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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.

Title 21

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Subpart A - General Provisions
§ 341.1 Scope.

(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or 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.

[51 FR 35339, Oct. 2, 1986]

§ 341.3 Definitions.

As used in this part:

(a) Bronchodilator drug. A drug used to overcome spasms that cause narrowing of the bronchial air tubes, such as in the symptomatic treatment of the wheezing and shortness of breath of asthma.

(b) Oral antitussive drug. A drug that either is taken by mouth or is dissolved in the mouth in the form of a lozenge and acts systemically to relieve cough.

(c) Topical antitussive drug. A drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer, or when dissolved in the mouth in the form of a lozenge for a local effect.

(d) Expectorant drug. A drug taken orally to promote or facilitate the removal of secretions from the respiratory airways.

(e) Antihistamine drug. A drug used for the relief of the symptoms of hay fever and upper respiratory allergies (allergic rhinitis).

(f) Oral nasal decongestant drug. A drug that is taken by mouth and acts systemically to reduce nasal congestion caused by acute or chronic rhinitis.

(g) Topical nasal decongestant drug. A drug that when applied topically inside the nose, in the form of drops, jellies, or sprays, or when inhaled intranasally reduces nasal congestion caused by acute or chronic rhinitis.

(h) Calibrated dropper. A dropper calibrated such that the volume error incurred in measuring any liquid does not exceed 15 percent under normal use conditions.

(i) Effervescent dosage form. A dosage form intended to be dissolved in water before administration. It contains, in addition to the active ingredient(s), mixtures of acids (citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water.

[51 FR 35339, Oct. 2, 1986, as amended at 54 FR 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 1994; 71 FR 43362, Aug. 1, 2006]