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BLOGS


Drug Supply Chain Security Act (DSCSA) - the sheriff is already in town
Did you know that FDA has begun citing deficiencies of drug manufacturers, wholesale distributors, repackagers, dispensers, and third...
Binh Nguyen
May 4, 20252 min read
Nitrosamines on the run
There are a few key areas about nitrosamines that you should know: A. There are two structural classes of nitrosamine impurities...
Binh Nguyen
Apr 9, 20255 min read
Drug Shortages and Human Drug Compounding - a quick review.
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
Binh Nguyen
Feb 22, 20252 min read
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