Federal and state regulation of compounded drug products has dramatically increased, leaving traps for the unwary and unprepared.

Unprecedented regulation

Since 2012, FDA and states have engaged in unprecedented regulation of the compounded drug industry.  HPM is an industry leader on advising its pharmacy and outsourcing facility clients on FDCA Section 503A compliance, and compliance with Title I of the Drug Quality and Security Act (the Compounding Quality Act).  With HPM’s assistance, become and remain informed about legislative and regulatory developments, be prepared for regulatory visits, and respond effectively to FDA or state actions.  HPM works with outsourcing facilities and pharmacies in handling inspections, responding to state and federal inquiries, including but not limited to Form 483s, Warning Letters, and other communications.

Our services

  • Licensing
  • Inspection assistance
  • Responding to government inquiries
  • Responding to regulatory action, including 483s, Warning Letters, Untitled Letters, BOP matters