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Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
Telehealth companies selling compounded drugs are making modest inroads into the market for popular weight loss drugs that Big Pharma spent decades and billions of dollars to develop and bring to market. The compounded...more
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in the FDA’s lists of drug...more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
In recent years, various federal agencies, including the Department of Health and Human Services Office of the Inspector General and the U.S. Food and Drug Administration (FDA), have increasingly scrutinized compounded...more
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more
At its August 31, 2021 meeting, the Nevada Board of Pharmacy moved to seek a formal opinion from the Nevada Attorney General Office regarding the legality of the requirement of all non-resident pharmacists who dispense or...more
If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled...more
Previously, Drugs Manufactured by Outsourcing Facilities Were Largely Unregulated - The fungal-meningitis outbreak of 2012, which infected over 750 patients across the country and caused 60-plus deaths, became a turning...more
WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more
Compound prescription drugs have increasingly become a target for DOJ health fraud enforcement activities. ...more
In response to the federal and state declarations of public health emergencies surrounding the COVID-19 pandemic, the California State Board of Pharmacy has issued the following waivers to California Board of Pharmacy...more
Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more