21 CFR § 207.45 - When, after initial registration of an establishment, must drug listing information be submitted?

---
identifier: "/us/cfr/t21/s207.45"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 207.45 - When, after initial registration of an establishment, must drug listing information be submitted?"
title_number: 21
title_name: "Food and Drugs"
section_number: "207.45"
section_name: "When, after initial registration of an establishment, must drug listing information be submitted?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "207"
part_name: "REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "81 FR 60212, Aug. 31, 2016, unless otherwise noted."
cfr_part: "207"
---


# 207.45 When, after initial registration of an establishment, must drug listing information be submitted?

For each drug being manufactured, repacked, relabeled, or salvaged for commercial distribution at an establishment at the time of initial registration, drug listing information must be submitted no later than 3 calendar days after the initial registration of the establishment.