Md. Code Regs. 10.34.19.11

Minimum Requirements for Supplies.

Effective Feb 23, 200936:4 Md. R. 354Health Occupations Article, §§12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland

A pharmacy engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to:

  1. A. Personal protective equipment:

    1. (1) Sterile gloves;
    2. (2) Masks;
    3. (3) Non-shedding gowns;
    4. (4) Shoe covers;
    5. (5) Hair covers;
    6. (6) Beard covers; and
    7. (7) Other personal protective equipment;
  2. B. Disposable syringes and needles in necessary sizes;
  3. C. Disinfectant cleaning agents as specified in USP 797 Standards, including 70 percent sterile isopropyl alcohol;
  4. D. Disposable lint free towels;
  5. E. Hand washing materials, including antimicrobial skin cleanser;
  6. F. Adequate equipment and materials for antineoplastic or cytotoxic agent spills;
  7. G. Supplies necessary for the aseptic preparation of compounded sterile preparations; and
  8. H. Closed system vial transfer devices (CSTD), as required for cytotoxic compounding, if applicable.

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Regulations .01.06 repealed and new Regulations .01.16 adopted effective September 10, 2007 (34:18 Md.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)

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