Brief Description: The Board of Pharmacy (Board) proposes to adopt regulation changes in Title 12, Chapter 52 of the Alaska Administrative Code, dealing with pharmacy technicians, collaborative practice authorities, sterile pharmaceutical guidelines, manufacturer license requirements, PDMP registration, alternative to probation program, and definitions, including the following:

1. 12 AAC 52.235. Pharmacy technician with national certification, is proposed to be updated to allow pharmacy technicians with a national certification to perform a final check of and distribute a non-controlled substance prescription if the pharmacy uses software that displays the image or graphical description of the correct drug being verified or the institutional facility uses software that performs and verifies a barcode scan before administration. Language that required a pharmacist to review and dispense an order due to deviation between the image or graphical depiction and the actual product being distributed is proposed for repeal.
2. 12 AAC 52.240. Pharmacist collaborative practice authority, is proposed to be amended to remove the requirement for Board approval of collaborative practice agreements, proposes repeal of the authorization for the board to require additional training if the board is not satisfied that the pharmacist has been adequately trained in the subject of a written protocol, and clarifies that the written protocol only be submitted for board awareness.
3. 12 AAC 52.430. Guidelines relating to sterile pharmaceuticals, is proposed to remove the Sterile Pharmaceuticals pamphlet that is currently adopted by reference and replace this with the acceptable standard of care defined in 12 AAC 52.995(a).
4. 12 AAC 52.698. Manufacturer license, is proposed to add the requirement of the most recent Good Manufacturing Practice inspection by the United States Food and Drug Administration (FDA). This will bring the regulations into alignment with outsourcing facilities regulations.
5. 12 AAC 52.855. Registration with the prescription drug monitoring program, is proposed to be updated to clarify the language outlining when registration with the Prescription Drug Monitoring Program (PDMP) controlled substance database is required.
6. 12 AAC 52.930. Terms of probation, proposes a technical change to an obsolete expression.
7. 12 AAC 52.940. Use of alcohol or controlled substances, proposes technical changes and is proposed to allow the board to grant non-punitive alternatives to probation for licensees that self-refer for addiction treatment.
8. 12 AAC 52.995. Definitions, is proposed to add definitions for the terms "owner" and "change of ownership", and clarify that written protocols no longer to be approved by the board.

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/215641, and using the comment link. The comments must be received not later than 4:30 p.m. on July 8, 2024.

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 July 1, 2024 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-0324.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.

Statutory Authority: AS 08.01.075; AS 08.80.005; AS 08.80.030; AS 08.80.157; AS 08.80.159; AS 08.80.168; AS 08.80.261; AS 08.80.480; AS 11.71.900; AS 17.30.200; AS 17.30.900
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.01.075; AS 08.80.005; AS 08.80.030; AS 08.80.157; AS 08.80.159; AS 08.80.261; AS 08.80.480; AS 17.30.200

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: 6/6/2024
Stefanie Davis, Regulations Specialist
Division of Corporations, Business and Professional Licensing

ADDITIONAL REGULATION NOTICE INFORMATION
(AS 44.62.190(d))

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

2.   General subject of regulation: Pharmacy technicians, collaborative practice authorities, sterile pharmaceutical guidelines, manufacturer license requirements, PDMP registration, alternative to probation program, and definitions.

3.   Citation of regulation: 12 AAC 52.235 through 12 AAC 52.995

4.   Department of Law file number: 2024200135.

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: 6/6/2024
        Prepared by: Stefanie Davis, Regulations Specialist