Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.17 - Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties
Section 10.34.17.02 - Pharmaceutical Specialty
Universal Citation: MD Code Reg 10.34.17.02
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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