Md. Code Regs. 10.34.19.09

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.19.09 - Minimum Facility Requirements

A. Controlled Environment.

(1) The pharmacy shall have a controlled environment that meets USP 797 Standards.

(2) A health care practitioner shall ensure that the controlled environment is:

(a) Accessible only to designated personnel; and

(b) Used only for the preparation of compounded sterile preparations, or such other tasks that require a controlled environment.

(3) The permit holder shall ensure that the controlled environment is:

(a) Structurally isolated from other areas within the sterile compounding facility by means of restricted entry or access; and

(b) Air conditioned to maintain a temperature of the controlled environment according to USP 797 standards.

B. Controlled Environment-Clean Room. The permit holder shall ensure that the clean room in the controlled environment:

(1) Meets USP 797 Standards for design and USP 797 performance criteria quality standards for clean rooms;

(2) Contains no sinks or floor drains;

(3) Contains work surfaces constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized;

(4) If cytotoxic agents are routinely used in compounding preparations, contains room or rooms equipped with special pressurization requirements consistent with USP 797 Standards and the National Institute for Occupational Safety and Health (NIOSH) standards;

(5) Has in place appropriate environmental engineering control devices capable of maintaining USP 797 air-quality standards during normal compounding activity; and

(6) Contains the following equipment:

(a) A laminar airflow workstation or other suitable International Standards Organization (ISO) Class 5 compounding environment;

(b) Waste containers that are approved by Occupational Safety and Health Administration (OSHA) for used needles and syringes, and for chemotherapy waste; and

(c) Ancillary supplies required for proper compounding.

C. Controlled Environment-Anteroom. The permit holder shall ensure that the anteroom in the controlled environment:

(1) Meets USP 797 Standards for design and USP 797 performance criteria quality standards for anterooms; and

(2) Contains the following equipment:

(a) A sink with hot and cold running water;

(b) Waste containers for personal protective equipment;

(c) An eyewash station or sink design suitable for flushing an eye injury; and

(d) A hazardous waste spill kit, if applicable.

D. The requirements specified in §§B(1) and C(1) of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with the:

(1) Compounding aseptic isolator conditions set forth in USP 797 Standards; and

(2) Isolator vendor or manufacturer specifications.

Md. Code Regs. 10.34.19.09

Regulations .09 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .09 amended effective February 23, 2009 (36:4 Md. R. 354)
Regulation .09 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016