# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 19 — Sterile Pharmaceutical Compounding

#### Regulation .10 Minimum Requirements for Equipment.

*COMAR 10.34.19.10*

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.