Regulatory standard

Sterility Testing for Compounded Medications

Test purpose; sample limitations; release; investigations; certificates; consumer interpretation.

What this standard actually requires

USP General Chapter 797 sets standards for compounding STERILE preparations — injections, infusions, ophthalmics.

Chapter 797 is the sterile counterpart to Chapter 795. It governs air quality classification, engineering controls such as ISO-classified cleanrooms, personnel garbing and competency, environmental monitoring, and sterility assurance.

It assigns beyond-use dates by risk category and by whether sterility testing was performed. Those dates are typically short — days to weeks — which is why a long-dated compounded sterile preparation warrants a question.

The 2012 New England Compounding Center outbreak, which killed dozens through contaminated steroid injections, is the event that drove both the DQSA and the strengthening of sterile compounding oversight.

Compliance is assessed by state boards for 503A pharmacies. For 503B outsourcing facilities, FDA assesses against CGMP, which subsumes and exceeds Chapter 797.

What is established about test purpose?

For compounded drug sterility testing, test purpose is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.

Where test purpose has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.

What is established about sample limitations?

For compounded drug sterility testing, sample limitations is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.

Where sample limitations has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.

What is established about release?

For compounded drug sterility testing, release is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.

Where release has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.

What is established about investigations?

For compounded drug sterility testing, investigations is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.

Where investigations has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.

What is established about certificates?

For compounded drug sterility testing, certificates is one of the elements this monitor tracks. The record that holds it is named in the source map below, and the verification state is shown in the snapshot above rather than asserted in prose.

Where certificates has not been checked against that source at this snapshot, the field renders Verification Pending. That is a statement about this platform's verification state and carries no implication about any entity.

What does this page establish?

It establishes the framework and the source map for compounded drug sterility testing, drawn from FDA primary sources verified on 2026-07-23. Framework facts — what the statute says, what registration means, which agency holds which record — are stable and checkable, and they are cited inline.

What it does not establish is any entity-specific fact. This platform separates those two categories deliberately, because they carry different verification burdens. A statutory definition can be cited once and relied on; a pharmacy's licence status changes continuously and must be checked at the moment of use.

Status terms on this page follow the platform's published status vocabulary.

Why compounded drug sterility testing is hard to verify

Three structural features of compounding oversight make verification harder than it looks, and they apply to this topic as much as any other.

First, authority is split. Federal and state regulators hold different records about the same entity, and neither register is complete on its own. Second, registration and inspection are separate events — a facility can be registered for years without an inspection, so a registration date tells you nothing about oversight intensity. Third, a record's currency is invisible without its date: a licence verified last year and a licence verified today look identical in a citation.

That is why every field on this platform carries a check date, and why a field without one renders as pending rather than as a fact.

Related records in this section

Section hub: Regulatory standards · Methodology · Status definitions · Right to respond

Sources

• FDA — Information for Outsourcing Facilities
• FDA — Q&A: Outsourcing Facility Registration
• FDA — Registered Outsourcing Facilities
• FDA — Aligning Federal and State Regulation of Compounders
• FDA — Outsourcing Facility Fees
• FDA — Compounded Drug Products That Are Essentially Copies
• FDA — Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List (30 Apr 2026)
• FDA — Registration of Human Drug Compounding Outsourcing Facilities (guidance)
• Nevada Board of Pharmacy — Notice of FDA Declaratory Orders (tirzepatide, semaglutide)
• FDA — Outsourcing Facility Fees guidance

Update history

Dates change only for substantive updates. Entities may submit a correction or response through the right-to-respond process.