# FDA Form 2253

> Form 2253 is the FDA submission that accompanies pharmaceutical promotional materials at time of first use — every promotional piece for a prescription drug is filed with OPDP on this form.

> **FDA Form 2253** ("Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use") is the form under which US prescription-drug promotional materials are submitted to FDA at **time of first use**. Each promotional piece — sales aid, website, e-detail, TV spot — is filed with the agency's Office of Prescription Drug Promotion ([OPDP](/glossary/opdp/)) along with the material itself and its references.

Two properties shape the workflow around it. First, 2253 submission is *notification at use*, not pre-approval — FDA generally sees material as it launches (pre-clearance applies mainly to specific cases such as certain accelerated-approval products). Enforcement is post-hoc, via OPDP untitled and warning letters. Second, the filing must be complete and internally consistent — final approved material, annotated references, current labeling — which makes the 2253 package the downstream artifact of a clean [MLR review](/glossary/mlr-review/): everything the committee verified is what gets filed.

The UK has **no direct analog**: material is gated instead by pre-use [certification](/glossary/copy-approval/) under the ABPI Code, with complaint-driven enforcement through the PMCPA. Teams operating in both markets file 2253s in the US and rely on the signatory gate in the UK.

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Source: https://medcom.claims/glossary/fda-form-2253/ · Updated 2026-07-13 · © Mantir, Inc.