NAC639.67077. Sterile hazardous drugs: Safety procedures for storage, handling, compounding and disposal.

     1. A pharmacy engaged in the practice of compounding sterile hazardous drugs shall:

     (a) Store the components of the hazardous drugs separately from all the other inventory at the pharmacy and in such a manner and location as to minimize the contamination of other drugs in and employees of the pharmacy;

     (b) Handle the components of the hazardous drugs with caution by using appropriate gloves during preparation, handling and disposal of the components of the hazardous drug or final compounded drug product;

     (c) Compound the hazardous drugs pursuant to the requirements set forth in NAC 639.661 to 639.690, inclusive, and applicable to the risk level of the compounded hazardous drugs;

     (d) Ensure that an employee of the pharmacy involved with compounding hazardous drugs wears personal protective equipment, including, without limitation, gowns, gloves, face masks, hair covers, shoe covers or dedicated shoes, and, if the hazardous drugs contain one or more antineoplastic agents or it is recommended by the drug manufacturer, double gloves or chemotherapy gloves;

     (e) Dispose of all waste relating to the compounding of the hazardous drugs in a manner that complies with any applicable state, federal and local laws and regulations; and

     (f) Ensure that any employees of the pharmacy who are known to the pharmacy to be at special risk with regard to the properties of the hazardous drugs are limited from exposure to those drugs.

     2. A pharmacy shall ensure that the process of compounding sterile hazardous drugs is performed only in an ISO Class 5 environment in either a biological safety cabinet or a compounding aseptic containment isolator if one or more of the components of the hazardous drug are:

     (a) An antineoplastic drug;

     (b) A radiopharmaceutical drug; or

     (c) A drug whose manufacturer has recommended that the drug only be compounded in an ISO Class 5 environment in either a biological safety cabinet or a compounding aseptic containment isolator.

     3. The biological safety cabinet or compounding aseptic containment isolator described in paragraph (c) of subsection 2 must be vented to outside air during the compounding process through the use of high efficiency particulate air filtration if one or more of the components of the compounded hazardous drug are antineoplastic drugs.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)