Public Health Service Laws on Quarantine, Inspection and Licensing of Biological Products

Facilities that transfer or receive certain biological agents must be registered. Biological agents include viruses, bacteria, rickettsiae, fungi, toxins, and recombinant organisms/molecules. Prior to transfer of any covered agent, a Center for Disease Control (CDC) Form EA-101 must be completed for each transfer. In addition, the transferor must verify that the requester's facility has a current registration, verify that the intended use of the agent is correctly indicated on CDC Form EA-101, and provide a copy of Form EA-101 to the registering agency. Penalties for violating this requirement go up to $250,000 per individual and $500,000 per organization.

Responsible office: 
Keywords: