When does Category 1 compounding elevate to Category 2?

In the context of compounding in pharmacies, elevating from Category 1 to Category 2 typically involves a change that increases the complexity or risk associated with the preparation of the medication. Category 1 compounding generally refers to preparations that are low-risk and often consist of simple mixing or reconstituting of commercially available products without significant modification.

When compounding requires altering the original dosage form, it usually indicates a higher level of complexity and requires a greater understanding of pharmaceutical principles to ensure the safety and effectiveness of the compounded product. Altering a dosage form could involve changing a solid to a liquid, or creating a modified-release product, both of which can introduce variables that need to be carefully managed to ensure patient safety.

In contrast, factors such as whether it involves veterinary prescriptions, the number of active ingredients, or the need for patient counseling relate to specific scopes, requirements, or regulations of compounding but do not inherently change the risk classification from Category 1 to Category 2 based on the complexity of the compounding process itself.