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:

1. A. Preparation of compounded sterile preparations within the pharmacy or decentralized pharmacy;
2. 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;
3. C. Labeling of containers of compounded sterile preparations compounded within the pharmacy;
4. D. Recording of transactions of the pharmacy 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
5. E. Ensuring that licensed pharmacists 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.

Authority: Health Occupations Article, §§12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland

Effective date: February 19, 1990 (17:3 Md. R. 299)

Regulation .04B amended effective July 20, 1992 (19:14 Md. R. 1284)

Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284)

Regulations .01 — .06 repealed and new Regulations .01 — .16 adopted effective September 10, 2007 (34:18 Md. R. 1580)

Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .02 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .03B amended effective February 23, 2009 (36:4 Md. R. 354); February 1, 2016 (43:2 Md. R. 127)

Regulation .05A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .06A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .06A, D amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .07A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .09 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .09A amended effective February 1, 2016 (43:2 Md. R. 127)

Regulation .10 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .11 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .13 amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .14E amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .15C, E amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .16A amended effective February 23, 2009 (36:4 Md. R. 354)

Regulation .17 adopted effective February 1, 2016 (43:2 Md. R. 127)

Regulation .18 adopted effective February 1, 2016 (43:2 Md. R. 127)

Regulation .19 adopted effective February 1, 2016 (43:2 Md. R. 127)