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1 TO BEAR PLAINLY AND CONSPICUOUSLY

2 ADEQUATE DIRECTIONS FOR SUCH USE, AND

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WHEN USED AS INDICATED, IT FAILS TO 4 PREVENT THE GROWTH OF MICRO ORGAN 5 ISMS WITHIN THE ENTIRE TIME OF SUCH USE 6 WHEN TESTED BY A METHOD PRESCRIBED 7 BY REGULATIONS AS PROVIDED BY SEC8 TIONS 701 AND 703: PROVIDED, THAT NO DRUG SHALL BE DEEMED TO BE MISBRANDED 10 UNDER THIS PARAGRAPH BY REASON OF 11 FAILURE OF ITS LABELING TO BEAR ADE 12 QUATE DIRECTIONS FOR A USE INDICATED IN ADVERTISING DISSEMINATED ONLY TO 14 MEMBERS OF THE MEDICAL AND PHARMA CEUTICAL PROFESSION, OR APPEARS ONLY IN SCIENTIFIC PUBLICATIONS OF THESE

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PROFESSIONS.

(K) WHEN CONSTRUING AND ENFORC19 ING THE PROVISIONS OF THIS ACT WITH RESPECT TO LABELING AND ADVERTISEMENTS. THE TERM "ANTISEPTIC" SHALL BE DEEMED TO HAVE THE SAME MEANING AS

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THE WORD GERMICIDE", EXCEPT, HOW24 EVER, IN THE CASE OF A DRUG PURPORTING TO BE. OR REPRESENTED AS AN ANTISEPTIC

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1 FOR INHIBITORY USE AS A WET DRESSING, 2 OINTMENT, DUSTING POWDER, OR SUCH

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OTHER USE AS INVOLVES PROLONGED CON

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TACT WITH THE BODY.

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(1) The Secretary is hereby authorized directed to pro6 mulgate regulations exempting from any labeling or packag

7 ing requirement of this Act drugs AND DEVICES which

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are, in accordance with the practice of the trade, processed, 9 labeled, or repacked in substantial quantities at establishments other than those where originally processed or 11 packed, on condition that such drugs AND DEVICES

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are in conformity with the provisions of this Act upon removal from such processing, labeling, or repacking

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establishment.

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CERTIFICATION OF COAL-TAR COLORS FOR DRUGS

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SEC. 403. The Secretary is hereby authorized to 17 promulgate regulations, as provided by sections 701 and 703, 18 for the certification of coal-tar colors which for purposes of 19 coloring only are harmless and suitable for use in drugs.

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CHAPTER V

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ADULTERATED COSMETICS

SECTION 501. A cosmetic shall be deemed to be

23 adulterated—

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(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to the user

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health UNDER THE CONDITIONS OF USE PRE

2 SCRIBED IN THE LABELING OR ADVERTISING

3 THEREOF, OR under such conditions of use as are cus4 tomary or usual.

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(b) If it bears or contains any poisonous or deleteri

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ous substance prohibited, or in excess of the limits of tol

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erance prescribed, by regulations as provided by sections 8 503, 701, and 703.

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(b) If it consists in whole or in part of any filthy, 10 putrid, or decomposed substance.

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(c) If it has been prepared, packed, or held under in12 sanitary conditions whereby it may have become contaminated

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with filth, or whereby it may have been rendered in14 jurious to health.

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(d) If its container is composed of any poisonous or 16 deleterious substance which may render it injurious to

17 health.

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(e) If it contains a coul-tar color other than one from

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a batch that has been certified in accordance with regulations

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as provided by sections 503, 701, and 703.

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MISBRANDED COSMETICS

SEC. 502. A cosmetic shall be deemed to be

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misbranded

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(a) If its labeling is false or misleading in any par25 ticular, OR IF IT IS INJURIOUS TO HEALTH

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UNDER THE CONDITIONS OF USE PRE

2 SCRIBED IN THE LABELING OR ADVERTISING

3 THEREOF.

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(b) If in package form it fails to bear a label contain5 ing (1) the name and place of business of the manufac

6 turer, packer, seller, or distributor; and (2) an accurate

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statement of the quantity of the contents in terms of weight, 8 measure, or numerical count: Provided, That under subdivi

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9 sion (2) of this paragraph reasonable variations shall be 10 permitted, and exemptions as to small packages shall be 11 established, by regulations prescribed by the Secretary. (c) If any word, statement, or other information 13 required on the label to avoid adulteration or misbranding 14 under any provision of this Act is not prominently placed 15 thereon in such a manner as to be easily seen and in such terms as to be readily intelligible to understood by the pur17 chasers and users of such articles under customary condi

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tions of purchase and use, due consideration being given to 19 the size of the package.

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(d) The Secretary is hereby authorized to promulgate 21 regulations exempting from any labeling or packaging 22 requirement of this Act cosmetics which are, in accordance 23 with the practice of the trade, processed, labeled, or repacked 24 in substantial quantities at establishments other than those where originally processed or packed, on condition that such

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1 cosmetics are in conformity with the provisions of this Act

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upon removal from such processing, labeling, or repacking establishment.

TOLERANCES FOR POISONOUS INGREDIENTS IN COSMETICS

SEC. 503. (a) If a poisonous or deleterious substance

6 in eosmeties is or may be injurious to health, the Secretary

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is hereby authorized to promulgate regulations, as provided

8 by sections 701 and 703, prohibiting such substance in

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or on any cosmetie, or establishing tolerances limiting the 10 amount therein or thereon, for the protection of publie

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health, taking into account the extent to which the use of such substance is required in the production of such cos metie and the other ways in which the consumer may be

affeeted by the same or other poisonous or deleterious substances.

CERTIFICATION OF COAL-TAR COLORS FOR COSMETICS

SEC. 503. The Secretary is hereby authorized to pro18 mulgate regulations, as provided by sections 701 and 703, 19 for the certification of coal-tar colors which are harmless and 20 suitable for use in cosmetics.

CHAPTER VI

FALSE ADVERTISEMENT

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SECTION 601. (a) An advertisement of a food, drug,

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DEVICE, or cosmetic shall be deemed to be false if it is

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false or misleading in any particular relevant to the purposes

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