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FDA Works To Encourage Office-Use Compounding In Advance Of Legislation

Executive Summary

FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.

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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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