• Dean Erhardt

Drug Supply Chain Security Act (DSCSA)

The Impact on Virtual Manufacturers



An interesting aspect of industry changes is the law of unintended consequences. Such is the impact of the Drug Supply Chain Security Act, (DSCSA). Enacted in 2013 DSCSA has had a dramatic impact on State Licensing requirements for Virtual Manufacturers. In 2015, Virtual Manufacturers were required to have 21 state licenses, in 2017 that number was 27 and today, that number is 37. BELIEVE IT, 37 states require Virtual Manufacturers to have a license in order to distribute their FDA approved product. That said, the majority of Virtual Manufacturers have not revisited this issue since they obtained their initial approval. Further many emerging companies are only vaguely aware of state licensure requirements.

Why does this happen? Resources! Most virtual manufacturers are unable to stay current on changes that occur on a state-by-state basis. Also, many states don’t publish these changes, but rather they change their “interpretation” of statues which changes their ongoing requirements.

D2 is currently offering a quick, inexpensive review of your current state licensing status. Contact us to learn more. www.d2rx.com



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