Brief Description: The Board of Pharmacy proposes to adopt regulation changes in Title 12, Chapter 52 of the Alaska Administrative Code, dealing with adding a retired status pharmacist license, and implementing additional statutory changes to AS 08.80 under Chapter 15, SLA 2023 (HB 112) including the following:

1. 12 AAC 52.010. Classifications of licensure, is proposed to be repealed to remove redundant language from the regulations.
2. 12 AAC 52.020. Pharmacy license, is proposed to amend the requirements to be in compliance with HB 112 to require out of state pharmacies to be licensed in Alaska, rather than registered, and to remove a statute reference that is being repealed by HB 112.
3. 12 AAC 52.070. Application for pharmacist license by examination, is proposed to amend the regulation to remove the requirement of two affidavits attesting to good moral character to be in compliance with HB 112.
4. 12 AAC 52.075. Good moral character, is proposed to be repealed to be in compliance with HB 112.
5. 12 AAC 52.095. Application for pharmacist license by reciprocity, is proposed to add clarifying language and amend the regulation to remove the requirement of two affidavits attesting to good moral character to be in compliance with HB 112.
6. 12 AAC 52.120. Review of pharmacist intern license application is proposed to clarify that pharmacist interns must apply for a new license, rather than reapply if expired.
7. 12 AAC 52.130. Registration of pharmacies located outside of the state, is repealed to be in compliance with HB 112 to require out of state pharmacies to be licensed in Alaska, rather than registered.
8. 12 AAC 52.140. Pharmacy technician license, is proposed to amend the requirements of pharmacy technicians to lower the age to become licensed from 18 to 16 years of age.
9. 12 AAC 52.200. Pharmacist-in-charge, is proposed to amend the requirements to be in compliance with HB 112 to require out of state pharmacies to be licensed in Alaska, rather than registered.
10. 12 AAC 52.205. General standards of pharmacy practice, is proposed to bring the regulations into alignment with standards of pharmacy practice throughout the United States of America.
11. 12 AAC 52.240. Pharmacist collaborative practice authority, is proposed to bring this section into alignment with the Mainstreaming Addiction Treatment Act of 2021 (MAT Act).
12. 12 AAC 52.245. Retired status pharmacist license, is proposed to be added to create a retired status pharmacist license, to be in compliance with HB 112.
13. 12 AAC 52.300. License and registration renewal, is proposed to amend the regulations to remove language referring to registration, per HB 112.
14. 12 AAC 52.310. Reinstatement of an expired pharmacist or pharmacy technician license, is proposed to clarify the difference between lapsed and expired licenses.
15. 12 AAC 52.423. Remote pharmacy license, is proposed to streamline language and requirements.
16. 12 AAC 52.500. Transfer of a prescription drug order, is proposed to amend the requirements to ensure compliance with 21 CFR 1306 (Code of Federal Regulations).
17. 12 AAC 52.800. Drug room license, is edited to remove a proposed repealed section.
18. 12 AAC 52.857. Change in dispensing or distributing of controlled substances, is proposed to amend the regulations to remove language referring to registration, per HB 112.
19. 12 AAC 52.865. Reporting and reviewing PDMP information, is proposed to clarify the regulation requirements to be in alignment with HB 56.
20. 12 AAC 52.920. Disciplinary guidelines, is proposed to clarify regulatory language and bring the language into alignment with the proposed addition of 12 AAC 52.205.
21. 12 AAC 52.991. Disciplinary decision or conviction reporting requirement, is proposed to bring the language into alignment with the standard of pharmacy practice throughout the United States of America to ensure all disciplinary action or criminal activity for all license types is disclosed to the board of pharmacy in a timely manner.
22. 12 AAC 52.992. Administration of vaccines, epinephrine, and related emergency medications, is proposed to amend the regulation to be in compliance with HB 112, as well as streamline guidelines.
23. 12 AAC 52.993. Executive administrator, is proposed to amend the regulations to remove language referring to registration, per HB 112.
24. 12 AAC 52.995. Definitions, is proposed to amend the regulations to define “Internet-based pharmacy”, as well as “standard of care” and “facility” per HB 112.

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 Stefanie Davis, 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/212938, and using the comment link. The comments must be received not later than 4:30 p.m. on November 16, 2023. Comments received after this deadline will not be considered by the Board.

You may submit written questions relevant to the proposed action to Stefanie Davis, 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.

If you are a person with a disability who needs a special accommodation in order to participate in this process, please contact Stefanie Davis at (907) 465-2537 or RegulationsAndPublicComment@alaska.gov not later than November 9, 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 Stefanie Davis at (907) 465-2537, RegulationsAndPublicComment@alaska.gov, or at https://www.commerce.alaska.gov/web/portals/5/pub/PHA-0823.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 08.01.075; 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 08.80.157; AS 08.80.159; AS 08.80.160; AS 08.80.165; AS 08.80.168; AS 08.80.261; AS 08.80.270; AS 08.80.315; AS 08.80.330; AS 08.80.460; AS 08.80.480; AS 11.71.900; AS 17.30.200; AS 17.30.900
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.80.030; AS 08.80.145; AS 08.80.157; AS 08.80.159; AS 08.80.160; AS 08.80.270
Fiscal Information: The proposed regulation changes are not expected to require an increased appropriation.

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.

DATE: 10/17/2023
Stefanie Davis, Regulations Specialist
Division of Corporations, Business and Professional Licensing

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: Update regulations to be in compliance with HB 112, general clarification of regulations.   

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

4.   Department of Law file number: 2023200336

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: None known.
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 2024 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) 465-1073
E-mail: Michael.Bowles@Alaska.Gov

10.   The origin of the proposed action: Staff of state agency.

11.   Date: 10/17/2023
    Prepared by: Stefanie Davis, Regulations Specialist