H.F. _____ Section 1. NEW SECTION . 136E.1 Definitions. 1 As used in this chapter unless the context otherwise 2 requires: 3 1. “Adult stem cells” means autologous or allogeneic 4 cellular material including but not limited to stem cells, 5 immune cells, and other types of mature cells that may have 6 been or may be combined with naturally occurring biomaterials 7 or materials approved or cleared for any purpose by the United 8 States food and drug administration or other applicable agency 9 or authority. 10 2. “Allogeneic” means originating from the body of another 11 person. 12 3. “Autologous” means originating from a person’s own body. 13 4. “Cell or tissue bank” means a facility that stores adult 14 stem cells or tissue. 15 Sec. 2. NEW SECTION . 136E.2 Practices relating to adult 16 stem cells. 17 1. Notwithstanding any law to the contrary: 18 a. A person licensed to practice medicine pursuant to 19 chapter 148 in this state may extract, process, or administer 20 autologous adult stem cells. 21 b. A person licensed or authorized to administer or assist 22 in the administration of medicine or health care in this state 23 may extract, process, or administer autologous adult stem 24 cells to the extent permitted under the person’s license or 25 authorization. 26 c. A person may operate a cell or tissue bank in this state. 27 d. A pharmacy owned or operated in this state, or a 28 pharmacist licensed pursuant to chapter 155A, may compound a 29 drug, medicine, or health product using adult stem cells as an 30 ingredient. 31 e. A person licensed to practice medicine in this state may 32 conduct adult stem cell clinical research for development of 33 therapies and cures consistent with chapter 707C. This chapter 34 shall not be interpreted to limit or prohibit any activity 35 -1- LSB 2604YC (1) 84 pf/nh 1/ 4

H.F. _____ otherwise authorized pursuant to chapter 707C. 1 f. A person authorized to conduct adult stem cell clinical 2 research in the state may import into this state any compound 3 or drug containing adult stem cells if the compound or drug is 4 obtained in accordance with the laws of the jurisdiction from 5 which the compound or drug is obtained and the compound or drug 6 is used for the purposes of clinical research. 7 g. A person who is authorized to extract, process, or 8 administer autologous adult stem cells under this section 9 may import into this state compounds and drugs used in the 10 administration of such stem cells if the compound or drug is 11 obtained in accordance with the laws of the jurisdiction from 12 which the compound or drug is obtained and the compound or drug 13 is used for administration of autologous adult stem cells to a 14 person in a treatment plan by a person licensed or authorized 15 to extract, process, or administer autologous adult stem cells. 16 2. a. The board of medicine, the board of pharmacy, and 17 other appropriate licensing boards established pursuant to 18 chapter 147 shall adopt rules in accordance with this chapter. 19 The rules adopted shall not prohibit the activities authorized 20 in this chapter and shall not impose disciplinary action or 21 civil or criminal penalties against a person for engaging 22 in any activity authorized by this chapter. This paragraph 23 shall not be interpreted to authorize the adoption of rules 24 that absolve a person from civil or criminal liability or 25 disciplinary action otherwise applicable if the person engages 26 in an activity authorized under this chapter but fails to use 27 the reasonable care, skill, or knowledge ordinarily used in 28 rendering medical services under similar circumstances. 29 b. The board of medicine, the board of pharmacy, and other 30 appropriate licensing boards may adopt rules to regulate the 31 procedures used to administer adult stem cells in this state. 32 EXPLANATION 33 This bill relates to the use of adult stem cells in the 34 state, including uses relating to the practice of medicine, the 35 -2- LSB 2604YC (1) 84 pf/nh 2/ 4

H.F. _____ practice of pharmacy, and clinical research. 1 The bill defines terms used in the bill and authorizes 2 certain activities relating to adult stem cells. The bill 3 authorizes a person licensed to practice medicine in the state 4 to extract, process, or administer autologous adult stem cells. 5 “Autologous” means originating from the person’s own body. 6 The bill also provides that a person licensed or authorized 7 to administer or assist in the administration of medicine or 8 health care in this state may extract, process, or administer 9 autologous adult stem cells to the extent permitted under the 10 person’s license or authorization. 11 The bill authorizes all of the following: the operation 12 of a cell or tissue bank in this state; a pharmacy owned or 13 operated in the state or a licensed pharmacist to compound 14 a drug, medicine, or health product using adult stem cells 15 as an ingredient; a person licensed to practice medicine to 16 conduct adult stem cell clinical research for development of 17 therapies and cures consistent with Code chapter 707C (human 18 stem cell research and cloning) while clarifying that the 19 bill is not to be interpreted as limiting or prohibiting 20 any activity authorized under chapter 707C; a person who is 21 authorized to conduct adult stem cell clinical research to 22 import any compound or drug containing adult stem cells if 23 the compound or drug is obtained in accordance with the laws 24 of the originating jurisdiction and is used for clinical 25 research; and a person who is authorized to extract, process, 26 or administer autologous adult stem cells to import compounds 27 and drugs used in the administration of such stem cells if the 28 compound or drug is obtained in accordance with the laws of the 29 originating jurisdiction and the compound or drug is used for 30 administration of autologous adult stem cells to a person in a 31 treatment plan by a person licensed or authorized to extract, 32 process, or administer autologous adult stem cells. 33 The bill directs the board of medicine, the board of 34 pharmacy, and other appropriate licensing boards to adopt rules 35 -3- LSB 2604YC (1) 84 pf/nh 3/ 4

H.F. _____ in accordance with the bill, but provides that the rules shall 1 not prohibit the activities authorized in the bill and shall 2 not impose disciplinary action or civil or criminal penalties 3 against a person for engaging in any activity authorized 4 under the bill. However, the bill is not to be interpreted 5 to authorize the adoption of rules that absolve a person who 6 engages in an activity authorized under the bill from civil or 7 criminal liability or disciplinary action otherwise applicable 8 for failure to use the reasonable care, skill, or knowledge 9 ordinarily used in rendering medical services under similar 10 circumstances. The bill does authorize the board of medicine, 11 the board of pharmacy and other appropriate licensing boards to 12 adopt rules to regulate the procedures used to administer adult 13 stem cells in this state. 14 -4- LSB 2604YC (1) 84 pf/nh 4/ 4