GLOSSARY

Regulatory and evidence terms.

Clinical trial phase

A research-stage label that describes how a human trial is organized; it is not the same as approval.

Compounded drug

A patient-specific or outsourcing-facility drug preparation pathway; compounded products are generally not FDA-approved.

DMF

A Drug Master File is a confidential manufacturing or quality submission to FDA. A DMF is not a product approval.

Evidence grade

A compact rating of how strong the support is, from approved-label and strong human evidence to unsupported or high-risk claims.

FDA-approved

An FDA approval means a specific product has been reviewed for a labeled use; it does not automatically apply to all products using a similar ingredient.

NDC listing

National Drug Code listing identifies marketed drug products, but listing alone should not be confused with FDA approval.

Research use only

A label for laboratory research materials; it does not make a product appropriate for human use.