Haw. Code R. § 16-95-26 - Pharmacy permit

(a) An application for a pharmacy permit shall be filed in duplicate at least fifteen days before a board meeting and must be accompanied by the application fee which shall not be refunded.

(b) The application shall include:

(1) A floor plan of the prescription area which shall diagram the space and location of fixtures such as counters, tables, drawers, shelves, storage cabinets including a locked cabinet, library, sink with hot and cold water, proper sewage outlet, and refrigeration storage equipment;

(2) The name and license number of the pharmacist in charge and any other pharmacists employed;

(3) A letter of verification or bill of sale that the pharmacy has been bought with the effective date of sale if the pharmacy was purchased;

(4) Evidence that the entity is currently registered with BREG. If a corporation, partnership, or limited liability company has been registered for more than one year, a "Certificate of Good Standing" from the department shall be attached. If a corporation, partnership, or limited liability company has been registered for less than one year, a "file-stamped" copy of the document filed with BREG shall be attached;

(5) Evidence that the trade name, if any, is properly registered with BREG;

(6) An attestation that, at a minimum, the pharmacy possesses or has electronic access to the following reference materials:

(A) United States Pharmacopeia National Formulary, and all supplements;

(B) Federal Drug Enforcement Administration regulations;

(C) State uniform controlled substances laws, chapter 329,, HRS.

(D) State food and drug laws, 328 HRS;

(E) State pharmacy law, chapter 461, HRS, and chapter 16-95 HAR;

(F) Prescription files and;

(G) Drug Facts and Comparison or other current drug information guide; and

(7) An attestation that, at a minimum, the pharmacy possesses the following technical equipment and supplies:

(A) Class A prescription balance or a balance of greater sensitivity and appropriate weights;

(B) Mortar and pestle (glass or porcelain);

(C) Refrigerator;

(D) Bottles and vials of assorted sizes;

(E) Graduates or other similar measuring device; and

(F) Prescription labels.

(c) No permit shall be issued unless all deficiencies have been corrected and approved by the board.

(d) The board may delegate to its executive officer the authority to issue a permit upon receipt of a completed application and documentation evidencing clear compliance with this section.

Notes

Haw. Code R. § 16-95-26

[Eff 5/16/64; am and ren § 16-95-26, 6/22/81; am and comp 12/24/92; comp 12/25/04] (Auth: HRS § 461-4.5) (Imp: HRS §§ 461-4.5, 461-12, 461-14)
The substance of this section is substantially based upon section 16-95-51. [Eff 5/16/64; am 6/11/77; am and ren § 16-95-51, 6/22/81; R 12/24/92] Am and comp 06/22/15; Am and Comp 8/15/2016
The substance of this section is substantially based upon section 16-95-51. [Eff 5/16/64; am 6/11/77; am and ren § 16-95-51, 6/22/81; R 12/24/92]