A BILL TO BE ENTITLED
AN ACT to require certain tissue banks operating in north carolina to be accredited by the american association of tissue banks or the eye bank association of america.
The General Assembly of North Carolina enacts:
SECTION 1.  Chapter 131E of the General Statutes is amended by adding a new Article to read:
"Article 8A.
"Regulation of Tissue Banks.
"§ 131E‑ 171.  Registration and accreditation requirements.
(a)	Any tissue bank that recovers human tissue at a location outside of a hospital, when such tissue is intended for human transplantation, shall be registered with the Food and Drug Administration and accredited by the American Association of Tissue Banks (AATB), or accredited by the Eye Bank Association of America (EBAA), unless the establishment is an organ procurement organization that has been designated by the federal Secretary for Health and Human Services and is registered with the Food and Drug Administration as a tissue bank.
(b)	For purposes of this Article, 'human tissue' means musculoskeletal tissue, including bone, tendons, ligaments, fascia, cartilage, and related soft tissues, skin, cardiac tissue, dura mater, and ocular tissue. Human tissue in this Article shall not include oocytes, semen, embryos, or stem cells from peripheral blood or umbilical cord blood sources.
"§ 131E‑172.  Inspection, enforcement, penalties.
(a)	The Department is authorized to inspect the records of any tissue bank engaged in the recovery of human tissue for human transplantation in the State to ascertain compliance with the registration and accreditation requirements of this Article.
(b)	Notwithstanding the existence or pursuit of any other remedy, the Department may maintain an action in the name of the State for injunctive relief or other process against any tissue bank to restrain or prevent recovery of human tissue for human transplantation without the required registration or accreditation or otherwise restrain or prevent substantial noncompliance with this Article or the rules adopted pursuant to it.
(c)	If any person hinders the proper performance of duty of the Department in carrying out the provisions of this Article, the Department may institute an action in the superior court of the county in which the hindrance occurred for injunctive relief against the continued hindrance.
(d)	Any person who knowingly and willfully engages in the recovery of human tissue for human transplantation without registration with the Food and Drug Administration or accreditation by the AATB or EBAA as required by this Article is guilty of a Class 3 misdemeanor and upon conviction is liable only for a fine of not more than five hundred dollars ($500.00) for the first offense and not more than five hundred dollars ($500.00) for each subsequent offense."
SECTION 2. G.S. 90‑210.25 is amended by adding a new subsection to read:
"(e1)	No funeral establishment shall permit the recovery of human tissue from a dead human body in its custody and control except in accordance with Article 8A of Chapter 131E of the General Statutes."
SECTION 3.  This act becomes effective October 1, 2007, and applies to tissue banks engaged in the recovery of human tissue or cells for human transplantation on or after that date.