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  • PART I ADMINISTRATION OF THE GOVERNMENT
  • TITLE XV REGULATION OF TRADE
  • CHAPTER 94 INSPECTION AND SALE OF FOOD, DRUGS AND VARIOUS ARTICLES
  • Section 186 Adulteration of drugs, foods, cosmetics and devices defined

Section 186. For the purposes of this chapter, an article shall be deemed to be adulterated:—

In the case of a drug: First, if a drug sold under or by a name recognized in any official compendium differs from the standards of strength, quality or purity as determined by the test, if any, laid down in such official compendium at the time of investigation; provided, that no drug defined in an official compendium shall be deemed to be adulterated hereunder if the standard of strength, quality or purity thereof is plainly stated upon the bottle, box or other container thereof delivered to the customer, although such standard may differ from that determined by the test, if any, laid down in the official compendium.

For the purposes of sections one hundred and eighty-six to one hundred and ninety-five, inclusive, the term “official compendium” shall mean the official United States pharmacopoeia, the official homeopathic pharmacopoeia of the United States, the official national formulary, or any supplement to any of them. For the purposes of these sections the term “drug” shall also mean and include all medicines, preparations, substances and mixtures of substances intended to affect the structure or any function of the body of man or other animals.

Second, if its strength or purity falls below the professed standard or quality under which it is sold.

Third, if it consists in whole or in part of any filthy, putrid or decomposed substance.

Fourth, if it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health.

Fifth, if it bears or contains, for purposes of coloring only, a coal tar color other than one from a batch which has been certified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act and amendments thereto.

Sixth, if any substance has been mixed or packed therewith so as to reduce its strength, quality or purity, or if any substance has been substituted wholly or in part therefor.

In the case of food: First, if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

Second, (1) if it bears or contains, by reason of administration of any substance to the livestock or poultry or otherwise, any added poisonous or added deleterious substance;

(2) if it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug and Cosmetic Act;

(3) if it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug and Cosmetic Act;

(4) if it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug and Cosmetic Act; provided that an article which is not otherwise deemed adulterated under clause (2), (3) or (4) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by regulations of the department;

Third, if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthy, unwholesome or otherwise unfit for food;

Fourth, if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

Fifth, if it is, in whole or in part, the product of an animal, including poultry, which has died otherwise than by slaughtering;

Sixth, if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

Seventh, if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug and Cosmetic Act;

Eighth, if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or

Ninth, if it is margarine containing animal fat and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance; or

Tenth, if it falls below the standard of purity, quality or strength which it purports or is represented to possess.

In the case of a cosmetic: First, if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the label thereof, or under such conditions of use as are customary or usual: Provided, That this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows: to do so may cause blindness”, and the label of which bears adequate directions for such preliminary testing. For the purposes of this paragraph, the word “label” shall include all written, printed or graphic matter upon any cosmetic article or any of its containers or wrappers or accompanying such article and, for the purposes of this paragraph and paragraph “Fifth” below, the words “hair dye” shall not include eyelash dyes or eyebrow dyes.

Second, if it consists in whole or in part of any filthy, putrid, or decomposed substance.

Third, if it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Fourth, if its container is composed, in whole or in part, of any poisonous or deleterious substance, which may render the contents injurious to health.

Fifth, if it is not a hair dye and it bears or contains a color other than one which has been approved for such use under the authority of the federal food, drug and cosmetic act and amendments thereto, with such restrictions as the food and drug administration of the United States has placed upon such use.

In the case of a device: First, if it consists in whole or in part of any filthy, putrid or decomposed substance.

Second, if it is prepared or held under insanitary conditions whereby it may be contaminated with filth or rendered injurious to health.

Third, if it bears or contains for purposes of coloring a color additive other than one which has been listed and certified in accordance with amended FDC Act Sec. 706(b).

Fourth, if it is packed under insanitary conditions whereby it may be contaminated with filth or rendered injurious to health.

Fifth, if the container thereof is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.