Part 349 — Ophthalmic Drug Products for Over-the-Counter Human Use
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.
Sections
- § 349.1 Scope.
- § 349.3 Definitions.
- § 349.10 Ophthalmic astringent.
- § 349.12 Ophthalmic demulcents.
- § 349.14 Ophthalmic emollients.
- § 349.16 Ophthalmic hypertonicity agent.
- § 349.18 Ophthalmic vasoconstrictors.
- § 349.20 Eyewashes.
- § 349.30 Permitted combinations of active ingredients.
- § 349.50 Labeling of ophthalmic drug products.
- § 349.55 Labeling of ophthalmic astringent drug products.
- § 349.60 Labeling of ophthalmic demulcent drug products.
- § 349.65 Labeling of ophthalmic emollient drug products.
- § 349.70 Labeling of ophthalmic hypertonicity drug products.
- § 349.75 Labeling of ophthalmic vasoconstrictor drug products.
- § 349.78 Labeling of eyewash drug products.
- § 349.79 Labeling of permitted combinations of active ingredients.
- § 349.80 Professional labeling.