- 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.
Authority: Health Occupations Article, §12-403, Annotated Code of Maryland
Effective date: June 15, 1987 (14:12 Md. R. 1350)
Regulation .04A amended effective January 17, 1994 (20:1 Md. R. 34)
Chapter revised effective October 19, 2009 (36:21 Md. R. 1591)