HDMA Asks FDA to Use Discretion to Evaluate Compliance With Drug Tracking Provisions

The Healthcare Distribution Management Association (HDMA) Dec. 15 sent a letter to the Food and Drug Administration calling for enforcement discretion when evaluating the drug supply chain’s compliance with tracking requirements that go into effect Jan. 1.

The Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. No. 113-54), which was signed into law in 2013 11 PLIR 1438, 12/6/13, requires drug trading partners such as manufacturers, wholesale distributors, dispensers and repackagers to capture, maintain and provide the subsequent purchaser with transaction information for certain prescription drugs. Manufacturers, wholesale distributors and repackagers must meet these ...