Md. Code Regs. 10.34.19.15

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

Section 10.34.19.15 - Quality Assurance

The permit holder shall ensure that the compounded sterile preparation retains its potency and sterility throughout the assigned "beyond use" dating period through a written quality assurance program that includes:

A. A reasonable effort by the pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions before dispensing, during transport, and at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration, as set forth by the product manufacturer and established standards and literature, with each compounded sterile preparation dispensed;

B. The phases of compounded sterile preparation, distribution, storage, administration, and directions for use for each type of preparation dispensed;

C. Environmental sampling for microbial organisms in laminar air flow workstations and clean rooms is performed according to methods and schedules specified by USP 797 Standards and if microbial contamination is suspected, for example, in the event of positive media fill verification results;

D. Laminar air flow workstations, biological safety cabinets, and compounding aseptic isolators certified by a trained and qualified operator;

E. Clean room and anteroom certification by a trained and qualified operator according to USP 797 Standards;

F. The proper disposal in accordance with accepted professional standards and applicable State and federal laws of unused drugs and materials used in the preparation of compounded sterile preparations, including antineoplastic agents and hazardous materials;

G. A formal written review process to report and evaluate compliance with this chapter; and

H. A process that complies with applicable USP 797 Standards for performing sterility checks or pyrogen testing, or both, for applicable compounded sterile preparations.

Md. Code Regs. 10.34.19.15

Regulations .15 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .15C, E amended effective February 23, 2009 (36:4 Md. R. 354)