58-4.4 Enforcement

(a) Registration under this Subpart may be denied, suspended, revoked or annulled by the department upon a determination that a registrant:

(1) failed to comply with the requirements of this Subpart; 

(2) provided services that constitute an unwarranted risk to human health; 

(3) intentionally provided any false or misleading information to the Department relating to registration or performing donor eligibility and collection procedures; or 

58-4.3 Incorporation by Reference

58-4.2 Registration of source plasma donation centers

(a) Each source plasma donation center must apply for registration on forms provided by the Department, which shall include: the necessary demographic information of the source plasma donation center; current license and registration of the responsible physician overseeing collection activities; name, address and credentials of the laboratory director; name and address of the owner of the donation center; and other such information as the department may require.

58-4.1 Definitions

(a) Source plasma is defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. This definition excludes single donor plasma products intended for intravenous use (i.e., transfusion).