Brief Description: The Board of Pharmacy proposes to update various regulations relating to classifications of licensure, registration, application, license and registration renewal, notification process for changes in name, ownership or physical address of pharmacies, pharmacist-in-charge, pharmacist interns, job shadowing, security, remote pharmacy, return or exchange of drugs, automated distribution kiosks, remodeling, designated representative, drug recalls, facilities, prescription drug monitoring program, and definitions. 

The Board of Pharmacy (Board) proposes to adopt regulation changes in Title 12, Chapter 52 of the Alaska Administrative Code including the following:

1. 12 AAC 52.010. Classifications of licensure, is proposed to add manufacturer to the licensing categories.
2. 12 AAC 52.020. Pharmacy license, is proposed to amend the notification process for changes in name, ownership, or physical address of pharmacies; and to remove redundant requirements.
3. 12 AAC 52.120. Review of pharmacist intern license application, is proposed to provide pharmacy interns the opportunity to relinquish their pharmacy technician licenses without penalty.
4. 12 AAC 52.200. Pharmacist-in-charge, is proposed to extend the notification of change requirement for a pharmacist-in-charge from 10 days to 30 days from the date of assignment; and remove outdated regulations.
5. 12 AAC 52.220. Pharmacist interns, is proposed to remove the requirement for pharmacist interns to submit a report of work experience 30 days following the completion or termination of an internship rotation.
6. 12 AAC 52.250. Job shadowing in pharmacy, is proposed to be repealed.
7. 12 AAC 52.300. License and registration renewal, is proposed to add manufacturer as a license type required to renew biennially on the date set by the board; and remove outdated regulations.
8. 12 AAC 52.420. Security, is proposed to allow automated distribution kiosks to be kept outside of the secured prescription area of a pharmacy.
9. 12 AAC 52.423. Remote pharmacy license, is proposed to amend the notification process for a remote pharmacy that has changed its name, physical address, or ownership.
10. 12 AAC 52.530. Return or exchange of drugs, is proposed to remove unnecessary language.
11. 12 AAC 52.595. Automated distribution kiosks, is a proposed new section that allows a licensed pharmacy in this state to install and use automated distribution kiosks to be kept on the same premises as the pharmacy.
12. 12 AAC 52.596. Remodeling, is a proposed new section establishing a streamlined notification process during a structural remodeling of premises occupied by a licensed or registered pharmacy.
13. 12 AAC 52.610. Wholesale drug distributor license, is proposed to amend the term “facility manager” to “designated representative” to align with the national industry standard; and to update the notification process for changes in name, ownership, or physical address of pharmacies.
14. 12 AAC 52.625. Personnel requirements; grounds for denial or other disciplinary action, is proposed to amend the term “facility manger” to “designated representative” to align with the national industry standard.
15. 12 AAC 52.635. Designated representative, is proposed to amend the term “facility manager” to “designated representative” to align with the national industry standard.
16. 12 AAC 52.640. Written policies and procedures, is proposed to be changed to conform with the repeal of section 12 AAC 52.670.
17. 12 AAC 52.670. Drug recalls, is proposed to be repealed.
18. 12 AAC 52.696. Outsourcing facilities, is proposed to amend the term “facility manager” to “designated representative” to align with the national industry standard; and update the notification process for changes in name, ownership, or physical address of pharmacies.
19. 12 AAC 52.697. Third-party logistics providers, is proposed to amend the term “facility manager” to “designated representative” to align with the national industry standard; and update the notification process for changes in name, ownership, or physical address of pharmacies.
20. 12 AAC 52.698. Manufacturer license, is a proposed new section that establishes manufacturer licensure requirements.
21. 12 AAC 52.800. Drug room license, is proposed to amend the notification process of changes in name, ownership, or physical address of pharmacies.
22. 12 AAC 52.855. Registration with the prescription drug monitoring program, is proposed to amend the requirement for a non-dispensing pharmacist to submit a dispensation exemption form at time of licensure.
23. 12 AAC 52.860. Access to and conditions for use of the prescription drug monitoring program, is proposed to remove the term “database” from the section heading title.
24. 12 AAC 52.995. Definitions, is proposed to further define terms used in 12 AAC 52.

You may comment on the proposed regulation changes, including the potential costs to private persons of complying with the proposed changes, by submitting written comments to Jun Maiquis, Regulations Specialist, Division of Corporations, Business and Professional Licensing, P.O. Box 110806, Juneau, AK  99811-0806. Additionally, the Board will accept comments by facsimile at (907) 465-2974 and by electronic mail at RegulationsAndPublicComment@alaska.gov. Comments may also be submitted through the Alaska Online Public Notice System by accessing this notice on the system at http://notice.alaska.gov/210412, and using the comment link. The comments must be received not later than 4:30 p.m. on April 24, 2023. Comments received after this deadline will not be considered by the Board.

You may submit written questions relevant to the proposed action to Jun Maiquis, Regulations Specialist, Division of Corporations, Business and Professional Licensing, P.O. Box 110806, Juneau, AK  99811-0806 or by e-mail at RegulationsAndPublicComment@alaska.gov. The questions must be received at least 10 days before the end of the public comment period. The Board will aggregate its response to substantially similar questions and make the questions and responses available on the Alaska Online Public Notice System and on the Board’s website at https://www.commerce.alaska.gov/web/cbpl/ProfessionalLicensing/BoardofPharmacy.aspx. The Board may, but is not required to, answer written questions received after the 10-day cut-off date and before the end of the comment period.

If you are a person with a disability who needs a special accommodation in order to participate in this process, please contact Jun Maiquis at (907) 465-2537 or RegulationsAndPublicComment@alaska.gov not later than April 17, 2023 to ensure that any necessary accommodation can be provided.

A copy of the proposed regulation changes is available on the Alaska Online Public Notice System and by contacting Jun Maiquis at (907) 465-2537 or RegulationsAndPublicComment@alaska.gov, or go to https://www.commerce.alaska.gov/web/portals/5/pub/PHA-2023200061.pdf.

After the public comment period ends, the Board will either adopt the proposed regulation changes or other provisions dealing with the same subject, without further notice, or decide to take no action. The language of the final regulation may be different from that of the proposed regulation. You should comment during the time allowed if your interests could be affected. Written comments and questions received are public records and are subject to public inspection.

Statutory Authority: AS 08.01.100; AS 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.147; AS 08.80.150; AS 08.80.155; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.160; AS 08.80.165; AS 08.80.261; AS 08.80.270; AS 08.80.315; AS 08.80.330; AS 08.80.390; AS 08.80.410; AS 08.80.480; AS 11.71.900; AS 17.30.200; AS 17.30.900
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.01.100; AS 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.147; AS 08.80.150; AS 08.80.155; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.160; AS 08.80.165; AS 08.80.261; AS 08.80.270; AS 08.80.315; AS 08.80.330; AS 08.80.390; AS 08.80.410; AS 08.80.480; AS 11.71.900; AS 17.30.200; AS 17.30.900

Fiscal Information: The proposed regulation changes are not expected to require an increased appropriation.

DATE: 3/22/2023
Jun Maiquis, Regulations Specialist
Division of Corporations, Business and Professional Licensing

For each occupation regulated under the Division of Corporations, Business and Professional Licensing, the Division keeps a list of individuals or organizations who are interested in the regulations of that occupation. The Division automatically sends a Notice of Proposed Regulations to the parties on the appropriate list each time there is a proposed change in an occupation's regulations in Title 12 of the Alaska Administrative Code. If you would like your address added to or removed from such a list, send your request to the Division at the address above, giving your name, either your e-mail address or mailing address (as you prefer for receiving notices), and the occupational area in which you are interested.

ADDITIONAL REGULATION NOTICE INFORMATION
(AS 44.62.190(d))

1.   Adopting agency: Board of Pharmacy – Department of Commerce, Community, and Economic Development, Division of Corporations, Business and Professional Licensing.

2.   General subject of regulation: Classifications of licensure, pharmacy license, registration, notification process for changes in name, ownership or physical address of pharmacies, intern license, application, licensure, pharmacist-in-charge, pharmacist interns, job shadowing, security, remote pharmacy, return or exchange of drugs, automated distribution kiosks, remodeling, designated representative, drug recalls, facilities, prescription drug monitoring program, and definitions.

3.   Citation of regulation: 12 AAC 52.010 through 12 AAC 52.995.

4.   Department of Law file number: 2023200061.

5.   Reason for the proposed action: Update and clarification of current regulations; compliance with state statute.

6.   Appropriation/Allocation: Corporations, Business and Professional Licensing – #2360.

7.   Estimated annual cost to comply with the proposed action to:
     A private person: Fees for manufacturers license – $100 initial application; $550 initial biennial
        license; $550 biennial license renewal.
        Another state agency: None known.
        A municipality: None known.

8.   Cost of implementation to the state agency and available funding (in thousands of dollars):  No costs are expected in FY 2023 or in subsequent years.

9.   The name of the contact person for the regulation:
     Michael Bowles, Executive Administrator
         Alaska Board of Pharmacy
         Division of Corporations, Business and Professional Licensing
         Department of Commerce, Community, and Economic Development
         Telephone: (907) 269-8614
          E-mail: michael.bowles@alaska.gov

10.   The origin of the proposed action: Board of Pharmacy.

11.   Date: 3/22/2023
     Prepared by: Jun Maiquis
                             Regulations Specialist