Hawaii Board of Pharmacy Laws and Rules Subcommittee Meeting 3/21/2013 Agenda

Date	2013/03/21
Time	08:00 AM
Recuring
Event status	Handicap access, ADA Coordinator info: Lee Ann Teshima, 808-586-2695
Title	Board of Pharmacy Laws and Rules Subcommittee
Location	King Kalakaua Conference Room King Kalakaua Building 335 Merchant Street, 1st Floor Honolulu, HI 96813
BOARD OF PHARMACY LAWS AND RULES SUBCOMMITTEE AGENDA Date: Thursday, March 21, 2013 Time: 8:00 a.m. - 9:00 a.m. Place: King Kalakaua Conference Room King Kalakaua Building 335 Merchant Street, First Floor Honolulu, Hawaii 96813 1. Call to Order. 2. Chair's Report a. Announcements and Introductions b. Approval of Minutes of the January 17, 2013 Meeting 3. HRS 461-15 Miscellaneous Permits a. Review of the current miscellaneous permit categories to determine if they are necessary. b. Out-of-State pharmacies and the requirement of a pharmacist or pharmacists in the out-of-state pharmacy to have a Hawaii licensed pharmacist. c. Limited pharmacy practice or virtual pharmacy practice (Pharmacist engaging in the practice of pharmacy without the involvement of the physical storage and dispensing of drugs). d. Dispensing of medical devices. e. Compounding pharmacies. f. Pharmacy Benefit Managers 4. Old Business a. Diversion/Impaired Practitioner or Pharmacists Programs - Review and Discussion of Latest Draft c. Pharmacy Technicians d. Board's Informal Interpretation on Remote Order Entry/Review 4. Next Meeting 5. Adjournment

Hawaii Board of Pharmacy Meeting Feb. 8, 2013

Location: Queen Liliuokalani Conference Room King Kalakaua Building 335 Merchant Street 1st Floor Honolulu Hawaii 96813

BOARD OF PHARMACY
Professional and Vocational Licensing Division
Department of Commerce and Consumer Affairs
State of Hawaii

AGENDA

Date: Friday, February 8, 2013 - New Date

Time: 9:00 a.m.

Place: Queen Lilioukalani Conference Room - New Room
King Kalakaua Building
335 Merchant Street, First Floor
Honolulu, Hawaii 96813

1. Call to Order, Public Notice, Quorum
2. Chair's Report (Mark Brown)
a. Announcements and Introductions
b. Additions/Additional Distribution to Agenda
c. Approval of the Previous Minutes - January 17, 2013 Meeting
3. Executive Officer's Report
a. 2013 Legislature

4. Correspondence
a. State of Emergency Policies/Procedures for Pharmacists
b. Limited Services Pharmacy, Keith McFalls

5. Old Business
a. HAR Title 16, Chapter 95 - Status Report
6. Open Forum (Public comment on issues on the agenda, or not on the agenda for the Board's consideration at the next meeting.)
7. Applications
a. Ratification Lists
b. Applications
1) Patricia A. Warren

8. Next Meeting: TBA
King Kalakaua Conference Room
King Kalakaua Building
335 Merchant Street, First Floor
Honolulu, Hawaii 96813

9. Adjournment
Individuals who require special needs accommodations are invited to call Lee Ann Teshima, Executive Officer, at (808) 586-2695 at least 4 working days in advance of the meeting.

Hawaii Board of Pharmacy Minutes from December 20, 2012 meeting contains lots of compounding items

To view the minutes, click here

Compounding Items During December 2012 Meeting

The board discussed a number of issues related to compounding including off-label use.  To view the minutes of that meeting, click here

Hawaii Board of Pharmacy Examines Definition of Office Use for Compounds

During the June 21, 2012, Hawaii Board of Pharmacy Meeting, the Board examined  what the state laws in Hawaii pertaining to "office use" for sterile and non-sterile compounding.  The following discussion is recorded in the meeting minutes:

Questions on Hawaii Compounding Laws

The Chair read the email inquiry from a pharmacy student at the University of New Mexico asking:

1. What are the state laws in Hawaii pertaining to “office use’ for sterile and non-sterile compounding? Can 

pharmacies in Hawaii compound preparations in advance that prescribers can use in their office without a patient-specific prescription for either (or both) sterile and non-sterile compounds?

2. Has Hawaii recently amended their laws so that compounding pharmacies may
help with the drug shortage crisis?

Mr. Inafuku stated that HRS 461-15 under the miscellaneous permit, (a)(6) states, “For any person, as 

principal or agent, to conduct or engage in the business of preparing,manufacturing, compounding, packing, 

or repacking any drug without first obtaining a permit from the board to do so;”.

The Vice Chair stated that pharmacies may not compound a product unless they have a patient specific 

prescription.

Mr. Inafuku stated that a miscellaneous permit holder who compounds will still be subject to FDA 

requirements.

The Vice Chair stated it’s compounding vs. manufacturing. A compounded product is
manufacturing but a pharmacist may compound a product pursuant to a pahent specific prescription and that compounding for office use is considered manufacturing.

That was the consensus of the Board.

These board minutes can be found here.