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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