Compounding Pharmacies
Sterile and non-sterile compounders (503A/503B outsourcing facilities) — applying USP compounding standards and, for outsourcing facilities, cGMP expectations.
What this page does not claim
A sector is an organization’s role in the value chain, not a legal category. SPEQ maps the disciplines and standards that role typically operates under; it does not determine which apply to your organization, and a count of decoded standards measures SPEQ’s coverage.
WHAT THIS SECTOR DOES
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.
REGULATORY LANDSCAPE
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.
THE OVERSIGHT MODEL
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.
WHAT QUALITY MEANS HERE
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.
STANDARDS SPEQ DECODES · 161
Open the full library →WHERE QUALITY FAILS
- 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
KEY REGULATORY BODIES
Derived from the 161 standards SPEQ decodes for this sector.
GXP DISCIPLINES IN THIS SECTOR
Compounding Pharmacies: frequently asked questions
Reference answers on what a compounding pharmacies does, what governs it, and who is accountable for quality.
What is the difference between a 503A pharmacy and a 503B outsourcing facility?
Under the FD&C Act, a 503A pharmacy compounds patient-specific preparations against individual prescriptions and is overseen primarily by its state board of pharmacy. A 503B outsourcing facility voluntarily registers with FDA, follows cGMP, and accepts FDA inspection in exchange for being able to compound at scale without patient-specific prescriptions.
What are USP <795>, <797>, and <800>?
They are the USP compounding chapters that govern practice: <795> covers non-sterile compounding, <797> covers sterile compounding (cleanroom classification, aseptic technique, beyond-use dating, environmental monitoring), and <800> covers the handling of hazardous drugs (containment, ventilation, personnel protection). They are enforced through state boards of pharmacy.
Do compounding pharmacies have to follow cGMP?
It depends on the track. A traditional 503A pharmacy works to USP standards under its state board, not full drug-product cGMP. A 503B outsourcing facility must operate a genuine cGMP quality system — process validation, stability, and release testing — as applied by FDA under 21 CFR 210/211, not pharmacy practice scaled up.