USP & Facility Standards

USP-native compounding — <795>, <797> and <800> enforced as rules for 503A pharmacies

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Standards as code, not paperwork
Every limit below is computed and enforced at the point of work — a lot's BUD is auto-capped to the USP maximum, a hazardous lot won't start without containment, and a sterile lot is dated by its Category.
This facility 503A Compounding Pharmacy

State-licensed; patient-specific prescriptions required. BUDs per USP <795>/<797>; only limited anticipatory compounding.

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Patient-specific RxState-licensed (503A)USP <795>/<797>/<800> enforced
USP <795>
Nonsterile compounding
  • BUD ceilings: aqueous 14 days, nonaqueous 180 days
  • Category & water-activity-aware dating
  • Master Formulation Records + ingredient QC
USP <797>
Sterile compounding
  • Category 1/2/3 BUDs by storage + sterility testing
  • ISO-classified environment & garbing
  • Assay/endotoxin gates before release
USP <800>
Hazardous drugs
  • C-PEC in a negative-pressure ISO 7 room, externally vented
  • PPE + closed-system transfer devices (CSTD)
  • Containment verified before a hazardous lot can start
Live BUD calculator
Maximum BUD
14 days
USP <795>: aqueous (Aw ≥0.6) — 14 days, refrigerated
USP <795>
503A — traditional, patient-specific compounding

1QRx applies the 503A rule set: patient-specific prescriptions, USP <795>/<797>/<800> BUD & containment enforcement, and only limited anticipatory compounding. 503B outsourcing (FDA-registered, cGMP, batch production) is out of scope.

USP chapters enforced
795 · 797 · 800
Facility model
503A
patient-specific
BUD enforcement
Auto-capped
at lot creation