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
