Standard Operating Procedure
for work with
Chemical name/class:
Hazardous Drugs – powders, suspensions,
CAS #: Various
solutions (customization required for PHS
drugs – must complete red sections)
PI:
All Duke PIs (customization required for PHSs)
Date:
Building: All Duke Buildings (customization required for PHSs)
Room #:
Designated Work Area for PHSs:
A customized SOP is required for all drugs on the particularly hazardous substances list. All investigational drugs will be
handled as hazardous drugs unless adequate information exists to exclude them. This SOP focuses on hazardous drug
use in research labs. For further information on hazardous drug use at Duke (especially if your use is similar to clinical
usage), please see our Hazardous Drug Policy.
1. Circumstances of Use:
Use this section to describe the circumstances of use, including concentration and quantity for PHS drugs.
2. Potential Hazards:
Hazardous drugs, as defined by the American Society of Health System Pharmacists, are drugs which display one or
more of the following characteristics: genotoxicity, carcinogenicity, teratogenicity or fertility impairment, or serious
organ or other toxic manifestation at low doses in experimental animals or treated patients.
Consult the Safety Data Sheet for hazards associated the material you are working with (you can also list them here).
Pay attention to both health and physical hazards.
For hazardous drugs on the list of Particularly Hazardous Substances (PHSs), this section must indicate that the drug
is a PHS and why, and give a general overview of the hazards. If PHS drugs have other hazards associated with their
use (e.g. corrosive, reactive), those must also be addressed in this SOP. Alternately, this document may refer to
another source of information (such as a lab inventory that includes basic hazard information).
3. Engineering Controls:
If aerosols may be produced, hazardous drugs in powder form (and any suspensions of these drugs) must be
handled in a chemical fume hood, exhausted biological safety cabinet with negative pressure ductwork, or other
exhausted enclosure. Aerosols may be produced during any open handling of dry powder, while crushing tablets,
and during open or pressurized manipulations of suspensions (i.e. sonication or prepping a needle for injection). It is
recommended that labs post this information sheet on Working Safely with Toxic Powders in the area where
hazardous drugs are handled.
4. Work Practice Controls:
 If other specific written procedures are required for work with hazardous drugs on the particularly hazardous
substances list, you must list them here or attach a step-by-step procedure. (If no further procedures are needed
beyond those listed in this template, you can delete this bullet.)
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If animals will be dosed with the drug, the SOP for Handling Animals Dosed with Toxic Chemicals must be
followed, including advanced notification of the animal facility and room and cage labeling requirements.
When possible, order the drug in liquid form, or purchase in pre-weighed amounts, preferably in a sealed vial
with a septum so that the diluent can be injected directly into the vial.
Set up a designated area for work with hazardous drugs and label it.
Determine a means for decontaminating the work area. (Daily HEPA vacuuming or wet cleaning methods (with a
compatible solvent) are required for any work that may generate aerosols. Note that HEPA vacuuming is not
recommended for reactive materials, as they may react with other materials collected in the vacuum, or with
components of the vacuum itself.)
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If weighing dry powders and the balance cannot be located in a fume hood or BSC, tare a container then add the
material to the container in a hood and seal the container before returning to the balance to weigh the powder.
Wash hands before donning and after removing gloves. Gloves or clothing that becomes contaminated must be
changed as soon as possible. Use proper techniques when removing contaminated gloves and gowns.
If using a HEPA vacuum, change the filter inside a chemical fume hood or biological safety cabinet. If the HEPA
vacuum may be used for incompatible materials, maintain a log of vacuum use so that collection of incompatible
materials can be avoided.
Keep containers closed as much as possible.
Once work with hazardous drugs is complete, wipe the work area down with a soap and water solution.
Determine a means for decontaminating the work area for PHS drugs and list it here. (E.g., a mild detergent and
water, or another solvent may be used - as long as the method is compatible with the drug.)
5. Personal protective equipment (PPE):
 For chemotherapy drugs, employees must wear gloves tested and rated for use with chemotherapy drugs. For
other hazardous drugs, chemotherapy-tested gloves should be effective and are recommended.
 Gloves rated for work with the drug you’re using (or chemotherapy-rated gloves) and a fully buttoned lab coat
with sleeves extending to the wrists should be worn when handling drugs in powder-form. When handling
suspensions or solutions, choose a glove that is also protective against the solvent.
 Gloves are required during drug preparation, initial administration, changing of IV bags, and discontinuation of
chemotherapy and other hazardous drugs. If there is a potential for leaking or splashing, double-gloves are
recommended if they will not interfere with technique.
 If there is a potential for splashing, employees must also wear a cuffed gown and a face shield or splash goggles.
Otherwise, wear standard laboratory safety glasses.
 In cases where the arms or torso may be exposed to liquid suspensions or dry particles, wear Tyvek sleeves
and/or gowns (or other air-tight non-woven textile).
6. Transportation and Storage:
 Dry powders must be in sealed, shatter-resistant containers during transportation. If the container is not
shatter-resistant, use a secondary container.
 If the material may be flammable, reactive, or explosive, keep away from heat and open flame.
 Keep hazardous drugs away from any incompatible materials.
7. Waste Disposal:
All unused portions of hazardous drugs, along with the container, must be disposed of as hazardous chemical waste
following your laboratory-specific chemical hygiene plan, Duke University’s Chemical Waste Policy and the
Laboratory Chemical Waste Management Practices.
8. Exposures/Unintended contact:
Contact Employee Occupational Health and Wellness (EOHW) at 919-684-3136 for medical advice on occupational
chemical exposures. For an actual chemical exposure:
 Flush exposed eyes or skin with water for at least 15 minutes, then seek medical attention.
 For situations with risk of inhalation exposure (including spills outside of a chemical fume hood), remove all
persons from the contaminated area and contact the OESO spill team.
 Call 911 from a campus phone or 919-684-2444 from any phone to request assistance if needed. Contact
Employee Occupational Health and Wellness at 919-684-8115 for exposure-related advice.
Report any hazardous drug exposure (skin or eye contact or inhalation of an aerosol or dust) to your supervisor and
Employee Occupational Health and Wellness. The work-related injury or illness report found at:
http://www.hr.duke.edu/benefits/medical/workcomp/report.php should be completed within 24 hours. Follow-up
medical attention should be sought through Duke Employee Occupational Health and Wellness (919-684-3136).
9. Spill Procedure:
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Spills of dry hazardous drug powders outside of a chemical fume hood or other enclosure should be referred to
the OESO spill response team by calling 911 from a campus phone or 919-684-2444 from any phone.
For small spills of liquid suspensions, absorb the spilled material with a suitable absorbent (determined in
advance), then wet-wipe the affected area three times. Place all absorbent and PPE into a bag and seal, then
manage as chemical waste.
For spills of dry hazardous drug powders in a chemical fume hood or other enclosure, wipe up the powder using
a cloth dampened with a suitable absorbent (determined in advance), or wet the powder with a suitable
absorbent and then wipe with a dry cloth. Consider using electrostatic microfiber cleaning cloths, especially if
the powder is likely to carry an electrostatic charge. Alternately (or in addition), a HEPA vacuum (preferably with
electrostatic-charge-neutralization features) may be used for cleaning the spill (but do not use the vacuum for
cleaning incompatible materials). Minimize the fume hood or enclosure opening during this process. Once spill
has been cleaned up, wet-wipe the affected area three times to decontaminate the surface. Place any clean-up
materials into a bag and seal, then submit as hazardous chemical waste (see waste disposal section above)
through OESO Environmental Programs (call 919-684-2794 with questions).
10. Training of personnel:
 All personnel are required to complete the online General Lab Safety session thru the OESO website. This
session includes an introduction to general chemical safety.
 Training on the specific procedures is required for all personnel working with these materials, and must be
documented (topics covered, date, employee names and signatures).
 All personnel shall read and fully adhere to the laboratory-specific SOP for hazardous drugs, and shall document
that they have read it by signing and dating the SOP.
“I have read and understand this SOP. I agree to fully adhere to its requirements.”
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