21 CFR § 205.4 - Wholesale drug distributor licensing requirement.

---
identifier: "/us/cfr/t21/s205.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 205.4 - Wholesale drug distributor licensing requirement."
title_number: 21
title_name: "Food and Drugs"
section_number: "205.4"
section_name: "Wholesale drug distributor licensing requirement."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "205"
part_name: "GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS"
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. 351, 352, 353, 371, 374."
regulatory_source: "55 FR 38023, Sept. 14, 1990, unless otherwise noted."
cfr_part: "205"
---


# 205.4 Wholesale drug distributor licensing requirement.

Every wholesale distributor in a State who engages in wholesale distributions of prescription drugs in interstate commerce must be licensed by the State licensing authority in accordance with this part before engaging in wholesale distributions of prescription drugs in interstate commerce.