1. A. The pharmacist shall make counseling available to the patient or primary caregiver, or both, concerning proper use of compounded sterile preparations and related supplies furnished by the pharmacy.
2. B. The permit holder shall ensure that pharmacy personnel engaging in compounding sterile preparations are trained and demonstrate competence in the safe handling and compounding of compounded sterile preparations and parenteral solutions, including cytotoxic agents if applicable.
3. C. The permit holder shall maintain records of training and demonstrated competence for individual employees for 5 years.
4. D. The permit holder shall ensure the continuing competence of pharmacy personnel engaged in compounding sterile preparations.

5. E. A pharmacy that compounds sterile preparations shall comply with the following training requirements:

   1. (1) The pharmacy shall establish and follow a written program of training and performance evaluation designed to ensure that individuals working in the designated area have the knowledge and skills necessary to perform the assigned tasks properly and include at least the following:

      1. (a) Aseptic technique with media fill verification at a frequency defined by risk level as described in USP 797 Standards:

         1. (i) 12 months for low and medium risk; and
         2. (ii) 6 months for high risk;
      2. (b) Pharmaceutical calculations and terminology;
      3. (c) Compounding sterile preparation documentation process;
      4. (d) Quality assurance procedures;
      5. (e) Aseptic preparation procedures;
      6. (f) Proper cleansing, gowning, and gloving techniques;
      7. (g) General conduct in the controlled area;
      8. (h) Cleaning, sanitizing, and maintaining equipment used in the controlled area;
      9. (i) Sterilization techniques for high risk preparations; and
      10. (j) Container, equipment, and closure system selection.
   2. (2) Individuals assigned to the controlled area shall successfully complete practical skills training in aseptic technique and aseptic area practices.

   3. (3) Evaluations shall include:

      1. (a) Written testing;
      2. (b) Observation for adherence to aseptic technique and aseptic area policies and procedures; and
      3. (c) Media fill verification as set forth in §E(1)(a) of this regulation.

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)