(1) The following requirements must be met by those pharmacies that prepare antineoplastic drugs to ensure the protection of the personnel involved:
(a) All antineoplastic drugs must be compounded in a vertical flow, Class II, biological safety cabinet;
(b) Protective apparel must be worn by personnel compounding antineoplastic drugs. This must include gloves, gowns with tight cuffs, and appropriate equipment as necessary;
(c) Appropriate safety and containment techniques for compounding antineoplastic drugs must be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals;
(d) Written procedures for handling both major and minor
spills of antineoplastic agents must be included in the policy and procedure manual; and
(e) Prepared doses of antineoplastic drugs must be dispensed, labeled with proper precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.