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.