Notice of Proposed Changes Relating to the Practice of Pharmacy, and Relating to the Administration of Vaccines and Related Emergency Medications in the Regulations of the Board of Pharmacy
Brief Description: The Board of Pharmacy proposes to update various regulations relating to the requirements for a pharmacy intern license, pharmacist duties, continuing education requirements for a pharmacist administering vaccines or related emergency medications, general guidelines for pharmacies, prescription drug order records and information, transfer of a prescription drug order, mandatory patient counseling, and establishing standards for the independent administration of vaccines and related emergency medications.
The Board of Pharmacy (Board) proposes to adopt regulation changes in Title 12, Chapter 52, of the Alaska Administrative Code including the following:
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12 AAC 52.120. Review of pharmacist intern license application, is proposed to be changed to alter the requirements for a pharmacist intern license.
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12 AAC 52.210. Pharmacist duties, is proposed to be changed to alter the provisions related to duties that may only be performed by a pharmacist.
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12 AAC 52.320. Continuing education requirements for pharmacists, is proposed to be changed to alter the continuing education requirements for a pharmacist administering vaccines or related emergency medications.
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12 AAC 52.400. General guidelines for pharmacies, is proposed to be changed to update the guidelines for pharmacies that the board adopts by reference.
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12 AAC 52.450. Prescription drug order records, is proposed to be changed to alter the prescription drug order records requirements by a pharmacy.
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12 AAC 52.460. Prescription drug order information, is proposed to be changed to alter the information a prescription drug order must include before a pharmacist may fill it.
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12 AAC 52.500. Transfer of a prescription drug order, is proposed to be changed to alter the provisions related to transfer of a prescription drug order between pharmacies.
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12 AAC 52.585. Mandatory patient counseling, is proposed to be changed to alter the requirements for mandatory patient counseling by a pharmacist or pharmacy intern providing prescription services.
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12 AAC 52.992. Independent administration of vaccines and related emergency medications, is a proposed new section that establishes requirements for independent administration of vaccines and related emergency medications by a pharmacist.
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 Marilyn Zimmerman, Paralegal, 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/184197, and using the comment link. The comments must be received not later than 5:00 p.m. on February 13, 2017. Comments received after this deadline will not be considered by the Board.
You may submit written questions relevant to the proposed action to Marilyn Zimmerman, Paralegal, Division of Corporations, Business and Professional Licensing, P.O. Box 110806, Juneau, AK 99811-0806 or by e-mail at marilyn.zimmerman@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 Marilyn Zimmerman at (907) 465-2532 or marilyn.zimmerman@alaska.gov not later than February 6, 2017 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 Marilyn Zimmerman at (907) 465-2532 or marilyn.zimmerman@alaska.gov, or go to https://www.commerce.alaska.gov/web/portals/5/pub/PHA-0117.pdf.
A copy of material proposed for adoption by reference is available on the Alaska Online Public Notice System, or go to https://www.commerce.alaska.gov/web/portals/5/pub/PHA_FacilityStandardsPharmacies_November.2016.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 08.80.005; AS 08.80.030; AS 08.80.110; AS 08.80.116; AS 08.80.147; AS 08.80.157; AS 08.80.165; AS 08.80.168; AS 08.80.261; AS 08.80.330; AS 08.80.480
Statutes Being Implemented, Interpreted, or Made Specific: AS 08.01.075; 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 08.80.165; AS 08.80.168; AS 08.80.261; AS 08.80.330; AS 08.80.480
Fiscal Information: The proposed regulation changes are not expected to require an increased appropriation.
DATE: 1/9/2017
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 intern license application, pharmacist duties, continuing education requirements, general guidelines for pharmacies, prescription drug order records and information, transfer of a prescription drug order, mandatory patient counseling, and independent administration of vaccines and related emergency medications.
3. Citation of regulation: 12 AAC 52.120, 12 AAC 52.210, 12 AAC 52.320, 12 AAC 52.400, 12 AAC 52.450, 12 AAC 52.460, 12 AAC 52.500, 12 AAC 52.585, and 12 AAC 52.992.
4. Department of Law file number: To be assigned.
5. Reason for the proposed action: Compliance with new state statute; update and clarification of current 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.
Another state agency: None.
A municipality: None.
8. Cost of implementation to the state agency and available funding (in thousands of dollars):
No costs are expected in FY 2017 or in subsequent years.
9. The name of the contact person for the regulation:
Donna Bellino, Licensing Examiner
Alaska Board of Pharmacy
Division of Corporations, Business and Professional Licensing
Telephone: (907) 465-2589
E-mail: donna.bellino@alaska.gov
10. The origin of the proposed action: Board of Pharmacy.
11. Date: 1/9/2017
Prepared by: Jun Maiquis
Regulations Specialist
(907) 465-2537