SB 1234
Initials DC/RP Page 1 House Engrossed
ARIZONA HOUSE OF REPRESENTATIVES
Fifty-sixth Legislature
Second Regular Session
Senate: HHS DP 7-0-0-0 | 3rd Read 25-2-3-0
House: RA DPA 5-1-0-1
SB 1234: pharmacy board; virtual manufacturers
Sponsor: Senator Shamp, LD 29
House Engrossed
Overview
Prescribes requirements for virtual manufacturers to comply with Current Good
Manufacturing Practice (CGMP) regulations and includes applicable requirements for when
a contracted manufacturer is in another country.
History
The United States Food and Drug A dministration monitors drug manufacturers for
compliance CGMP regulations to ensure the quality of drug products. CGMP regulations
consist of minimum requirements for the methods, facilities and controls for the
manufacturing, processing and packaging of drug products. For a new and generic drug to
enter the market, the FDA must determine whether the manufacturer complies with CGMP
regulations (CGMP).
Virtual manufacturers are required to ensure that the facility is inspected when an initial or
renewal application for determining the contracted manufacturer's CGMP compliance if the
manufacturer is in another country. Virtual manufacturer includes own-label distributors
that contract with a manufacturer to produce a drug or device and with another entity to
package and label the drug or device, which then is sold under the name of the distributor or
another name (A.A.C. R4-23-110)
The State Board of Pharmacy (Board) regulates the practice of pharmacy to protect the health
safety and welfare of Arizona citizens. The Board is authorized to issue specified permits in
the field of pharmacy which include: 1) a pharmacy permit; 2) a drug manufacturer's permit;
3) a drug packager or drug prepackager permit; and 4) a durable medical equipment or
compressed medical gas distributor or supplier permit. The Board is tasked with prescribing
and furnishing the requirements for a pharmacy permit application. Statute outlines the
grounds for the denial or revocation of a pharmacy permit by the Board (A.R.S. §§ 32-1929,
32-1930).
Provisions
1. Defines virtual manufacturer as an entity that:
a) contracts for the manufacture of a device including private label distributors;
b) owns either the FDA new drug application or abbreviated drug application number
for a drug or the unique FDA device identification number for a prescription device;
c) does not physically manufacture the drug or device; and
d) contracts with an FDA registered manufacturer for the physical manufacture of the
drug or device. (Sec. 1)
☐ Prop 105 (45 votes) ☐ Prop 108 (40 votes) ☐ Emergency (40 votes) ☐ Fiscal Note SB 1234
Initials DC/RP Page 2 House Engrossed
2. Requires a virtual manufacturer located in Arizona or any other jurisdiction, that is
responsible for the shipment of prescription drugs or devices into Arizona, to make
professionally reasonable efforts to ensure that the FDA registered manufacturing entity
complies with applicable CGMP regulations. (Sec. 2)
3. Directs virtual manufacturers of prescription drugs to contract with a permitted drug
manufacturer in Arizona. (Sec. 2)
4. Makes conforming changes. (Sec. 1)