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AZ SB1234
Bill
Status
6/21/2024
Primary Sponsor
Janae Shamp
Click for details
AI Summary
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Amends Arizona Revised Statutes section 32-1901 to add a definition of "virtual manufacturer" as an entity that contracts for drug or device manufacturing, owns the applicable FDA application or device identification number, is not involved in physical manufacturing, and contracts with an FDA-registered manufacturer.
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Removes language requiring the board to define virtual manufacturers in rule, instead codifying the definition directly in statute.
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Adds new section 32-1980 requiring virtual manufacturers located in Arizona or shipping prescription drugs or devices into Arizona to make professionally reasonable efforts to ensure their contracted FDA-registered manufacturers comply with current good manufacturing practices under federal regulations.
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Requires virtual manufacturers of prescription drugs to contract with a drug manufacturer that is permitted by Arizona.
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Became effective upon Governor's approval on June 21, 2024.
Legislative Description
Pharmacy board; virtual manufacturers
Definitions
Last Action
Chapter 234
6/21/2024