PEBC MCQ study guide: Sterile & Non-Sterile Compounding (NAPRA Standards)

Providing Care – Distribution

NAPRA Model Standards, Master Formulation Records, Beyond-Use Dates, and cleanroom garbing.

NAPRA Model Standards Framework

NAPRA's Model Standards for Pharmacy Compounding classify compounding by risk level rather than treating all compounding as one activity:

Non-sterile compounding: simple (e.g., reconstituting/mixing commercially available products with minimal manipulation), moderate, and complex categories, each with escalating documentation, training, and facility requirements.
Sterile compounding: risk levels are categorized (analogous in spirit to USP <797>'s low/medium/high-risk categories) based on the number of sterile product manipulations, the compounding environment, and whether non-sterile starting components are involved — risk level determines the required beyond-use date limits and environmental controls (ISO-classified cleanroom, laminar airflow, personnel garbing/gowning procedures, and viable/non-viable particle monitoring).

Every compounded preparation requires a Master Formulation Record (MFR — the master "recipe," including ingredients, equipment, method, stability/BUD justification) and a Compounding Record (the specific batch/patient-specific log documenting what was actually made, by whom, and when) — these are two distinct, both-mandatory documents, a frequently tested distinction.

Beyond-Use Dating (BUD)

BUD is distinct from a manufacturer's expiry date — BUD is assigned by the compounder based on formulation-specific stability data (or, absent specific data, conservative default limits) and is always equal to or shorter than the shortest ingredient's expiry, never longer.

General conservative default BUD principles (used when product-specific stability data is unavailable) — commonly tested defaults:

Non-aqueous formulations (e.g., oral powders, some ointments): longer default BUD (often up to 6 months, or per the source ingredient's remaining expiry if shorter)
Water-containing (aqueous) oral formulations: much shorter default BUD (commonly ~14 days refrigerated) because water supports microbial growth
Sterile preparations: BUD is driven primarily by the assigned sterile compounding risk level and storage temperature (room temp vs. refrigerated vs. frozen), with low-risk-level preparations getting the shortest room-temperature BUDs and progressively longer BUDs when refrigerated/frozen.

The exam expects the PRINCIPLE (aqueous = shorter, driven by microbial growth risk; BUD ≤ shortest ingredient expiry; sterile risk level drives BUD) more than memorized exact day-counts, since exact NAPRA reference tables are looked up in practice, not memorized number-for-number.

Cleanroom Garbing & Environment (Sterile Compounding)

Proper garbing order for sterile compounding generally proceeds from "dirtiest to cleanest": hair/beard cover and shoe covers first, then mask, then hand hygiene, then non-shedding gown, then final hand antisepsis/sterile gloving immediately before entering the primary engineering control (the laminar airflow workbench/biological safety cabinet). Hand hygiene is performed both before donning garb and again immediately before gloving.

Hazardous sterile compounding (chemotherapy and other hazardous drugs) requires additional controls per NIOSH/USP <800>-aligned Canadian guidance: a Biological Safety Cabinet or Compounding Aseptic Containment Isolator (negative pressure, externally vented), closed-system transfer devices where applicable, and double gloving with chemotherapy-rated gloves.

High-yield points

Master Formulation Record (the recipe) and Compounding Record (the batch log) are two distinct, both-mandatory documents.
BUD is compounder-assigned and stability-based — always ≤ the shortest ingredient's expiry, never longer, and never the same as a manufacturer expiry date.
Aqueous (water-containing) oral compounds get much shorter default BUDs than non-aqueous ones — microbial growth risk is the driver.
Garbing order: dirtiest to cleanest (hair/shoe covers → mask → hand hygiene → gown → final antisepsis/sterile gloving immediately before the LAFW).

Guideline references

NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations
NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations