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H 3764 Session 120 (2013-2014)
H 3764 General Bill, By Long, K.R. Crawford, Powers Norrell, Knight, Erickson,
Barfield, Delleney, Dillard, Douglas, Gagnon, Henderson, Loftis, Newton, Pope,
Ridgeway, Spires, Stringer and Wood
A BILL TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, SO AS TO ENACT THE
"NONEMBRYONIC AND NONFETAL CELL THERAPY ACT" BY ADDING ARTICLE 15 TO CHAPTER
43, TITLE 44 SO AS TO AUTHORIZE THE ESTABLISHMENT AND OPERATION OF
NONEMBRYONIC AND NONFETAL CELL OR TISSUE BANKS; TO DEFINE NONEMBRYONIC AND
NONFETAL CELL FOR PURPOSES OF THE  ARTICLE; TO PROHIBIT STATE AND LOCAL
GOVERNMENTAL AUTHORITIES FROM REGULATING NONEMBRYONIC AND NONFETAL CELL OR
TISSUE BANKS OR FROM TAKING DISCIPLINARY ACTION OR IMPOSING PENALTIES OR CIVIL
OR CRIMINAL LIABILITY FOR ENGAGING IN ACTIVITIES AUTHORIZED BY THIS ARTICLE;
TO PROHIBIT LICENSING BOARDS FROM ABSOLVING THEMSELVES OF THE RESPONSIBILITY
TO REGULATE LICENSEES OR TO REGULATE PROCEDURES USED TO PERFORM THE ACTIVITIES
PERMITTED PURSUANT TO THIS ARTICLE; TO PROHIBIT IMMUNITY FROM PENALTIES OR
CIVIL AND CRIMINAL LIABILITY FOR INDIVIDUALS WHO FAIL TO EXERCISE REASONABLE
CARE IN PROVIDING SERVICES PURSUANT TO THIS ARTICLE; AND TO ESTABLISH
QUALIFICATIONS AND LIMITATIONS PERTAINING TO THE PURCHASE, COMPOUNDING,
DELIVERY, AND ADMINISTRATION OF NONEMBRYONIC AND NONFETAL CELLS.
03/06/13 House Introduced and read first time (House Journal-page 70)
03/06/13 House Referred to Committee on Judiciary
(House Journal-page 70)
05/30/13 House Committee report: Favorable Judiciary
(House Journal-page 10)
06/04/13 House Debate adjourned until Tues., 1-14-14
(House Journal-page 74)
01/15/14 House Debate adjourned until Thurs., 1-16-14
(House Journal-page 34)
01/16/14 House Debate adjourned until Tues., 1-21-14
(House Journal-page 245)
01/21/14 House Debate adjourned until Wed. 1-22-14
(House Journal-page 130)
01/22/14 House Amended (House Journal-page 17)
01/22/14 House Read second time (House Journal-page 17)
01/22/14 House Roll call Yeas-107 Nays-0 (House Journal-page 17)
01/23/14 House Read third time and sent to Senate
(House Journal-page 14)
01/23/14 Senate Introduced and read first time (Senate Journal-page 11)
01/23/14 Senate Referred to Committee on Medical Affairs
(Senate Journal-page 11)
H. 3764
AMENDED
January 22, 2014
H. 3764
Introduced by Reps. Long, K.R. Crawford, Norrell, Knight, Erickson, Barfield, Delleney, Dillard, Douglas, Gagnon, Henderson, Loftis, Newton, Pope, Ridgeway, Spires, Stringer and Wood
S. Printed 1/22/14--H.
Read the first time March 6, 2013.
A BILL
TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, SO AS TO ENACT THE "NONEMBRYONIC AND NONFETAL CELL THERAPY ACT" BY ADDING ARTICLE 15 TO CHAPTER 43, TITLE 44 SO AS TO AUTHORIZE THE ESTABLISHMENT AND OPERATION OF NONEMBRYONIC AND NONFETAL CELL OR TISSUE BANKS; TO DEFINE NONEMBRYONIC AND NONFETAL CELL FOR PURPOSES OF THE ARTICLE; TO PROHIBIT STATE AND LOCAL GOVERNMENTAL AUTHORITIES FROM REGULATING NONEMBRYONIC AND NONFETAL CELL OR TISSUE BANKS OR FROM TAKING DISCIPLINARY ACTION OR IMPOSING PENALTIES OR CIVIL OR CRIMINAL LIABILITY FOR ENGAGING IN ACTIVITIES AUTHORIZED BY THIS ARTICLE; TO PROHIBIT LICENSING BOARDS FROM ABSOLVING THEMSELVES OF THE RESPONSIBILITY TO REGULATE LICENSEES OR TO REGULATE PROCEDURES USED TO PERFORM THE ACTIVITIES PERMITTED PURSUANT TO THIS ARTICLE; TO PROHIBIT IMMUNITY FROM PENALTIES OR CIVIL AND CRIMINAL LIABILITY FOR INDIVIDUALS WHO FAIL TO EXERCISE REASONABLE CARE IN PROVIDING SERVICES PURSUANT TO THIS ARTICLE; AND TO ESTABLISH QUALIFICATIONS AND LIMITATIONS PERTAINING TO THE PURCHASE, COMPOUNDING, DELIVERY, AND ADMINISTRATION OF NONEMBRYONIC AND NONFETAL CELLS.
Amend Title To Conform
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Chapter 43, Title 44 of the 1976 Code is amended by adding:
"Article 15
Nonembryonic and Nonfetal Cell Therapy Act
Section 44-43-1510. This article may be cited as the 'Nonembryonic and Nonfetal Cell Therapy Act'.
Section 44-43-1520. As used in this article, and unless the specific context indicates otherwise:
(1) 'Allogeneic' means originating from the body of another person.
(2) 'Autologous' means originating from within a person's own body.
(3) 'Cell or tissue bank' means a facility that stores nonembryonic and nonfetal cells or tissues, or both.
(4) 'DHEC' means the South Carolina Department of Health and Environmental Control.
(5) 'FDA' means the United States Food and Drug Administration.
(6) 'Nonembryonic and nonfetal cells' means autologous or cellular material including, but not limited to, stem cells and immune cells that:
(a) have not been isolated or obtained by any means from human embryos or fetuses; and
(b) may have been or may be combined with one or more naturally occurring biomaterials or materials approved or cleared for any purpose by the FDA or other applicable agency or authority.
For purposes of this article nonembryonic and nonfetal cells include stem cells obtained from umbilical cord blood banking procedures.
Section 44-43-1530. (A) Notwithstanding another provision of law, no department, commission, board, or agency of the State or of a local government including, but not limited to, a professional board created pursuant to Title 40, may:
(1) except as otherwise provided in Sections 44-43-1550 and 44-43-1570, regulate the activities authorized under this article; or
(2) take disciplinary action or impose civil or criminal liability or penalties against a person for engaging in an activity authorized under this article.
(B) This section does not:
(1) absolve a professional licensing board of the duty to regulate licensees or otherwise prohibit or limit the powers and duties of a licensing board to regulate the procedures used to administer nonembryonic and nonfetal cells; or
(2) absolve a person of civil or criminal liability or penalty for failure to use the reasonable care, skill, or knowledge ordinarily used in rendering medical services under similar circumstances.
Section 44-43-1540. Nothing in this article indicates whether the activities authorized in this article are authorized under federal law.
Section 44-43-1550. Notwithstanding another provision of law, nonembryonic and nonfetal cells may be administered to a person by:
(1) that person himself or herself; or
(2) a physician licensed or authorized in this State by the South Carolina Board of Medical Examiners to practice medicine or health care to others if the mode of delivery used by the person to deliver the nonembryonic and nonfetal cells is a mode of delivery permitted under the person's license or authorization.
Section 44-43-1560. Notwithstanding another provision of law:
(1) a drug, medicine, or health product may be compounded using, as an ingredient by itself or with other ingredients, nonembryonic and nonfetal cells; and
(2) a pharmacy that compounds a drug, medicine, or health product described in item (1) may be owned or operated, or both, in this State.
Section 44-43-1570. Notwithstanding another provision of law:
(A) A person may import a compound, drug, or other treatment containing nonembryonic and nonfetal cells into this State if:
(1) the person obtained the compound, drug, or other treatment without violating the laws of the jurisdiction in which it was obtained; and
(2) the compound, drug, or other treatment is for personal use.
(B) A physician who is licensed or authorized in this State by the South Carolina Board of Medical Examiners to practice medicine or health care to others may administer, or assist in the administration of, to a person described in subsection (A)(1), the imported compound, drug, or other treatment to a person described in subsection (A) if the mode of delivery used to deliver the nonembryonic and nonfetal cells by the person who is licensed or authorized in this State is a mode of delivery permitted under the person's license or authorization."
SECTION 2. This act takes effect upon approval by the Governor.
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