Wednesday, May 27, 2015

The FDA Answers Why Congress Was Concerned and Should be with Interstate Distribution Amounts of Compounded Drugs

Why is interstate distribution a concern? • State-licensed pharmacies primarily overseen by states • Congress did not intend for compounders operating under the exemptions in section 503A to grow into conventional manufacturing operations making unapproved drugs and operating a substantial portion of their business interstate • If a substantial proportion of a compounder’s drugs are distributed outside of a State’s borders, adequate regulation of those drugs can pose logistical, regulatory, and financial challenges to State regulators; can be difficult to investigate and address multi-state outbreaks • If a poor performing pharmacy locates in a state with inadequate controls, patients in other states are at risk

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