Code of Federal Regulations · Section
§ 349.80 — Professional Labeling
21 C.F.R. § 349.80
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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).
Authorizing Statute
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Definitions; generally21 U.S.C. § 321