Status methodology

Our status assertions are structured so you can see the activity, jurisdiction, status, as-of date, qualification, and controlling source for every claim.

Activity

The regulated activity (e.g., FDA-approved drug product, 503A compounding, 503B outsourcing, national drug shortage, sport rule).

Status value and label

The status value is a controlled category used for color-coding and filtering. The status label is the human-readable phrase shown on the page.

As-of date

The date the controlling source took effect or was last updated. This is not necessarily the date we reviewed the record.

Qualification

A short explanation of what the status means, including route, indication, or scope limits.

Confidence

High confidence means a clear controlling source. Medium or low confidence means interpretation, pending action, or incomplete information.

Supersession

If an assertion is replaced by a newer assertion, the older one is marked superseded and the newer one is shown.