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NOTICE OF PROPOSED CHANGES IN THE REGULATIONS OF THE ALASKA BOARD OF PHARMACY

Brief Description: The Board of Pharmacy proposes to update various regulations relating to licensure, registration, change of pharmacy location, name or ownership, licensure by examination, internship requirements, examination, intern license, out-of-state pharmacy registration, pharmacy technicians, pharmacist-in-charge, cooperative practice agreement, refills, patient counseling, wholesale drug distributor license, facilities, facility manager, definitions, prescription drug monitoring program, and display of license certificate. 

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 52.020. Pharmacy license, is proposed to amend the pharmacy licensure requirements.
  2. 12 AAC 52.030. Change of pharmacy location or name, is proposed to be repealed; requirements amended and incorporated in 12 AAC 52.020.
  3. 12 AAC 52.040. Change of pharmacy ownership, is proposed to be repealed; requirements amended and incorporated in 12 AAC 52.020.
  4. 12 AAC 52.070. Application for pharmacist license by examination, is proposed to amend and streamline the application process for pharmacist licensure by examination.
  5. 12 AAC 52.080. Internship requirements for a pharmacist license, is proposed to be repealed.
  6. 12 AAC 52.092. Eligibility to sit for examination, is proposed to amend and streamline the exam eligibility process.
  7. 12 AAC 52.095. Application for pharmacist license by reciprocity, is proposed to amend and streamline the application process for pharmacist licensure by reciprocity.
  8. 12 AAC 52.120. Review of pharmacist intern license application, is proposed to amend and streamline the pharmacist intern license application requirements.
  9. 12 AAC 52.130. Registration of pharmacies located outside of the state, is proposed to amend and streamline the requirements for out-of-state pharmacy registration.
  10. 12 AAC 52.140. Pharmacy technician license, is proposed to amend the pharmacy technician license application requirements.
  11. 12 AAC 52.200. Pharmacist-in-charge, is proposed to update the pharmacist-in-charge duties and guidelines.
  12. 12 AAC 52.230. Pharmacy technicians, is proposed to update the functions of pharmacy technicians.
  13. 12 AAC 52.240. Pharmacist cooperative practice authority, is proposed to update and streamline the pharmacist cooperative practice agreement process.
  14. 12 AAC 52.470. Refills, is proposed to remove unnecessary language.
  15. 12 AAC 52.585. Patient counseling, is proposed to update and clarify the patient counseling process.
  16. 12 AAC 52.610. Wholesale drug distributor license, is proposed to amend and streamline the wholesale drug distributor license application process.
  17. 12 AAC 52.620. Wholesale drug facilities, is proposed to include devices to the wholesale drug facilities regulations.
  18. 12 AAC 52.635. Facility manager, is a proposed new section that establishes standards for a facility manager of a wholesale drug distributor, outsourcing facility, or third-party logistics providers.
  19. 12 AAC 52.696. Outsourcing facilities, is proposed to amend and streamline the outsourcing facilities application requirements.
  20. 12 AAC 52.697. Third-party logistics providers, is proposed to amend and streamline the third-party logistics providers application requirements.
  21. 12 AAC 52.860. Access to and conditions for use of the prescription drug monitoring program database, is proposed to add a definition for “state medical examiner”.
  22. 12 AAC 52.865. Reporting and reviewing PDMP information, is proposed to update the reporting and reviewing of PDMP information.
  23. 12 AAC 52.990. Display of license certificate, is proposed to remove outdated language.

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/206712, and using the comment link. The comments must be received not later than 4:30 p.m. on June 13, 2022. 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 June 6, 2022 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-0522.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 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.145; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.160; AS 08.80.330; AS 08.80.480; AS 17.30.200
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.145; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.160; AS 08.80.330; AS 08.80.480; AS 17.30.200

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

DATE: 5/11/2022
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: Licensure, registration, change of pharmacy location, name or ownership, licensure by examination, internship requirements, examination, intern license, out-of-state pharmacy registration, pharmacy technicians, pharmacist-in-charge, cooperative practice agreement, refills, patient counseling, wholesale drug distributor license, facilities, facility manager, definitions, prescription drug monitoring program, and display of license certificate

3.   Citation of regulation: 12 AAC 52.020 through 12 AAC 52.990.

4.   Department of Law file number: To be assigned.

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 2022 or in subsequent years.

9.   The name of the contact person for the regulation:
    
Laura Carrillo, 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: laura.carrillo@alaska.gov

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

11.   Date: 5/11/2022
        Prepared by: Jun Maiquis
                            Regulations Specialist

Attachments, History, Details

Revision History

Created 5/11/2022 12:14:44 PM by jcmaiquis
Modified 5/11/2022 12:15:55 PM by jcmaiquis
Modified 5/12/2022 3:52:41 PM by jcmaiquis

Details

Department: Commerce, Community and Economic Development
Category: Regulations
Sub-Category: Notice of Proposed Regulations
Location(s): Statewide
Project/Regulation #:
 
Publish Date: 5/11/2022
Archive Date: 6/14/2022
 
Events/Deadlines:
  • Comments Deadline
    6/13/2022 4:30pm