Section 15.08. Cytotoxic drugs.

  In addition to the minimum requirements for a pharmacy established by rule of the board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs:

(1)  All cytotoxic drugs shall be compounded in a vertical flow, class II, biological safety cabinet. If non-exposed surfaces become contaminated with cytotoxic agents, no products other than cytotoxic drugs may be compounded in this cabinet until such time as the cabinet is decontaminated utilizing appropriate techniques to eradicate the contaminant.

(2)  Personnel shall be protected by a protective barrier or apparel which shall include gloves, gowns and other applicable protective apparel as described in 29 CFR PART 1910 of OSHA regulations.

(3)  Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals.

(4)  Pharmacy disposal and patient and caregiver education regarding disposal of cytotoxic waste shall comply with all applicable local, state and federal requirements.

(5)  Written procedures for the handling of both major and minor spills of cytotoxic agents shall be developed and shall be included in the pharmacy policy and procedure manual.

(6)  Prepared doses of cytotoxic drugs shall be dispensed, labeled with proper precautions on the primary and shipping container and should be shipped in a manner to minimize the risk of accidental rupture of the primary container.

History: Cr. Register, March, 2000, No. 531 , eff. 4-1-00.