Non-sterile compounding

Non-sterile compounding covers dosage forms taken by mouth, applied to skin, or given rectally or vaginally, where sterility is not required. Pharmacies compound when a commercial product will not work for a patient: a child who needs a liquid version of a tablet-only drug, a patient allergic to a dye or preservative, a strength that is not manufactured, or a flavored formulation a patient will actually take. The governing standard is USP <795>, which sits alongside USP <797> for sterile preparations and USP <800> for hazardous drugs.

The workflow is procedural and documented at every step. The technician verifies the formula and the calculations, selects USP or NF grade ingredients, checks each component's lot number and expiration, weighs and measures with calibrated equipment, and combines the ingredients using the appropriate technique — trituration for particle size reduction, geometric dilution for uniform mixing of a small quantity of active drug into a larger base, levigation with a small amount of liquid to make a smooth paste, and spatulation for blending semisolids.

Documentation and labeling close the loop. A master formulation record describes how the preparation is made, and a compounding record documents each batch actually prepared, including ingredients, lots, quantities, the person who compounded it, and the person who checked it. The label carries a beyond-use date rather than a manufacturer expiration date, assigned according to the dosage form and USP <795> criteria. A designated compounding area, appropriate garb, cleaned equipment, and final verification by the pharmacist are required throughout.

The PTCE tests this material in the order entry and processing domain. Expect questions on which USP chapter applies, the mixing techniques and when to use each, master formulation and compounding record requirements, beyond-use dating, and the calculations behind preparing a specific strength or quantity.