The Oklahoma Department of Pharmacy has revised surety bond requirements for wholesale drug distributors to align with federal law. The Drug Quality and Security Act (DQSA), signed into law by President Obama in 2013, grants the FDA more authority to regulate and monitor compounded drugs. In Title II of the DQSA, the Drug Supply Chain Security Act (DCSCA) introduces a ten-year plan to build an electronic system to identify and trace certain prescription drugs as they are distributed throughout the United States.

The DSCSA also requires wholesale drug distributors to purchase a $100,000 surety bond or other security of equal value. If the wholesaler’s annual gross receipts for the previous tax year total less than $10,000,000, only a $25,000 bond is required. The new requirement amends Section 535:20-7-4 of the Oklahoma Administrative Code. Previously, wholesale drug distributors in the state were only required to post a $10,000 surety bond. The surety bond is in place to protect consumers from financial harm if the wholesaler violates any of the provisions of the DSCSA or of Title 535 of the Okla. Admin. Code.

The FDA provides an in-depth look at the new federal regulations and has released industry guides on the DSCSA’s implementation and how to comply with the new regulations.

To learn more about becoming a wholesale drug distributor in Oklahoma or to learn more about the new bond requirement, contact the State Board of Pharmacy.