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ARIZONA STATE SENATE
Fifty-Sixth Legislature, Second Regular Session
AMENDED
pharmacy board; virtual manufacturers
Purpose
Outlines requirements for a virtual manufacturer of prescription drugs or devices when contracting with a physical manufacturer and defines the term virtual manufacturer.
Background
The U.S. Food and Drug Administration (FDA) regulates the quality of drug products by monitoring drug manufacturers' compliance with Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packaging a drug product. The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA assessors and investigators determine whether an applicant has the necessary facilities, equipment and ability to manufacture the drug it intends to market (FDA).
Virtual manufacturer means an entity that contracts for the manufacture of a drug or device for which the entity: 1) owns the new drug application or abbreviated new drug application number, as defined by the FDA, for a drug; 2) owns the unique device identification number, as defined by the FDA, for a prescription device; 3) is not involved in the physical manufacture of the drug or device; and 4) contracts with an Arizona-permitted manufacturing entity for the physical manufacture of the drug or device. If the contracted manufacturing entity is located in a different country, the virtual manufacturer must ensure the facility is inspected every time the virtual manufacturer submits an initial or renewal application and determine the contracted manufacturing entity complies with CGMP regulations. Virtual manufacturer includes an entity that may be identified as an own-label distributor, which contracts with a manufacturer to produce a drug or device and with another entity to package and label the drug or device (A.A.C. R4-23-110).
The Joint Legislative Budget Committee (JLBC) fiscal note on S.B.1234 estimates that the bill would reduce permit revenues collected by the Board of Pharmacy (Board), of which 10 percent is deposited into the state General Fund (state GF). As a result, there may be an impact to the state GF if permit revenues collected by the Board decrease (JLBC).
Provisions
1. Requires a virtual manufacturer located in Arizona, or that is responsible for shipping prescription drugs or devices into Arizona, to make reasonable efforts to ensure that the contracted, physical manufacturer of the prescription drug or device complies with CGMP regulations.
2. Requires a virtual manufacturer of prescription drugs to contract with a physical drug manufacturer that is permitted by the State of Arizona.
3. Defines virtual manufacturer as an entity that contracts for the manufacture of a drug or device, including a private label distributor, and that meets the following conditions:
a) owns either the new drug application or abbreviated drug application number assigned by the FDA for a drug or the unique identification number assigned by the FDA for a prescription device;
b) is not involved with the physical manufacture of the drug or device; and
c) contracts with a manufacturing entity that is registered with the FDA for the physical manufacture of the drug or device.
4) Makes conforming changes.
5) Becomes effective on the general effective date.
Amendments Adopted by the House of Representatives
· Requires a virtual manufacturer of prescription drugs to contract with a physical drug manufacturer that is permitted by the State of Arizona, regardless of whether the contracted manufacturer is located in another country.
Senate Action House Action
HHS 2/6/24 DP 7-0-0 RA 3/13/24 DPA 5-1-0-1
3rd Read 2/29/24 25-2-3 3rd Read 4/3/24 28-31-0-0-1
3rd Read* 6/15/24 35-22-3
*On reconsideration
Prepared by Senate Research
June 15, 2024
MM/KS/slp