HB 313 — Voluntary Registration of Stem Cell Providers

1271, Human Cells, Tissues, and Cellular and Tissue-Based Products, in the performance of any procedure using or b.purporting to use stem cells or products containing stem cells.

Materials(3) approvedA manufacturer or cleareddistributor byof thestem Unitedcells Statesor Foodproducts andcontaining Drugstem Administrationcells who advertises, distributes, or otheroperates applicablein agencythis orstate authority.may register with the department.

(f)(4) "StemThe celldepartment bank"shall meansestablish aand facilitymaintain thatan storesonline nonembryonicregistry stemaccessible cells.on its website which identifies the physicians, manufacturers, and distributors registered under this section and which documents physician agreements to adhere to the current applicable good manufacturing practices.

(3)The Nonembryonicdepartment stemshall cellsupdate maythe beinformation administeredcontained toin athe personPage by:2 of 3 CODING:

(a) Himself or herself;

or (b) A person licensed or authorized in this state to administer or assist in the administration of medicine or health care if such person administers or assists in the administration of the nonembryonic stem cells using a mode of administration permitted under his or her license or authorization.

(4) A health care product may be compounded using nonembryonic stem cells as a sterile ingredient either by themselves or in combination with other sterile ingredients.

A pharmacy that compounds a drug, medicine, or health care product using nonembryonic stem cells may be owned or operated, or both, in this state.

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hb0313-00hb0313-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HBCS/HB 313 2020 (5)(a)registry Aat personleast maymonthly. import into this state any sterile compound, drug, or other treatment containing nonembryonic stem cells if such compound, drug, or other treatment:

1.(5) The department may adopt rules to implement this section.

Was obtained without violating the laws of the jurisdiction in which it was obtained;

and 2.

Is for personal use.

(b) A person licensed or authorized in this state to administer or assist in the administration of medicine or health care may administer or assist in the administration of the imported sterile compound, drug, or other treatment containing nonembryonic stem cells if such person administers or assists in the administration of such compound, drug, or other treatment using a mode of administration permitted under his or her license or authorization.

(6)(a) Notwithstanding any other provision of law, a stem cell bank may operate in this state.

(b) Before organizing or arranging for the operation of a stem cell bank in this state, a stem cell bank must register with the department by submitting a department-approved registration form that contains:

1.

The name, street address, and telephone number of the stem cell bank.

2.

The name, street address, and telephone number of each officer, director, or organizational official of the stem cell bank who is responsible for the operation of the stem cell bank.

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words underlined are additions.

hb0313-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 313 2020 3.

Identification of the types of human tissue used in business or research at the stem cell bank.

4.

Identification of the product names produced at the stem cell bank for distribution.

5.

Any other information required for registration by the department.

(c) Each stem cell bank shall notify the department in writing of any change in the information required for registration not later than 10 days after such change goes into effect.

(d) Each stem cell bank that operates in this state must obtain or otherwise carry, before engaging in such business, a policy of professional liability insurance that insures the stem cell bank against any liability arising from the operation of such business.

(7) This section does not absolve:

(a) A professional licensing board of the duty to regulate licenses or otherwise prohibit or limit the powers and duties of a licensing board to regulate the procedures used to administer nonembryonic stem cells.

(b) Any person of civil or criminal liability or penalty for failure to use the reasonable care, skill, or knowledge ordinarily used in rendering health care services or administering health care products under similar circumstances.

(8) The department shall adopt by rule standards developed Page 5 of 6 CODING:

Words stricken are deletions;

words underlined are additions.

hb0313-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 313 2020 by an independent third party to ensure public safety and to implement this section.

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