are the differences between USP <795>, <797>, and <800>?
- USP <795>:
pharmaceutical compounding of NON-sterile preparations
- USP <797>:
pharmaceutical compounding of sterile preparations
- USP <800>:
handling of hazardous drugs in the healthcare setting
- If compounding a product that includes a hazardous drug,
both applicable chapters should be followed.
- Follow USP <795> and <800> when compounding
a NON-sterile product containing a hazardous drug.
- Follow USP <797> and <800> when
compounding a sterile product containing a hazardous drug.
- See our CEs, USP Chapter <800> - Handling
Hazardous Meds in the Healthcare Setting, and Compounding: Sterile Compounding and USP Chapter
<797>, and Compounding: A
Summary of Complex Non-Sterile Compounding, for more on hazardous meds and
are hazardous meds defined?
- Use NIOSH as a tool or aid when creating
your facility-specific hazardous med list, as the NIOSH list is not
- The NIOSH list of hazardous meds includes
drugs approved for use through the FDA Center for Drug Evaluation and Research
(CDER). Drugs evaluated through the
FDA Center for Biologic Evaluation and Research (CBER) are NOT included in
the hazardous med list. These include vaccines,
blood and blood components, allergenics, somatic cells, gene therapy, tissues,
and recombinant therapeutic proteins (e.g., Bacillus Calmette Guerin [BCG]).22
- NIOSH defines a med as hazardous if it
has one or more of the following characteristics in humans or animals:2,20
- teratogenicity or
other developmental toxicity (causing harm to an unborn baby).
- reproductive toxicity
(interference with normal reproduction such as effects on fertility in either
- organ toxicity at
low doses (harming organs, such as heart, liver, lungs, etc).
(damaging the genetic information in a cell, which could lead to cancer).
- The NIOSH list of hazardous meds is
periodically updated, therefore newer meds may not be included on the current
list. The proposed 2020 update only
includes meds approved through December 2015.
For newer drugs or drugs approved through CBER, consider the following
as an indicator of their risk: structure
and toxicity profiles that are the same as existing hazardous drugs, information
in product labeling, peer-reviewed literature about the hazard potential, or safety
data sheets, until further guidance is available.2,20,22 For investigational drugs, if the mechanism
of action suggests there may be concern, treat these as hazardous drugs until
data are available to exclude them.22
are hazardous meds classified?
- Previously, hazardous meds were divided
into THREE groups:2
- group one: antineoplastic drugs (per the American
Hospital Formulary Service [AHFS] classification)
two: NON-antineoplastic drugs
- group three: meds with primarily reproductive risk
(i.e., to men and women who are trying to conceive and women who are either
pregnant or breastfeeding).
- These three groups of hazardous meds may
have led to some confusion because categorizing a med as “antineoplastic”
doesn’t tell the whole story. For
example, meds used to treat cancer aren’t all cytotoxic. Plus, some antineoplastics have non-cancer
- There are likely to be TWO groups or tables
in the 2020 NIOSH update, based on the draft guidance:20,22
- table one: known or probable carcinogens according
to the National Toxicity Program (NTP) or International Agency for Research
on Cancer (IARC) or hazardous meds with special handling instructions in their
- table two: meds not thought to be carcinogens according
to NTP or IARC, but are defined as hazardous by NIOSH due to other
adverse effects (e.g., developmental toxicity, organ toxicity, reproductive
- Antineoplastics can be included in table one or
but only those in table one are known or probable
- You can access the full NIOSH list of
hazardous meds at https://www.cdc.gov/niosh/topics/hazdrug/default.html.
training is required for staff who work with hazardous meds?
- Designate one person to oversee compliance with
- Tailor training to the applicable job functions of personnel
(receiving, compounding, dispensing, administering).1
- All staff involved with hazardous meds must be fully
trained prior to working with hazardous meds independently.1
- Training and demonstration of competency are
required ANNUALLY and must include:1
- review of facility designated list of hazardous drugs
and any policies and procedures related to hazardous drugs.
- proper use of equipment and PPE.
- what to do in case of exposure or a spill.
- proper disposal of hazardous meds and contaminated
containment strategies and/or work practices should be followed when handling
<800> containment strategies and work practices to limit exposure to
hazardous meds must ALWAYS be adhered to for:1
- hazardous med active pharmaceutical ingredients (APIs)
- antineoplastics (per 2016 NIOSH) or table one antineoplastics
(per 2020 NIOSH) requiring manipulation.
certain types of hazardous meds (see below), facilities will be allowed to customize
their containment strategies/work practices based on an “assessment of risk”
for individual meds to determine how best to protect their employees (see the
requirements for assessment of risk in the next section).1 These risk assessments can be done for the
following types of NIOSH hazardous med classifications:1
- antineoplastics (NIOSH 2016) or table one antineoplastics
(NIOSH 2020) that DO NOT require manipulation (e.g., only packaging, counting)
- NON-antineoplastic (NIOSH 2016 and 2020)
- table two antineoplastics (NIOSH 2020)
- meds with reproductive risk (will be identified in
blue in table two in NIOSH 2020)
- final dosage forms of compounded hazardous meds
example containment/work practice strategies to limit exposure to hazardous
- Use disposable or dedicated equipment (e.g., counting
trays, spatulas) for counting hazardous meds that only require counting or
repackaging of final dosage forms.1 Use wipes (wetted with an appropriate
solution), instead of spray bottles to decontaminate reusable spatulas and counting
trays after EACH use. Spray bottles
could spread hazardous residue.1
- Regardless of risk assessments, DO NOT USE automatic
counting or packaging machines for any antineoplastic (NIOSH 2016) or table
one antineoplastics (NIOSH 2020) tablets or capsules.1 Use of these machines can create residue
that could contaminate both the machine and potentially other medications
used in these devices.1
- If your facility compounds sterile and non-sterile
hazardous meds, it may be easier to maintain the sterile environment if these
compounding areas are separated. Sterile
and non-sterile primary engineering controls can be located in the same room
AS LONG AS sterile requirements are maintained. However, this is not recommended.1
- Crushing or splitting hazardous meds is considered compounding. Where and how this is done may depend on
the assessment of risk. For example, table
one antineoplastics (NIOSH 2020) must be crushed in a chemo hood. However, based on the assessment of risk,
crushing of some non-antineoplastics or table two antineoplastics (NIOSH
2020) may be allowed on the floor in a containment device (e.g., RxCrush).1 See our CE, USP Chapter <800> =
Handling Hazardous Meds in the Healthcare Setting, for details on these engineering
controls and containment strategies during compounding.
are the assessment of risk requirements?
hazardous meds that meet the appropriate criteria (see above), an assessment
of risk can be performed to determine the containment strategies/work practices
needed to protect employees. This
assessment will be based on the medication’s risk and how it will be used in
- The following must be included in the assessment of risk:1,18
- hazardous med classification (e.g., NIOSH 2016: antineoplastic, NON-antineoplastic,
reproductive risk; NIOSH 2020: table
one or two antineoplastic, table one or two NON-antineoplastic)
- dosage form (How can the hazardous med potentially
enter the body: skin, inhalation, ingestion,
- risk of exposure (What PPE is available? What engineering controls are available?)
- manipulation (How is med handled? How often is med handled?)
- packaging (description of packaging in which hazardous
med is received)
- Documentation must include the alternate containment
strategy/work practice that will be used to minimize exposure.1
- For example, alternate containment strategies/work
practices could include:19
unit-dose or unit-of-use product to eliminate need for manipulation or compounding.
- use of a
dedicated plastic tote (decontaminated after each use) to transport hazardous
meds from the pharmacy to other areas of the facility.
- labeling lidded
automated dispensing cabinet bins so anyone who accesses or administers these
meds is reminded of necessary PPE to use when administering or handling.
- Assessments of risk for hazardous meds must be
reviewed (and documented) at least once yearly.1 An example hazardous drug assessment
of risk template can be found at https://www.pppmag.com/documents/V14N3/pdfs/ppp_1703_Assessment_of%20Risk_Template.pdf.4
are the cleaning requirements with hazardous meds?
- All areas and equipment where hazardous meds are handled
need to be deactivated, decontaminated, and cleaned. In addition, areas where hazardous drugs are
involved in sterile compounding must be disinfected.
- Follow policies and procedures for deactivation, decontamination,
cleaning, and disinfecting. The requirements
will vary based on the situation.
- Two pairs of chemotherapy gloves and disposable impermeable
gowns are required for these activities.1
- Eye protection may be needed if splashing is
- Respiratory protection may be needed if dust particles
- Use wipes (wetted with an appropriate solution), instead
of spray bottles. Spray bottles could
spread hazardous residue.1
- See our CE, USP Chapter <800> = Handling
Hazardous Meds in the Healthcare Setting, for information on surface sampling.
personal protective equipment (PPE) should be used?
- USP <800> and NIOSH both provide detailed
information on the use of PPE (e.g., gloves, gowns, head, hair, shoe, and
sleeve covers; eye and face protection; respiratory protection).1,2
USP plans to clarify guidance to note
that the requirements for antineoplastic hazardous meds will only refer to antineoplastics
in table one (known/probable carcinogens) of the updated 2020 NIOSH list.21 The antineoplastic handing requirements in
USP <800> will not apply to non-antineoplastics in table one or medications
in table two of the updated 2020 NIOSH list.
- Single gloves are appropriate for unpacking or
receiving orders of hazardous meds, unless a spill occurs (then double
gloves are needed).
- Double gloves and two pairs of shoe covers are appropriate
for sterile and non-sterile compounding.
- The outer pair of
gloves must be sterile for sterile compounding.
- Eye /face protection is appropriate when using liquids
that can splash.
- Gowns are appropriate for sterile and non-sterile compounding. Gowns must be impermeable and disposable.
- For more details and additional practical examples
concerning PPE use, refer to table 5 in the 2016 NIOSH list of antineoplastic
and other hazardous drugs in healthcare settings (https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf)
or chapter 8 of the 2020 NIOSH managing hazardous drug exposures: information for healthcare settings draft
- For medications that undergo an assessment of risk,
follow your facilities policies and procedures for PPE requirements.
- Single gloves may be deemed appropriate for counting
some hazardous meds in capsule form, but double gloves may be required for
prepping an intravenous dose of the same med.
- See our CE, USP Chapter <800> = Handling
Hazardous Meds in the Healthcare Setting, for specific requirements on spill
kits and use of PPE during spills.
are specific pregnancy- and conception-related
- Always follow policies and procedures when handling
hazardous meds. However, consider
additional precautions during pregnancy, while breastfeeding, or if trying to
conceive. Note that it is appropriate
for women who are pregnant or breastfeeding, or women or men who are trying
to conceive, to work with their supervisor on possible alternative work assignments
(i.e., involving no or less handling of hazardous meds).3
- Refer to product labeling to see if there are
specific recommendations for pregnant or breastfeeding women, or for men or
women trying to conceive. For example
(note this list is NOT inclusive), product labeling states pregnant
- (or women who may become pregnant) should not handle
dutasteride capsules (Avodart, Jalyn). If contact is made with leaking capsules,
wash the area immediately with soap and water.13-16
- (or women who
may become pregnant) should not handle crushed or broken finasteride tablets
Finasteride tablets are coated and will prevent contact with the
active ingredient during normal handling provided that the tablets have not
been broken or crushed.9-12
- should generally
avoid direct care of patients who are receiving aerosolized ribavirin (Virazole). Refer to U.S. product labeling for specific
- should avoid exposure to testosterone gel application
sites in men, as well as used testosterone packets, patches, or pumps (Androderm,
AndroGel, Testim, etc).5,6 If unwashed or unclothed skin to which gel has
been applied (or unwashed clothing exposed to testosterone gel) comes in
direct contact with the skin of a pregnant woman, wash the general area of
contact on the woman with soap and water as soon as possible.5,6
medical surveillance is recommended for healthcare workers who handle hazards
- Medical surveillance is used in conjunction with exposure
control programs, engineering controls, safe work practices, and PPE to minimize
adverse effects to staff who could be exposed to hazardous drugs.1 Expect
to be involved in a medical surveillance program if you handle hazardous
- See our CE, USP Chapter <800> = Handling
Hazardous Meds in the Healthcare Setting, for facility and employee
involvement and responsibilities in medical surveillance programs.
and how will USP <800> be enforced?
- USP <800> will go into effect December 1, 2019.17
- See our CE, USP Chapter <800> - Handling
Hazardous Meds in the Healthcare Setting, for what USP <800> recommends
to be included in policies and procedures related to hazardous meds.
- Enforcement of compliance with USP <800> is
the responsibility of regulators (e.g., FDA, state board of pharmacy). Regulatory bodies may have a different official
date for enforcement. USP has no role
in enforcing USP <800>.17