Brief Description:  The Board of Pharmacy proposes to make permanent regulation changes made by emergency regulation relating to the practice of pharmacy under the authority of AS 08.80 and 12 AAC 52, including pharmacist duties, pharmacy interns, pharmacy technicians, pharmacy technician with national certification, license renewal, shared pharmacy services during emergency, refills, labeling, prescriptions by electronic transmission, transfer of a prescription drug order, substitution, emergency preparedness, independent administration of vaccines and related emergency medications, and definitions.

On March 27, 2020, the Board of Pharmacy (Board) adopted, as an emergency regulation, changes in Title 12, Chapter 52, of the Alaska Administrative Code including the following:

1. 12 AAC 52.060. Fire or other disaster, is proposed to establish a definition for “other disaster”; to include any disaster which causes a pharmacy to move to a temporary location or results in damage to the drug or device inventory.
2. 12 AAC 52.210. Pharmacist duties, is proposed to add receiving an oral prescription drug order from a practitioner or authorized agent of a practitioner, and to also add administer a prescription drug order in accordance with the prescriber’s order.
3. 12 AAC 52.220. Pharmacist interns, is proposed to remove the requirement to physically review prescription drug orders and dispensed products before distributing to a patient or the patient’s agent.
4. 12 AAC 52.230. Pharmacy technicians, is proposed to remove cashier or bookkeeper from having to obtain a license as a pharmacy technician.
5. 12 AAC 52.235. Pharmacy technician with national certification, is a proposed new section that provides additional scope to pharmacy technicians who holds a national certification; allows them to perform final checks on non-controlled substance prescriptions, transfer non-controlled substance prescription orders, clarify or obtain missing information from practitioner for non-controlled substance prescriptions.
6. 12 AAC 52.300. License renewal, is proposed to remove the requirement to submit documentation of continuing education and accept attestation of completing said continuing education requirements, to suspend CPR certification requirements, and to remove the jurisprudence questionnaire requirement for renewal.
7. 12 AAC 52.446. Shared pharmacy services during emergency, is a proposed new section that establishes shared pharmacy services during an emergency; it suspends the existing shared pharmacy regulations in 12 AAC 52.445 only during the duration of an emergency; allows a pharmacist intern and pharmacy technician to engage in shared pharmacy services; removes requirements for shared pharmacy services to be approved by the board.
8. 12 AAC 52.470. Refills, is proposed to amend the provisions related to refills, including the ability to dispense up to a 120-day supply.
9. 12 AAC 52.480. Labeling, is proposed to clarify that initials may be handwritten on the prescription label.
10. 12 AAC 52.490. Prescriptions by electronic transmission, is proposed to clarify that prescriptions for devices may be transmitted electronically.
11. 12 AAC 52.500. Transfer of a prescription drug order, is proposed to allow pharmacist interns and pharmacy technicians who holds a national certification to engage in the transfer of a prescription drug order; specifies what conditions must be met in order to engage in related activities.
12. 12 AAC 52.510. Substitution, is proposed to clarify that a prescriber can indicate on the prescription whether a substitution for an equivalent drug interchangeable can be dispensed; provides for a patient to request the original drug product provided the prescriber has not indicated this cannot be provided.
13. 12 AAC 52.985. Emergency preparedness, is proposed to amend the provisions related to emergency preparedness; removes section on supply day and refills; waives notary requirements for application.
14. 12 AAC 52.992. Independent administration of vaccines and related emergency medications, is proposed to add pharmacist interns to require them to offer current vaccine information statements for administration.
15. 12 AAC 52.995. Definitions, is proposed to update the definition for “shared pharmacy services” and establish a definition for “pharmacy technician who holds a national certification”.

The emergency regulations took effect on April 3, 2020, and will expire July 31, 2020. The Board intends to make the emergency regulations permanent.

You may comment on the regulation changes, including the potential costs to private persons of complying with the 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/197699, and using the comment link. The comments must be received not later than 4:30 p.m. on May 15, 2020. 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 8, 2020 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-EmergencyRegs-0420.pdf.

The language of the permanent regulation may be different from that of the original emergency regulation and may include other provisions dealing with the same subject. 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 08.80.165; AS 08.80.168; AS 08.80.261; AS 08.80.295; AS 08.80.330; 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 08.01.075; 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 08.80.165; AS 08.80.168; AS 08.80.261; AS 08.80.295; AS 08.80.330; 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: 4/6/2020
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:  Pharmacist duties, pharmacy interns, pharmacy technicians, pharmacy technician with national certification, license renewal, shared pharmacy services during emergency, refills, labeling, prescriptions by electronic transmission, transfer of a prescription drug order, substitution, emergency preparedness, independent administration of vaccines and related emergency medications, and definitions.

3.   Citation of regulation:  12 AAC 52.060 – 12 AAC 52.995. 

4.   Department of Law file number:  2020200314. 

5.   Reason for the proposed action:  Emergency regulations. 

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 2020 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: 4/6/2020
Prepared by: Jun Maiquis
                     Regulations Specialist