Posts Tagged ‘compounding’
PSM asks House Energy & Commerce Committee to oppose H.R. 5316, The Drug Shortage Compounding Patient Access Act
PSM sent a letter explaining how H.R. 5316 undermines critical patient safety protections.
[...]PSM signs letter of support for changes to Mississippi’s compounding pharmacy guidelines
The proposed updates aim to help address safety concerns created by pharmacies reselling compounded sterile drugs purchased from outsourcing facilities.
[...]What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]An FDA inspection revealed significant problems at Empower’s new outsourcing facility
After a November 2024 inspection, the FDA issued a Form 483 to Empower Clinic Services highlighting violations related to compounded drug manufacturing practices at its East Windsor, New Jersey facility.
[...]The End of GLP-1 Compounding
Federally-registered compounding facilities stopped making tirzepatide on May 22. This transition is significant for patients, and we at PSM think there are four things you should be watching for.
[...]Empower Pharmacy’s no good, very bad week
Articles in Endpoints News and the Houston Chronicle raise questions about the regulatory process for 503B compounding facilities.
[...]Over 100 million Americans just watched a misleading ad at the Super Bowl.
You could tell an American that they’re getting a compounded medicine and they would have no idea what that meant. That may be a legal disclosure, but that’s not good enough to protect patients who don’t know what the words mean.
[...]FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products
FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products.
[...]Patients face safety risks with counterfeit and compounded prescription weight-loss drugs
Officials are concerned about compounded weight-loss medicines as demand surges. Share this PDF to spread the news
[...]Patients face safety risks with counterfeit and compounded prescription weight-loss drugs
Patients face safety risks with counterfeit and compounded prescription weight-loss drugs Officials warn of counterfeit and compounding pharmacy concerns as demand for weight-loss medicines surges. Demand is skyrocketing for FDA-approved medicines that provide incredible benefits to patients living with diabetes and obesity. The injectables – GLP-1s like semaglutide and incretins that are commonly known as…
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