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FDA Should Drop Ban On Office Compounding, US House Members Say

 
• By Joanne S. Eglovitch

Commissioner Gottlieb stands pat (actually he was sitting) during hearing where lawmakers suggest FDA has gone overboard in implementing DQSA. And while he acknowledges that '503 lite' isn't the best term to use, Gottlieb says agency’s plan to create different risk tiers for drug outsourcing pharmacies offers the flexibility that can entice more traditional pharmacies to register as outsourcing centers, and thus be subject to GMP oversight.

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The US FDA was admonished Jan. 30 by a score of lawmakers who argued that banning the practice of compounding drugs for office use and creating different risk tiers for drug outsourcing pharmacies to entice more traditional pharmacies to register are bad policies that could have negative implications for the public health.

But Commissioner Scott Gottlieb stood his ground during the hearing by House Energy and Commerce Subcommittee on Health, saying that the agency’s implementation of the Drug Quality Security Act (DQSA) is

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