NOTICE OF PUBLIC HEARING
Pursuant to Hawaii Revised Statutes (“HRS”) section 448E-4 and Chapter 91, notice is hereby given that the Board of Pharmacy (“Board”) will hold a public hearing on Thursday, March 12, 2015 at 9:00 a.m. in the PVL Examination Room, Third Floor, King Kalakaua Building, Department of Commerce and Consumer Affairs, 335 Merchant Street, Honolulu, Hawaii, to hear all persons interested in the proposed amendments to Hawaii Administrative Rules (“HAR”) Chapter 16-95 pertaining to pharmacists and pharmacies.
The purposes of the proposed amendments are to: (1) Align the administrative rules with various statute (law), which was amended pursuant to Act 50, SLH 2010, which recognizes the pharmacy practical experience in territories of the United States; (2) Add new and amend existing definitions for clarification; (3) Replaces the term “Pharmacist assistant” with “Pharmacy Intern”; (4) Repeals the photo requirement for pharmacist applicants; (5) Repeals the application for exam deadline of sixty days; (6) Update the practical experience requirement for pharmacists to 1,500 hours; (7) Clarify the requirements for a temporary license; (8) Update the requirements for a pharmacy permit by deleting the requirement for an inspection by the Regulated Industries Complaints Office and allowing pharmacies to maintain pharmacy reference materials electronically; (9) Amend the requirements for a wholesale prescription drug distributor to be in compliance with federal regulations; (10) Clarify language to include HRS 436B-19, 461-21 and HAR 16-95-110 as sections the Board may use to determine whether an applicant is fit to hold a license or permit; (11) Amend the education documentation required for a pharmacist license; (12) Deletes the notary requirement for a reciprocity pharmacist applicant who is self-employed; (13) Delete the section, “Notice of renewal” as renewal applications are no longer automatically mailed to licensees; (14) Amends the “date for filing” to include “online” renewal submissions; (15) Clarify the restoration requirements for a pharmacist restoring his/her license during the first, second or third year; (16) Clarify the supervision by a registered pharmacist who must be physically present in the area where the pharmacy intern or pharmacy technician is working; (17) Clarify the requirements of a registered pharmacist presence during the hours of operation of the prescription area and the use of night cabinets; (18) Clarify the use of emergency kits; (19) Amends the section regarding “valid prescription” to clarify the term “practitioner” in lieu of “prescriber” and the information that is required for a prescription to be considered “valid”, including oral prescriptions and allows a pharmacist or pharmacy intern to accept an oral or faxed prescription from a practitioners agent. “Coded” prescriptions was deleted; (20) Clarify the scope of practice and supervision of a pharmacy intern; (21) Clarify the scope of practice of a pharmacy technician; (22) Clarifies record keeping requirements for pharmacies and wholesale prescription drug distributors; (23) Amends the violations section to include failing to comply with the pharmaceutical compounding requirements of the United States Pharmacopeia and failure to report disciplinary action taken in another jurisdiction. Also, amended to allow the Board to make recommendations regarding quality improvements to prevent or minimize errors; and (24) Make other non-substantive changes for the purposes of style and clarify.
All interested persons shall be afforded the opportunity to submit data, views, or arguments, orally or in writing, at the time of hearing. All persons wishing to submit written testimony are requested to submit 10 copies of their written testimony by Monday, March 2, 2015, to the Professional and Vocational Licensing Division at the address printed below.
A copy of the proposed rules will be mailed to any person who requests a copy upon receipt of $17.53 for the copy and postage. Please submit your request to the Professional and Vocational Licensing Division at the address noted below or contact the Board’s office at (808) 586-2695.
Copies may be picked up at the following address between 7:45 a.m. and 4:30 p.m., Monday through Friday, excluding holidays: Department of Commerce and Consumer Affairs, Professional and Vocational Licensing Division, 335 Merchant Street, Room 343, Honolulu, Hawaii 96813. The cost of a copy, $15.50, is due and payable at the time of pick up.
Further, the proposed rules may be reviewed in person free of charge at the Professional and Vocational Licensing Division at the address and hours of operation printed above. In addition, the full text of the proposed rules is available and can be downloaded free of charge from the web site of the Department of Commerce and Consumer Affairs:
Individuals who require special needs accommodations are invited to call Lee Ann Teshima at (808) 586-2695 at least four (4) working days prior to the hearing.
Kerri Okamura, Chairperson
Board of Pharmacy
State of Hawaii