21 CFR 801.110
§ 801.110 Retail exemption for prescription devices.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 801.110, § 801.110 Retail exemption for prescription devices, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88676
- Permanent ID
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.