The bill SB1234 amends existing Arizona law to establish specific requirements for virtual manufacturers of prescription drugs and devices. It defines a "virtual manufacturer" as an entity that contracts for the manufacture of a drug or device, including private label distributors, and outlines the conditions they must meet, such as owning the relevant FDA application numbers and not being involved in the physical manufacturing process. Additionally, the bill mandates that virtual manufacturers ensure their contracted physical manufacturers comply with current Good Manufacturing Practices (CGMP) and that they must contract with drug manufacturers permitted by the state of Arizona.

Key changes from current law include the explicit definition of "virtual manufacturer," the requirement for these manufacturers to make reasonable efforts to ensure compliance with CGMP regulations, and the stipulation that they must contract with Arizona-permitted manufacturers regardless of the location of the contracted manufacturer. This legislation aims to enhance regulatory oversight and ensure the safety and quality of prescription drugs and devices produced under such arrangements.

Statutes affected:
Introduced Version: 32-1901, 32-1980, 13-3401, 32-1965, 32-1967, 32-1923, 32-1970, 32-1974, 36-2151, 32-1962, 32-1964, 36-416, 36-422
Senate Engrossed Version: 32-1901, 32-1980, 13-3401, 32-1965, 32-1967, 32-1923, 32-1970, 32-1974, 36-2151, 32-1962, 32-1964, 36-416, 36-422
House Engrossed Version: 32-1901, 32-1980, 13-3401, 32-1965, 32-1967, 32-1923, 32-1970, 32-1974, 36-2151, 32-1962, 32-1964, 36-416, 36-422
Chaptered Version: 32-1901, 32-1980, 13-3401, 32-1965, 32-1967, 32-1923, 32-1970, 32-1974, 36-2151, 32-1962, 32-1964, 36-416, 36-422