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CA AB1822
Bill
AI Summary
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Creates exemption from tissue bank licensing for hospitals and outpatient settings that store human cell, tissue, or cellular- or tissue-based products (HCT/P) obtained from state-licensed tissue banks.
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Requires HCT/P to be stored in original unopened enclosure in strict accordance with manufacturer instructions and intended solely for direct implantation or application on patients, with no further distribution.
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Mandates HCT/P must be regulated by the FDA under Parts 1270 and 1271 of Title 21 of the Code of Federal Regulations to qualify for the exemption.
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Maintains existing exemptions for physician/podiatrist storage and other tissue bank activities including blood banks, research tissue, and organ procurement organizations.
Legislative Description
Tissue banks.
Last Action
Vetoed by Governor.
9/25/2014