to the applicable purposes and conditions or indications of use (including warnings) published pursuant to subsection (i) or such labeling omits or fails to conform to other applicable information published pursuant to subsection (i);

(C) that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or

(D) that, based on a fair evaluation of all material facts, such labeling is false or misleading in any particular;

he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (D) do not apply, he shall issue an order approving the application. An order under this subsection approving an application with respect to an animal feed bearing or containing a new animal drug shall be effective only while there is in effect a regulation pursuant to subsection (i), on the basis of which such application (or a supplement thereto) was approved, relating to the use of such drug in or on such feed.

(4) (A) The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application with respect to any animal feed under this subsection if the Secretary finds

(i) that the application contains any untrue statement of a material fact; or

(ii) that the applicant has made any changes from the standpoint of safety or effectiveness beyond the variations provided for in the application unless he has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. The supplemental application shall be treated in the same manner as the original application.

If the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the health of man or of the animals for which such animal feed is intended, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence shall not be delegated.

(B) The Secretary may also, after due notice and opportunity for hearing to the applicant, issue an order withdrawing the approval of an application with respect

to any animal feed under this subsection if the Secretary finds

(i) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under paragraph (5) (A) of this subsection, or the applicant has refused to permit access to, or copying or verification of, such records as required by subparagraph (B) of such paragraph;

(ii) that on the basis of new information before him, evaluated together with the evidence before him when such application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein, and were not made adequate within a reasonable time after receipt of written notice from the Secretary, specifying the matter complained of; or

(iii) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such animal feed, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of.

(C) Any order under paragraph (4) of this subsection shall state the findings upon which it is based.

(5) In the case of any animal feed for which an approval of an application filed pursuant to this subsection is in effect

(A) the applicant shall establish and maintain such records, and make such reports to the Secretary, or (at the option of the Secretary) to the appropriate person or persons holding an approved application filed under subsection (b), as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or paragraph (4) of this subsection.

(B) every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such of

ficer or employee at all reasonable times to have access to and copy and verify such records.

(n) (1) The Secretary, pursuant to regulations promulgated by him, shall provide for the certification of batches of a new animal drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof. A batch of any such drug shall be certified if an approval of an application filed pursuant to subsection (b) is effective with respect to such drug and such drug has the characteristics of identity and such batch has the characteristics of strength, quality, and purity upon the basis of which the application was approved, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof.

(2) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this subsection, including provisions prescribing

(A) tests and methods of assay to determine compliance with applicable standards of identity and of strength, quality, and purity;

(B) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (C) administration and procedure; and

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(D) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service.

Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this subsection.

(3) Whenever, in the judgment of the Secretary, the requirements of this subsection with respect to any drug or class of drugs are not necessary to insure that such drug conforms to the standards of identity, strength, quality, and purity applicable thereto under paragraph (1) of this subsection, the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. The provisions of subsection (c) of section 507 of this Act (other than the first sentence thereof) shall apply under this paragraph.

(4) The Secretary shall promulgate regulations exempting from any requirement of this subsection

(A) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such

drugs comply with all such requirements upon removal from such establishments; and

(B) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed pursuant to this subsection and are intended for use in manufacturing other drugs.

(5) On petition of any interested person for the issuance, amendment, or repeal of any regulation contemplated by this subsection, the procedure shall be in accordance with subsection (f) of section 507 of this Act.

(6) Where any drug is subject to this subsection and not exempted therefrom by regulations, the compliance of such drug with sections 501(b) and 502(g) shall be determined by the application of the standards of strength, quality, and purity applicable under paragraph (1) of this subsection, the tests and methods of assay applicable under provisions of regulations referred to in paragraph (2) (A) of this subsection, and the requirements of packaging and labeling on the basis of which the application with respect to such drug filed under subsection (b) of this section was approved.

CHAPTER VI-COSMETICS

ADULTERATED COSMETICS

SEC. 601 [361]. A cosmetic shall be deemed to be adulterated

(a) 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 labeling 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 labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.

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

(c) 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.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 706 (a).

MISBRANDED COSMETICS

SEC. 602 [362]. A cosmetic shall be deemed to be misbranded

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. (c) If any word, statement, or other information required by or under authority of this act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If its container is so made, formed, or filled as to be misleading.

(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 706. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).

(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.

REGULATIONS MAKING EXEMPTIONS

SEC. 603 [363]. The Secretary shall promulgate regulations exempting from any labeling requirement of this act cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this act upon removal from such processing, labeling, or repacking establishment.