Md. Code Regs. 10.34.19.05

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.34.19.05 - General Requirements

A licensed pharmacist who has appropriate practical and didactic training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy shall control and supervise the section of the pharmacy that prepares compounded sterile preparations and is responsible for, at a minimum, the following:

A. Preparation of compounded sterile preparations within the pharmacy or decentralized pharmacy;

B. Storage of materials pertinent to the preparation of compounded sterile preparations, including drugs, chemicals, and biologicals, and the establishment of specifications for procurement of the materials;

C. Labeling of containers of compounded sterile preparations compounded within the sterile compounding facility;

D. Recording of transactions of the sterile compounding facility as may be applicable to State and federal laws and regulations, as may be necessary to maintain accurate control over, and accountability for, pharmaceutical materials; and

E. Ensuring that licensed health care practitioners meeting the requirements of §A of this regulation, or registered pharmacy technicians under direct supervision of a licensed pharmacist meeting the requirements of §A of this regulation, prepare, compound, and dispense compounded sterile preparations.

Md. Code Regs. 10.34.19.05

Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284)
Regulations .05 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .05 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016