Compounding Pharmacies
Sterile and non-sterile compounders (503A/503B outsourcing facilities) — applying USP compounding standards and, for outsourcing facilities, cGMP expectations.
Compounding pharmacies prepare patient-specific and batch medicines that are not commercially available — from simple non-sterile preparations to high-risk sterile compounds. They operate along a spectrum from traditional 503A pharmacies dispensing on individual prescriptions to 503B outsourcing facilities that compound at scale and register with the FDA under cGMP.
Practice is governed by the USP compounding chapters — <795> (non-sterile), <797> (sterile), and <800> (hazardous drugs) — under state boards of pharmacy. Sections 503A and 503B of the FD&C Act define the two regulatory tracks; 503B outsourcing facilities additionally follow cGMP (21 CFR 210/211 as applied by FDA) and are subject to FDA inspection.
A 503A pharmacy compounds for an identified patient under a prescription and is overseen primarily by its state board against USP standards; a 503B outsourcing facility voluntarily registers with FDA, follows cGMP, and accepts FDA inspection in exchange for compounding without patient-specific prescriptions. Knowing which track a preparation falls under — and holding the corresponding quality bar — is the defining decision.
Sterile compounding under USP <797>
Cleanroom classification, aseptic technique, beyond-use dating, and environmental monitoring for sterile preparations — the highest-risk compounding activity.
Hazardous-drug handling (USP <800>)
Containment, ventilation, and personnel protection for hazardous drug preparation, protecting both product and practitioner.
503A vs 503B track control
Correctly classifying each preparation and applying the right regulatory bar — prescription-based practice versus cGMP outsourcing.
cGMP for outsourcing facilities
For 503B facilities, a genuine cGMP quality system — process validation, stability, and release testing — not pharmacy practice scaled up.
- ›Sterility failures from poor aseptic technique or cleanroom control
- ›Beyond-use dating unsupported by stability or sterility data
- ›Operating at 503B scale without a real cGMP quality system
- ›Inadequate containment for hazardous-drug compounding
Derived from the 79 standards SPEQ decodes for this sector.
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