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United States • Title 21 CFR • Part 357
This part of the CFR outlines the requirements for over-the-counter (OTC) drug products for human use that are not covered by other specific OTC drug regulations. It details the conditions for general recognition as safe and effective for specific miscellaneous internal drug products, including anthelmintics, cholecystokinetics, and internal deodorants.
(a) An over-the-counter anthelmintic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
As used in this subpart: Anthelmintic. An agent that is destructive to worms.
The active ingredient of the product is pyrantel pamoate when used within the dosage limits established in § 357.150(d)(1).
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “pinworm treatment.” Indication.(b) The labeling of the product states, under the heading “Indication,” the following: “For the treatment of pinworms.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) “Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” Directions.(d) The labeling of the product contains the following…
The labeling of the product contains a consumer package insert which includes the following information: (a) A discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be visually identified before taking this medication. (b) A detailed description of how to find and identify the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e) The appropriate labeling information contained in § 357.150 [51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan. 23, 1987]
The labeling provided to health professionals (but not to the general public) may contain an additional indication: “For the treatment of common roundworm infestation.”
(a) An over-the-counter cholecystokinetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart in addition to each of the general conditions established in § 330.1. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [48 FR 27005, June 10, 1983]
As used in this subpart: Cholecystokinetic drug product. A drug product that causes contraction of the gallbladder and is used during the course of diagnostic gallbladder studies (cholecystography). [48 FR 27005, June 10, 1983]
The active ingredient of the product consists of any of the following when used within the specified concentration and dosage form established for each ingredient: (a) 50-percent aqueous emulsion of corn oil. (b) Hydrogenated soybean oil in a suitable, water-dispersible powder. The hydrogenated soybean oil is food-grade, partially hydrogenated with a melting point of 41 to 43.5 °C, an iodine value of 65 to 69, and a fatty acid composition as follows: Table | Fatty acid | Percent composition | | --- | --- | | Myristic acid | 0.1 | | Palmitic acid | 10 | | Palmitoleic acid | 0.1 | | Stearic acid | 13.5 | | Oleic acid | 72 | | Linoleic acid | 3.8 | | Linolenic acid | 0.1 | | Arachidic acid | 0.5 | | Behenic acid | 0.2 | [54 FR 8321, Feb. 28, 1989]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “gallbladder diagnostic agent.” Indications.(b) The labeling of the product states, under the heading “Indications,” the following: “For the contraction of the gallbladder during diagnostic gallbladder studies.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) [Reserved] Directions.(d) The labeling of the product contains the following statements under the heading “Directions”: (1) “Take only when instructed by a doctor:” For products containing 50-percent aqueous emulsion of corn oil.(2) (i) “Shake well before using.” (ii) Oral dosage is 60 milliliters 20 minutes before diagnostic gallbladder x-ray or as directed by a…
Indication.The labeling provided to health professionals (but not to the general public) may contain the following information for ingredients identified in § 357.210: “For visualization of biliary ducts during cholecystography.” [54 FR 8321, Feb. 28, 1989]
(a) An over-the-counter deodorant drug product for internal use in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in § 330.1 of this chapter. (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
As used in this subpart: Colostomy.(a) An external operative opening of the colon. Deodorant for internal use.(b) An ingredient taken internally to reduce odors arising from conditions such as colostomies, ileostomies, or fecal incontinence. Ileostomy.(c) An external operative opening from the ileum. Incontinence.(d) An inability to retain urine or feces.
The active ingredient of the product consists of either of the following when used within the dosage limits established for each ingredient in § 357.850(d): (a) Bismuth subgallate. (b) Chlorophyllin copper complex.
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or ileostomy deodorant.” Indications.(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. For products containing bismuth subgallate identified in § 357.810(a).(1) “An aid to reduce odor from a colostomy or ileostomy.” For products containing chlorophyllin copper complex identified in § 357.810(b).(2) (i) “An aid to reduce odor from a colostomy or ileostomy.” (ii) “An aid to…
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