21 CFR § 801.110 - Retail exemption for prescription devices.

---
identifier: "/us/cfr/t21/s801.110"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.110 - Retail exemption for prescription devices."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.110"
section_name: "Retail exemption for prescription devices."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "801"
part_name: "LABELING"
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, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.110 Retail exemption for prescription devices.

A device subject to § 801.109 shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f)(1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.