MPJE USP <800>
provides practice and quality standards for handling hazardous
USP Chapter <800> provides info on
what? drugs (HDs) to promote patient safety, worker safety, and
environment project
Method of dealing with hazardous material. Consists of five parts:
• Written program describing implementation
• Container labeling (all must be labeled, tagged or marked
with the identity of the material and appropriate hazards)
Hazardous Communication Program • Safety Data Sheets for each HD used; and that SDSs are
readily accessible to personnel during each work shift
• Employee training for those who may be exposed to HD when working
• Personnel of reproductive capability must confirm in writing
that they understand the risks of handling HDs
An informational document that provides written or printed
What are Safety Data Sheets (SDSs)?
material concerning a hazardous chemical. The SDS is prepared
in accordance with the HCS
• HDs must be transported in containers that minimize the risk of breakage
or leakage.
• Pneumatic tubes must not be used to transport any liquid HDs
or any antineoplastic HDs because of the potential for
Transport of HDs breakage and contamination
• When shipping HDs to locations outside the entity, the
entity must consult the Transport Information on the SDS.
• The entity must ensure that labels and accessory
labeling for the HDs include storage instructions, disposal
instructions, and HD category information in a format that is
consistent with the carrier's policies
all entities that store, prepare, transport or administer HDs
USP <800> applies to-
all healthcare personnel who handles HDs
, a list of HDs
facility and engineering controls
USP <800> must be incorporated competent personnel
into an entity's overall
occupational safety plan, this Safe Work Practices
must include:
Proper use of appropriate Personal Protective
Equipment (PPE) Policies for HD waste
segregation and disposal
• HDs that do not require any further manipulation, other than
counting or repackaging of final dosage forms, may be
prepared for dispensing without any further requirements for
containment unless required by the manufacturer or if visual
indicators of HD exposure hazards are present (e.g., HD dust
or leakage).
Dispensing
• Counting or repackaging of HDs must be done carefully.
• Clean equipment should be dedicated for use with
HDs and should be decontaminated after every use.
• Tablet and capsule forms of antineoplastic HDs must not be
placed in automated counting or packaging machines, which
subject them to stress and may create powdered
contaminants.
Entities and personnel involved in compounding HDs must be
compliant with the appropriate USP standards for
compounding including <795> and <797>
• When compounding HD preparations in a C-PEC, a plastic-
backed preparation mat should be placed on the work surface
of the C-PEC.
Compounding • The mat should be changed immediately if a spill occurs and
regularly during use, and should be discarded at the end of
the daily compounding activity.
• Disposable or clean equipment for compounding (such as
mortars and pestles, and spatulas) must be dedicated for use
with HDs.
• Bulk containers of liquid and API HD must be handled
carefully to avoid spills. If used, APIs or other powdered HDs
must be handled in a C-PEC to protect against occupational
exposure, especially during particle generating activities
provides practice and quality standards for handling hazardous
USP Chapter <800> provides info on
what? drugs (HDs) to promote patient safety, worker safety, and
environment project
Method of dealing with hazardous material. Consists of five parts:
• Written program describing implementation
• Container labeling (all must be labeled, tagged or marked
with the identity of the material and appropriate hazards)
Hazardous Communication Program • Safety Data Sheets for each HD used; and that SDSs are
readily accessible to personnel during each work shift
• Employee training for those who may be exposed to HD when working
• Personnel of reproductive capability must confirm in writing
that they understand the risks of handling HDs
An informational document that provides written or printed
What are Safety Data Sheets (SDSs)?
material concerning a hazardous chemical. The SDS is prepared
in accordance with the HCS
• HDs must be transported in containers that minimize the risk of breakage
or leakage.
• Pneumatic tubes must not be used to transport any liquid HDs
or any antineoplastic HDs because of the potential for
Transport of HDs breakage and contamination
• When shipping HDs to locations outside the entity, the
entity must consult the Transport Information on the SDS.
• The entity must ensure that labels and accessory
labeling for the HDs include storage instructions, disposal
instructions, and HD category information in a format that is
consistent with the carrier's policies
all entities that store, prepare, transport or administer HDs
USP <800> applies to-
all healthcare personnel who handles HDs
, a list of HDs
facility and engineering controls
USP <800> must be incorporated competent personnel
into an entity's overall
occupational safety plan, this Safe Work Practices
must include:
Proper use of appropriate Personal Protective
Equipment (PPE) Policies for HD waste
segregation and disposal
• HDs that do not require any further manipulation, other than
counting or repackaging of final dosage forms, may be
prepared for dispensing without any further requirements for
containment unless required by the manufacturer or if visual
indicators of HD exposure hazards are present (e.g., HD dust
or leakage).
Dispensing
• Counting or repackaging of HDs must be done carefully.
• Clean equipment should be dedicated for use with
HDs and should be decontaminated after every use.
• Tablet and capsule forms of antineoplastic HDs must not be
placed in automated counting or packaging machines, which
subject them to stress and may create powdered
contaminants.
Entities and personnel involved in compounding HDs must be
compliant with the appropriate USP standards for
compounding including <795> and <797>
• When compounding HD preparations in a C-PEC, a plastic-
backed preparation mat should be placed on the work surface
of the C-PEC.
Compounding • The mat should be changed immediately if a spill occurs and
regularly during use, and should be discarded at the end of
the daily compounding activity.
• Disposable or clean equipment for compounding (such as
mortars and pestles, and spatulas) must be dedicated for use
with HDs.
• Bulk containers of liquid and API HD must be handled
carefully to avoid spills. If used, APIs or other powdered HDs
must be handled in a C-PEC to protect against occupational
exposure, especially during particle generating activities
