Small quantity depends on the risk assessment for each API which should include an assessment of frequency of compounding with these ingredients. As per the guidance document Section 4.1, some factors to consider in the risk assessment include the:
- complexity of compounding the preparation;
- need for verification and uninterrupted workflow;
- frequency of compounding high-risk or low-risk preparations;
- risk of cross-contamination with other products (e.g., allergens);
- concentration of ingredients in the preparation;
- quantity of ingredients being handled;
- physical characteristics of ingredients (e.g., liquid vs. solid vs. powders, or water-soluble vs. lipid-soluble);
- education and competency of compounding personnel;
- availability of appropriate facilities and equipment;
- classification of ingredients if identified by WHMIS as presenting a health hazard, or a drug classified by NIOSH as hazardous (see reference to NIOSH in section 4.3);
- type of hazardous drug (e.g., anti-neoplastic, non-antineoplastic, reproductive risk only);
- exposure to compounding personnel for each preparation and accumulation of exposure over time; and
- risk of microbial contamination (liquids, creams, and ointments may be particularly susceptible to microbial and other contamination).
The risk assessment must be reviewed on a continuum to identify and mitigate risk, thereby providing quality assurance.
A decision algorithm to assist in determining requirements for non-sterile compounding can be found in section 4.2.
Note: Occasional small quantities of materials must not be considered in isolation. If several different high-risk or low-risk preparations are being compounded, the cumulative risk must be considered even if they are compounded on different days. This must be documented in the risk assessment. Registrants must make available an environment and equipment that ensures the safety of pharmacy personnel when evaluating level of risk. If there is uncertainty as to the level of risk, then the registrant shall defer to the higher standard.