BLOGS

Did you know that FDA has begun citing deficiencies of drug manufacturers, wholesale distributors, repackagers, dispensers, and third party logistics providers (aka trading partners) for not complying with DSCSA? As a quick review, DSCSA was written into law on Nov 27, 2013 under Title II of the Drug Quality and Security Act in order for the FDA to protect the drug supplies for US consumers against counterfeit and illegitimate drugs, in particular prescription drugs. DSCSA

There are a few key areas about nitrosamines that you should know: A. There are two structural classes of nitrosamine impurities...

Effective 02/21/25, semaglutide ( Ozempic and Wegovy) drug shortage is finally resolved since its declaration of shortage since August 2022 especially when there had been an increase demand of weight loss use exceeding the supplies ( FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize | FDA ). In other words, compounders (503A and 503B) will have a certain off-ramp time to compound before they are no longer allowed by FDA to compound as drug c