Compounding, Sterile and Non-Sterile Preparation, and Quality Assurance
Standards adopted
New Mexico expects compliance with the USP compounding chapters as incorporated by Board rule: USP 795 for non-sterile, USP 797 for sterile, and USP 800 for hazardous drugs. Compounding also requires a prescription for an identified patient (or a documented anticipatory/protocol basis where allowed) and may not be simple copying of a commercially available product.
Non-sterile (795)
Assess components, use a master formulation record and a compounding record, assign a beyond-use date from the chapter's table based on water activity and preservative status, and perform release checks. BUDs default to short intervals unless stability is supported; maximum BUDs for typical aqueous preserved preparations are on the order of months, not years.
Sterile (797)
Designated cleanroom spaces: an ISO 5 primary engineering control inside an ISO 7 buffer, with an ISO 8 ante area; environmental monitoring, personnel qualification, garbing, media fill and fingertip testing, and documented cleaning. Category 1 CSPs made from commercial sterile products and stored at controlled room temperature carry a 12-hour BUD (24 hours refrigerated); Category 2 gives 4 days at room temperature; Category 3 extends further. Hazardous drugs require negative-pressure rooms, closed-system transfer devices, and containment segregated from non-hazardous work.
Traps and worked example
The classic trap is assigning a manufacturer's expiration date to a compounded preparation - beyond-use dating follows the chapter, not the components. Worked rule: vancomycin eye drops compounded aseptically from a commercial vial in an ISO 5 hood, stored at room temperature, are Category 1 - default 12-hour BUD unless a documented stability study justifies more.