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. When evaluating an application for a waiver pharmacy, the Board shall consider whether: The pharmaceutical specialty service is necessary to meet a specific therapeutic need; The location is accessible without endangering public health and safety; The pharmacy is properly equipped to perform the pharmaceutical specialty; 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 A policy and procedure manual is included with the application which sets forth a detailed description of the pharmacy operation. No one criterion or combination of criteria listed in §B of this regulation shall be binding upon the Board. The Board's determination of whether a limited practice or setting constitutes a pharmaceutical specialty is final.