NAPRA has introduced three sets of Model Standards for pharmacy compounding in sterile and non-sterile preparations. In December 2017, NAPRA adopted all three Model Standards which classify compounding based on levels of hazard and risk. Level C is for hazardous sterile and non-sterile compounds using certain drugs. Levels A and B are for non-hazardous sterile compounds, while Level B is also for some non-sterile compounds involving allergenic or hormonal drugs. Level A includes many simple non-sterile preparations. A risk assessment considers factors like drug, dosage form, exposure risk and is needed for certain compounds.

1. Introduction to NAPRA
Model Standards for
Pharmacy Compounding
Brittany Sharkey, PhT

2. NAPRA has introduced 3 sets of Model
Standards for Pharmacy Compounding
• Model Standards for Pharmacy Compounding
of Hazardous Sterile Preparations –
November 2016
• Model Standards for Pharmacy Compounding
of Non-Hazardous Sterile Preparations –
November 2016
• Model Standards for Pharmacy Compounding
of Non-Sterile Preparations – March 2018

3. In December 2017, Council made
the decision to adopt all 3 Model
Standards for Pharmacy
Compounding.

4. Why?

5. Compounding Classifications
• Level C (Hazardous) Sterile &
Non-Sterile
• Level A & B (Non-Hazardous)
Sterile
• Level B Non-Sterile
• Level A Non-Sterile

6. Level C
• Any compound involving any amount and all
dosage forms of drugs that are listed in
NIOSH Group 1
• Compounds involving NIOSH Groups 2 and
3 drugs where large quantities are used
routinely
– Based on completion of Risk Assessment
• Any compound involving hazardous drugs
classified by WHMIS as a health hazard
– Drugs irritating to the respiratory tract, skin and
mucous membrane

7. Level A & B (Non-Hazardous)
Sterile
• Any sterile compound that does not
involve hazardous drugs

8. Level B Non-Sterile
• Compounds including drugs that are
considered allergenic products, or
hormones

9. Level A Non-Sterile
• Many simple and moderate non-sterile
preparations can be classified as Level A
– All based on risk assessment of the
preparation
• Mixing and reconstituting may not be
classified as compounding, it is recommended
that personnel complete these activities under
Level A conditions

10. Level A VS Level B Non-Sterile

14. Risk Assessment
Not a “one size fits all” by drug

15. Elements of a Risk Assessment
• Drug
• Dosage form
• Risk of exposure
• Packaging
• Manipulation
• Documentation of alternative
containment strategies and/or work
practices

16. Factors to consider when
completing a risk assessment
• Complexity
• Need for verification and
uninterrupted workflow
• Frequency
• Risk
• Concentration
• Quality

18. Things to consider…
If it is necessary to compound a
preparation requiring procedures or
processes which are not currently in
place in the pharmacy, documentation
needs to include what the risks are, the
steps to be take to mitigate the risk and
references stating that the steps will
minimize the risk

19. Risk assessments must be
evidence & data based

20. Thank You
Questions?