Indiana Code Title 16. Health § 16-41-12-16

Sec. 16. (a) It is unlawful to operate a blood center in Indiana without a license issued by the state department under this chapter.  A blood center that applies for a license in Indiana must also be licensed or appropriately registered by the federal Food and Drug Administration and remain in compliance with all applicable federal regulations.

(b) An application for a license must be made on a form prescribed by the state department and must be accompanied by a license fee established by the state department.

(c) After inspection of an applicant's facility, if the state department finds that the applicant has complied with this chapter and the rules adopted under this chapter, the state department shall issue a license to the applicant.

(d) A license expires one (1) year after the date of issuance unless the license is renewed.  A blood center may submit a renewal application on a form prescribed by the state department.  The procedure and conditions for renewal are the same as the procedure and conditions established for the issuance of the original license.

(e) A person who inspects an applicant's facility under this section must have knowledge in blood banking and the nationally accepted standards of practice.

(f) For the purposes of this chapter, a hospital licensed under IC 16-21-2 that operates a blood center within the facility is subject to the rules adopted under this chapter concerning the operation of the blood center.  However, the hospital may be licensed only under IC 16-21-2 and shall be surveyed concurrently, for licensure purposes, as a blood center and a hospital.