PDMA Compliance Policy
Guide 160.900

• Focus: Drugs most vulnerable to counterfeiting and diversion

• Final: Very minor changes from draft CPG

• Factors to consider by FDA field personnel regarding where they should target their enforcement efforts and prioritize resources.

• Risk-based focus with examples

  • High value in US market

  • Prior history of counterfeiting or diversion

  • Reasonable probability for new drugs

• Other violations of law

• NOT an excuse for non-compliance