CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR349]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 349 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart A - General Provisions

Sec. 349.1 Scope.

(a) An over-the-counter ophthalmic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 349.3 Definitions.

As used in this part:

(a) Ophthalmic drug product. A drug product, which should be sterile in accordance with § 200.50, to be applied to the eyelid or instilled in the eye.

(b) Astringent. A locally acting pharmacologic agent which, by precipitating protein, helps to clear mucus from the outer surface of the eye.

(c) Buffering agent. A substance which stabilizes the pH of solutions against changes produced by introduction of acids or bases from such sources as drugs, body fluids, tears, etc.

(d) Demulcent. An agent, usually a water-soluble polymer, which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation.

(e) Emollient. An agent, usually a fat or oil, which is applied locally to eyelids to protect or soften tissues and to prevent drying and cracking.

(f) Eyewash, eye lotion, irrigating solution. A sterile aqueous solution intended for washing, bathing, or flushing the eye.

(g) Hypertonicity agent. An agent which exerts an osmotic gradient greater than that present in body tissues and fluids, so that water is drawn from the body tissues and fluids across semipermeable membranes. Applied topically to the eye, a hypertonicity agent creates an osmotic gradient which draws water out of the cornea.

(h) Isotonicity. A state or quality in which the osmotic pressure in two fluids is equal.

(i) Vasoconstrictor. A pharmacologic agent which, when applied topically to the mucous membranes of the eye, causes transient constriction of conjunctival blood vessels.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.