21 CFR § 349.80 - Professional labeling.

---
identifier: "/us/cfr/t21/s349.80"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 349.80 - Professional labeling."
title_number: 21
title_name: "Food and Drugs"
section_number: "349.80"
section_name: "Professional labeling."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "349"
part_name: "OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
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, 351, 352, 353, 355, 360, 371."
regulatory_source: "53 FR 7090, Mar. 4, 1988, unless otherwise noted."
cfr_part: "349"
---


# 349.80 Professional labeling.

The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but not to the general public) may contain instructions for the use of these products in professional eye examinations (*i.e.*, gonioscopy, electroretinography).