Compounding: Sterile and Nonsterile Preparations
Two rulebooks, one license
Nonsterile compounding follows USP <795>; sterile compounding follows USP <797>; hazardous drug handling follows USP <800>. Connecticut expects compliance with these standards as a condition of licensure, and inspection questions frequently ask who may compound what, where, and with what documentation.
503A versus 503B
A 503A pharmacy compounds patient-specific prescriptions pursuant to a valid prescription, may use bulk drug substances only under the applicable FDA framework, and may not mass-produce copies of commercially available products. A 503B outsourcing facility compounds under different rules - current good manufacturing practice, adverse event reporting, and a different bulk substance pathway. Confusing the two is a classic distractor.
Documentation
Nonsterile: master formulation record, compounding record per preparation, component sources and lot numbers, beyond-use date rationale, and a stability basis. Sterile: everything above plus environmental monitoring, personnel training and qualification, garbing and hand hygiene observation, cleaning and disinfection logs, and direct and end-product testing where required.
Beyond-use dates
A BUD is assigned at the time of compounding, based on the risk level of the preparation, the storage temperature, and whether sterility testing was performed. It is printed on the label along with the time, storage conditions, and route of administration.
Traps
- Extending a BUD for convenience or because the preparation "looks fine."
- Using a nonsterile component in a sterile preparation without justification.
- Omitting the BUD time, not just the date, from a sterile label.
- Assuming a 503A pharmacy may build anticipatory stock of sterile products.
Rule of thumb: the BUD clock starts when compounding begins and is set by risk level and storage temperature - never by scheduling pressure.
Worked example: a pharmacy wants a longer refrigerated BUD than the standard table allows. Without validated stability data or a qualified method, the answer is no; the standard BUD applies.