21 NCAC 46 .2807. ANTI‑NEOPLASTIC AGENTS

In addition to the requirements otherwise provided by applicable law and regulations, the following requirements are necessary for those permit‑holders who prepare anti‑neoplastic drugs:

(1)           All anti‑neoplastic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet, or similar preparation area.  There must be adherence to the pharmacy's hood‑cleaning procedures before preparing in the hood a product not classified as an anti‑neoplastic agent.

(2)           Protective apparel shall be worn by personnel compounding anti‑neoplastic drugs. 

(3)           Safety and containment techniques appropriate for compounding anti‑neoplastic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile parenteral products.

(4)           Disposal of anti‑neoplastic waste shall comply with all applicable local, state, and federal requirements.

(5)           Written procedures for handling spills of anti‑neoplastic agents must be developed and must be included in the policy and procedural manual for the permit‑holder.

(6)           Prepared doses of anti‑neoplastic drugs must be dispensed, labeled with precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.

 

History Note:        Authority G.S. 90‑85.6;

Eff. October 1, 1990;

Amended Eff. March 1, 2013; February 1, 2006.