The bill SB1234 amends Arizona Revised Statutes and adds new provisions relating to the Arizona State Board of Pharmacy, specifically addressing the requirements for virtual manufacturers of prescription drugs or devices. The bill defines a "virtual manufacturer" as an entity that contracts for the manufacture of a drug or device but does not physically manufacture it themselves. Instead, they must own the relevant FDA application numbers for the drug or device and contract with an FDA-registered manufacturing entity for its physical manufacture.

The bill requires virtual manufacturers located in Arizona or responsible for shipping prescription drugs or devices into Arizona to make reasonable efforts to ensure that their contracted manufacturers comply with Current Good Manufacturing Practice (CGMP) regulations. Additionally, virtual manufacturers of prescription drugs must contract with a physical drug manufacturer that is permitted by the State of Arizona. This includes ensuring compliance with CGMP even if the contracted manufacturer is located in another country. The bill also includes conforming changes and becomes effective on the general effective date.

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