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FL S0512

Bill

Status

Failed

3/14/2020

Primary Sponsor

Rules

Click for details

Origin

Senate

2020 Regular Session

AI Summary

  • Creates new licensing and regulatory framework for nonembryonic stem cell banks, requiring them to register with and obtain permits from the Department of Business and Professional Regulation and obtain health care clinic licenses from the Agency for Health Care Administration.

  • Prohibits nonembryonic stem cell banks from performing enzymatic digestion, mechanical disruption, or similar processes that alter stem cell characteristics unless the establishment is registered with the FDA and complies with drug, device, or biological product manufacturing regulations.

  • Requires nonembryonic stem cell banks to employ a physician medical director with an active license, maintain minimum $250,000 liability insurance per claim, adhere to current good tissue and manufacturing practices, and notify the agency within 10 days of any medical director termination.

  • Restricts dispensing of adult human nonembryonic stem cells and compounded stem cell products to the manufacturing stem cell bank, pharmacists at licensed stem cell banks, and authorized physicians; prohibits other entities from selling or dispensing these products.

  • Requires physicians, advanced practice registered nurses, and physician assistants to only practice at nonembryonic stem cell banks licensed by the Agency for Health Care Administration, with violations subject to disciplinary action by regulatory boards.

Legislative Description

Nonembryonic Stem Cell Banks

Last Action

Died in Messages

3/14/2020

Committee Referrals

Rules2/21/2020
Appropriations2/10/2020
Health Policy11/1/2019

Full Bill Text

No bill text available