Sec. 10.34.17.02. Pharmaceutical Specialty

A. The Board may recognize as a pharmaceutical specialty not listed under Regulation .01B(4) of this chapter, upon written application and supporting documentation to the Board by an applicant for a waiver permit.

B. When evaluating an application for a waiver pharmacy, the Board shall consider whether:

(1) The pharmaceutical specialty service is necessary to meet a specific therapeutic need;

(2) The location is accessible without endangering public health and safety;

(3) The pharmacy is properly equipped to perform the pharmaceutical specialty;

(4) The applicant has provided a full and detailed description of the pharmaceutical specialty that clearly substantiates the basis for the request of a waiver permit; and

(5) A policy and procedure manual is included with the application which sets forth a detailed description of the pharmacy operation.

C. No one criterion or combination of criteria listed in §B of this regulation shall be binding upon the Board.

D. The Board's determination of whether a limited practice or setting constitutes a pharmaceutical specialty is final.