Md. Code Regs. 10.34.19.10

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.19.10 - Minimum Requirements for Equipment

A. The permit holder shall provide at least the following equipment that is maintained in working order:

(1) Adequate refrigerator and freezer space (if applicable);

(2) A sink and wash area in the anteroom;

(3) Appropriate waste containers for:

(a) Used needles and syringes; and

(b) Cytotoxic waste including disposable apparel used in its preparation, if applicable;

(4) Laminar air flow workstation or compounding aseptic isolator that meets USP 797 Standards, dedicated for products other than antineoplastics;

(5) If applicable to types of preparations compounded, biological safety cabinet, or compounding aseptic isolator that meets USP 797 Standards, dedicated for use with antineoplastics or other hazardous sterile preparations;

(6) Appropriate filters and filtration equipment; and

(7) A device for light/dark field examination.

B. If used, the permit holder shall provide the following equipment that is maintained in working order, calibrated, or certified where appropriate:

(1) Autoclave;

(2) Automated compounding devices (for example, total parenteral nutrition compounding pumps);

(3) Electronic balance;

(4) Convection oven;

(5) Thermometers or other temperature device; and

(6) Incubator.

Md. Code Regs. 10.34.19.10

Regulations .10 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .10 amended effective February 23, 2009 (36:4 Md. R. 354)