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AZ SB1234

Bill

Status

Passed

6/21/2024

Primary Sponsor

Janae Shamp

Click for details

Origin

Senate

Fifty-sixth Legislature - Second Regular Session (2024)

AI Summary

  • 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.

  • Removes language requiring the board to define virtual manufacturers in rule, instead codifying the definition directly in statute.

  • 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.

  • Requires virtual manufacturers of prescription drugs to contract with a drug manufacturer that is permitted by Arizona.

  • Became effective upon Governor's approval on June 21, 2024.

Legislative Description

Pharmacy board; virtual manufacturers

Definitions

Last Action

Chapter 234

6/21/2024

Committee Referrals

Rules3/4/2024
Regulatory Affairs2/29/2024
Rules1/29/2024
Health and Human Services1/29/2024

Full Bill Text

No bill text available