Minnesota Administrative Rules

6800.8005 CYTOTOXIC AGENTS.

Licensed pharmacies that prepare cytotoxic drugs must comply with the requirements in items A to F in addition to the requirements in parts 6800.8000 to 6800.8004.

A.

Cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet.

B.

Protective apparel, such as disposable masks, gloves, and gowns with tight cuffs, shall be worn by personnel compounding cytotoxic drugs.

C.

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

D.

Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.

E.

Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedures manual.

F.

Prepared doses of cytotoxic drugs must be dispensed and shipped in a manner that will minimize the risk of accidental rupture of the primary container.

Statutory Authority:

MS s 151.06

History:

18 SR 1145

Published Electronically:

September 21, 2011