all fronts with regards to prescribing opioids in humans. But, last month, the FDA introduced a new resource containing information and recommendations specifically for veterinarians who stock and administer opioids. The FDA recommends veterinarians take the following steps if they stock and…
Read MoreFDA’s Efforts to Advance Antimicrobial Stewardship in Veterinary Settings
Antimicrobial drugs, when used correctly, fight infections, but when antimicrobials are overused or misused, they promote antimicrobial resistant bacteria. Efforts at implementing good antimicrobial stewardship practices have been a mainstay in human healthcare for years and remains a top priority of the Food and Drug Administration (FDA). However, over the passed few years the FDA…
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