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ARIZONA STATE SENATE
Fifty-Fourth Legislature, Second Regular Session
automated prescription-dispensing kiosks; permits
Purpose
Establishes permit
application and label requirements for automated
prescription-dispensing kiosks.
Background
The Arizona State Board of Pharmacy (Board) regulates the practice of pharmacy and the distribution, sale and storage of prescription medications, prescriptive devices and nonprescription medications (A.R.S. § 32-1904).
Subject to approval by the Board, a person who holds a permit to operate a pharmacy, drug manufacturing facility or wholesaling facility may apply to the Board for a permit to operate an automated prescription-dispensing kiosk. An automated prescription-dispensing kiosk permit applies to a single automated prescription-dispensing kiosk; therefore, the person must obtain a separate permit for each to be operated. Additionally, the person must establish policies and procedures to ensure appropriate performance and use of the automated prescription-dispensing kiosk. An automated prescription-dispensing kiosk may not: 1) contain or dispense controlled substances; or 2) be placed in a gas station or convenience store (A.R.S. §§ 32-1929 and 32-1930; A.A.C. R4-23-677).
To renew an automated prescription-dispensing kiosk permit, a person must submit a completed permit renewal application electronically or manually on a form furnished by the Board with a $480 biennial renewal fee (A.A.C. R4-23-205 and R4-23-602).
An automated
prescription-dispensing kiosk is a mechanical system that: 1) is operated
as an extension of a pharmacy; 2) maintains all transaction information within
the pharmacy operating system; and 3) is separately permitted from the
pharmacy. The automated
prescription-dispensing kiosk performs operations that either: 1) accept a
prescription or refill order, store prepackaged or repackaged medications,
label and dispense patient-specific prescriptions and provide counseling on new
or refilled prescriptions; or 2) dispense or deliver a prescription or refill
that has been prepared by or on behalf of the pharmacy that oversees the
automated prescription-dispensing kiosk (A.R.S.
§ 32-1901).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1.
Requires a person to apply to the Board for a permit to operate an
automated
prescription-dispensing kiosk by submitting an application on a form prescribed
by the Board.
2. Requires a separate application and permit for each automated prescription-dispensing kiosk.
3. Requires a pharmacy to:
a) operate an automated prescription-dispensing kiosk as an extension of the pharmacy; and
b) remain responsible for inventory control and billing for kiosk-dispensed medications.
4. Requires, as part of an initial automated prescription-dispensing kiosk permit application, an agreement between the applicant and the tenant of the intended location of the kiosk to demonstrate intent to place the kiosk there, and requires the agreement to clearly indicate intent in the application through:
a) a letter of intent between the two parties;
b) an electronic communication between the two parties; or
c) a formal letter of agreement between the two parties.
5.
Requires a label on the container of a prescription filled by an
automated
prescription-dispensing kiosk to identify the address of the pharmacy
responsible for the kiosk.
6. Allows an automated prescription-dispensing kiosk's location to be provided:
a) on a prescription container label; or
b) in patient materials provided with the dispensed medication.
7. Specifies that the prescribed agreement information is not required in the Board's approval process of an automated prescription-dispensing kiosk permit application for a kiosk approved before August 3, 2018.
8. Requires an automated prescription-dispensing kiosk permittee to comply with automated prescription-dispensing kiosk requirements.
9. Requires the Board to:
a) use all applicable documents previously submitted to the Board at the time in which the automated prescription-dispensing kiosk was previously approved for the permit application process; and
b) issue a permit to any automated prescription-dispensing kiosk approved by the Board before August 3, 2018, that has submitted a permit application with the required fees.
10. Becomes effective on the general effective date.
Prepared by Senate Research
February 17, 2020
CRS/AB/kja