PEBC Part I (MCQ) · Competency 1B Distribution (about 20%)

Compounding, Product Preparation & Inventory

These items test NAPRA's non-sterile and sterile compounding standards, hazardous drug handling, beyond-use dating, storage and cold chain, recalls, shortages, narcotic inventory control and product verification.

1B Distribution2 min read6 sections

Checked against the NAPRA Model Standards for non-sterile compounding (2018) and sterile non-hazardous and hazardous compounding (2016); Health Canada recall policy (2022); PHAC vaccine storage guidelines (2023); Narcotic Control Regulations ss. 38, 42-43; NIOSH hazardous drug list (2024); checked 13 Oct 2026. Not affiliated with or endorsed by The Pharmacy Examining Board of Canada (PEBC).

Must-know for the exam

Default non-sterile BUDs without data: water-containing oral 14 days refrigerated, water-containing topical 30 days, non-aqueous up to 6 months.
A published stability study can support a longer BUD only if the preparation is made exactly as studied.
Non-sterile Levels A, B and C reflect complexity and hazard; Level C needs a separate ventilated room.
Sterile preparations are compounded in an ISO Class 5 primary engineering control within an ISO 7 clean room.
Hazardous drugs (e.g., methotrexate, cyclophosphamide) need containment, double chemotherapy gloves, gowns and spill kits.
Health Canada Type I recalls carry a reasonable probability of serious harm or death.
Vaccines and insulin are stored at 2-8 °C in a purpose-built fridge with temperature logs.
Report narcotic and targeted substance losses to Health Canada within 10 days.
Never crush extended-release products such as nifedipine ER.
Investigate barcode mismatches rather than overriding them.

On this page · 6 sections

Traps that cost marks

Using the non-aqueous or topical default for an aqueous oral preparation.
Confusing label-directed reconstitution with compounding.
Treating hazardous oral drugs like ordinary tablets when manipulating them.
Confusing the room classification with the PEC classification.
Not understanding the concept of first air.
Mixing up the order of recall types.
Telling patients to stop essential therapy without a replacement.
Using domestic bar fridges or door storage for vaccines.

How this is tested on Part I

Questions describe a compounding request, a storage problem or an inventory event and ask for the correct BUD, precaution or next step.

Compounding records

Master formulation record plus a compounding record for each preparation (ingredients, lots, quantities, staff, BUD).

Reconstitute commercial products exactly per the label; that is not compounding.

Avoid benzyl alcohol and propylene glycol excipients in neonates.

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Exam-style questions

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Educational practice material for exam preparation only. Not medical advice and not a substitute for current product monographs, clinical guidelines or professional judgement. Questions have not yet been reviewed by a licensed pharmacist.