Brief Description:  The Board of Pharmacy proposes to update various regulations relating to the practice of pharmacy under the authority of AS 08.80 and 12 AAC 52.  The proposed regulations deal with a wide range of subjects, including new licensing categories, closed pharmacies, licensure requirements, temporary license, permits, pharmacist intern license application, licensure for individual pharmacists working for tribal health program, pharmacist interns, pharmacist collaborative practice authority, approved programs, remote pharmacy license, telepharmacy system, controlled substance prescription drug orders, refills, transfer of a prescription drug order, substitution, return or exchange of drugs, wholesale drug distributor license, facilities, personnel, drug storage, disciplinary guidelines, grounds for denial or discipline for criminal history, emergency preparedness, executive administrator position, definition of terms, and to implement the statutory amendments made in AS 08.80 by Chapter 66 SLA 2018 (SB 37) and Chapter 58 SLA 2018 (SB 32).

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 be changed to add new licensing categories including third-party logistics providers, outsourcing facilities, and out-of-state wholesale drug distributors.

2. 12 AAC 52.050. Closed pharmacies, is proposed to be changed to amend the requirement that when a pharmacy closes its business it must submit a form provided by the department.   

3. 12 AAC 52.070. Application for pharmacist license by examination, is proposed to be changed to amend the checklist requirements for pharmacist license by examination application.

4. 12 AAC 52.095. Application for pharmacist license by reciprocity, is proposed to be changed to amend the checklist requirements for pharmacist license by reciprocity application.

5. 12 AAC 52.105. Temporary license for military personnel or the spouse of active duty military personnel, is a proposed new section for temporary license application for military personnel or spouses of active duty military personnel. 

6. 12 AAC 52.110. Emergency pharmacist permit, is proposed to be changed to repeal the need to take the state jurisprudence examination.

7. 12 AAC 52.120. Review of pharmacist intern license application, is proposed to be changed to repeal the need to obtain sponsorship and add a new regulation that intern licenses supersede pharmacy technician licenses.

8. 12 AAC 52.150. Proof of licensure for individual pharmacists working for tribal health program, is proposed to add new regulations around out of state licensed pharmacists providing proof of licensure when working for tribal health programs in this state.

9. 12 AAC 52.220. Pharmacist interns, is proposed to amend the regulation that a pharmacist intern may perform any duties of a pharmacy technician.

10. 12 AAC 52.240. Pharmacist collaborative practice authority, is proposed to be changed to add that they can’t result in a pharmacist dispensing or administering any schedule I, II, III, or IV controlled substance and acknowledging that the authorizing practitioner will not receive any compensation from a pharmacist or pharmacy as a result of the care or treatment of any patient under the agreement.

11. 12 AAC 52.340. Approved programs, is proposed to be changed to clarify the type of ACPE program certificates that are approved for continuing education.

12. 12 AAC 52.423. Remote pharmacy license, is proposed to be changed to remove the distance requirement for renewals.

13. 12 AAC 52.425. Telepharmacy system for a remote pharmacy, is proposed to be changed to amend employment requirements, shipping drugs to a remote pharmacy from the central pharmacy or wholesale distributor, maintaining records requirements, labelling requirements, and repealing the pharmacist-in-charge of the central pharmacy maintaining compliance.

14. 12 AAC 52.465. Controlled substance prescription drug orders, is a proposed new section to allow partial filling of schedule II controlled substances.

15. 12 AAC 52.470. Refills, is proposed to be changed to amend the ability to dispense up to a 100-day supply and can dispense any quantity with conditions.

16. 12 AAC 52.500. Transfer of a prescription drug order, is proposed to be amended to remove refills from what is allowed.

17. 12 AAC 52.510. Substitution, is proposed to be changed to add interchangeable biological products and repeal the requirement to dispense a less costly equivalent drug product over the prescribed.

18. 12 AAC 52.530. Return or exchange of drugs, is proposed to be changed to amend the ability of a patient to return medication to a pharmacy if it was filled incorrectly or was recalled by the manufacturer or FDA.

19. 12 AAC 52.610. Wholesale drug distributor license, is proposed to be changed to amend the checklist requirements for wholesale drug distributor license application.

20. 12 AAC 52.620. Wholesale drug facilities, is proposed to add the requirements that a wholesale drug distributor facility seeking to ship into or distribute prescription drugs in this state must verify that the purchaser of the prescription drugs holds a valid license under AS 08.

21. 12 AAC 52.625. Personnel requirements; grounds for denial or other disciplinary action, is proposed to be changed to introduce the manager position as a facility manager.

22. 12 AAC 52.630. Drug storage, is proposed to be changed to amend temperature requirements be maintained to label requirements, and remove the reference to United States Pharmacopoeia (USP). 

23. 12 AAC 52.640 – 12 AAC 52.695, proposed changes are to amend the authority citations to include out-of-state wholesale drug distributors.

24. 12 AAC 52.696. Outsourcing facilities, is a proposed new section that establishes requirements for an outsourcing facility license.

25. 12 AAC 52.697. Third-party logistics providers, is a proposed new section that establishes requirements for a third-party logistics providers license.

26. 12 AAC 52.920. Disciplinary guidelines, is proposed to be changed to add sexual orientation or gender identity discrimination as a basis for potential disciplinary action and add civil fines associated with failure to meet continuing education requirements.

27. 12 AAC 52.925. Grounds for denial or discipline for criminal history, is a proposed new section that establishes grounds for denying or disciplining a licensee under the ability to practice competently and safely.

28. 12 AAC 52.985. Emergency preparedness, is proposed to add new regulations regarding emergency preparedness and what pharmacies can dispense under emergencies declared by the governor.

29. 12 AAC 52.993. Executive administrator, is proposed to add new regulations regarding the executive administrator position.

30. 12 AAC 52.995. Definitions, is proposed to add a new definition for “facility manager” and “moral turpitude”.

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/193975, and using the comment link. The comments must be received not later than 4:30 p.m. on May 24, 2019. 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 May 17, 2019 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-0419.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 08.01.064; AS 08.01.075; AS 08.80.003; AS 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.145; AS 08.80.150; AS 08.80.155; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.261; AS 08.80.270; AS 08.80.295; AS 08.80.315; AS 08.80.330; AS 08.80.345; AS 08.80.390; AS 08.80.410; 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 08.01.064; AS 08.01.075; AS 08.80.003; AS 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.145; AS 08.80.150; AS 08.80.155; AS 08.80.157; AS 08.80.158; AS 08.80.159; AS 08.80.261; AS 08.80.270; AS 08.80.295; AS 08.80.315; AS 08.80.330; AS 08.80.345; AS 08.80.390; AS 08.80.410; AS 08.80.460; 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: 4/24/19
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:  Licensing and registration requirements, permit, personnel, approved programs, guidelines for pharmacies and pharmacists, pharmacy practice standards, wholesale drug distributors and facilities, disciplinary guidelines, emergency preparedness, executive administrator, and definitions.

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

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

5.   Reason for the proposed action:  Update and clarification of current regulations; compliance with new state statutes – Chapter 66 SLA 2018 (SB 37) and Chapter 58 SLA 2018 (SB 32).

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

7.   Estimated annual cost to comply with the proposed action to:
      A private person:  $100 initial application, $600 initial biennial license, and $600 biennial license renewal fees for third-party logistics provider, outsourcing facility, and non-resident wholesale drug distributor.
      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 2019 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: 4/24/19
        Prepared by: Jun Maiquis
        Regulations Specialist 
        (907) 465-2537