82 STAT. 348

52 Stat. 1046. 21 USC 342. Recordkeeping.

cations of use prescribed pursuant to subsection (i)), be considered adulterated within the meaning of clause (1) of section 402(a).

"(1) (1) In the case of any new animal drug for which an approval of an application filed pursuant to subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, or with respect to animal feeds bearing or containing such drug, 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 subsection (m) (4) of this section. Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary.

"(2) 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 officer or employee at all reasonable times to have access to and copy and verify such records.

(m) (1) Any person may file with the Secretary an application with respect to any intended use or uses of an animal feed bearing or containing a new animal drug. Such person shall submit to the Secretary as part of the application (A) a full statement of the composition of such animal feed, (B) an identification of the regulation or regulations (relating to the new animal drug or drugs to be used in such feed), published pursuant to subsection (i), on which he relies as a basis for approval of his application with respect to the use of such drug in such feed, (C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed, (D) specimens of the labeling proposed to be used for such animal feed, and (E) if so requested by the Secretary, samples of such animal feed or components thereof.

"(2) Within ninety days after the filing of an application pursuant to subsection (m) (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (A) issue an order approving the application if he then finds that none of the grounds for denying approval specified in paragraph (3) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under paragraph (3) on the question whether such application is approvable. The procedure governing such a hearing shall be the procedure set forth in the last two sentences of subsection (c).

"(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving him an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to him as part of the application or on the basis of any other information before him-

"(A) that there is not in effect a regulation under subsection (i) (identified in such application) on the basis of which such application may be approved;

"(B) that such animal feed (including the proposed use of any new animal drug therein or thereon) does not conform to an applicable regulation published pursuant to subsection (i) referred to in the application, or that the purposes and conditions or indications of use prescribed, recommended, or suggested in the labeling of such feed do not conform to the applicable pur

poses 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

82 STAT. 349

82 STAT. 350

Recordkeeping.

Certification.

"(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.

66

"(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 officer 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

such fees,

"(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 iden-
tity, 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 subsec-
tion and are intended for use in manufacturing other drugs.
"(5) On petition of any interested person for the issuance, amend-
ment, 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

82 STAT. 351

59 Stat. 464;

76 Stat. 786.

21 USC 357.
Exemptions.

501(b) and 502(g) shall be determined by the application of the 52 Stat. 1049.
standards of strength, quality, and purity applicable under para- 21 USC 351,
graph (1) of this subsection, the tests and methods of assay applicable 352.
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."

DEFINITIONS

SEC. 102. Section 201 of the Federal Food, Drug, and Cosmetic Act,
as amended, is amended by-

(a) inserting "(except a new animal drug or an animal feed
bearing or containing a new animal drug)" after "Any drug" in
subparagraph (1) of paragraph (p);

52 Stat. 1041.

(b) inserting "(except a new animal drug or an animal feed 21 USC 321.
bearing or containing a new animal drug)" after "Any drug" in
subparagraph (2) of paragraph (p);

(c) striking out the period at the end of subparagraph (4) of
paragraph (s) and inserting in lieu thereof "; or", and by adding
a new subparagraph (5) to read as follows: "(5) a new animal
drug.";

(d) inserting "512," after "409" in paragraph (u); and
(e) adding at the end of such section the following new para-
graphs:

72 Stat. 1784;
74 Stat. 397.

21 USC 321.

79 Stat. 227.

"New animal

"(w) The term 'new animal drug' means any drug intended for use
for animals other than man, including any drug intended for use in drug."
animal feed but not including such animal feed,-

"(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific train-
ing and experience to evaluate the safety and effectiveness of
animal drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling thereof;

82 STAT. 352

Exception.

34 Stat. 7683 52 Stat. 1059. 21 USC 1-15

notes.

Ante, p. 350.

"Animal feed."

Ante, pp. 351, 343.

76 Stat. 784,

788.

21 USC 331.

52 Stat. 1042; 61 Stat. 11.

72 Stat. 1784; 74 Stat. 397. 21 USC 342.

59 Stat. 463.

21 USC 352.

21 USC 357.

except that such a drug not so recognized shall not be deemed to be a 'new animal drug' if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

"(2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions; or "(3) which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 512(n), is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug.

"(x) The term 'animal feed', as used in paragraph (w) of this section, in section 512, and in provisions of this Act referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal."

PROHIBITED ACTS AND PENALTIES

SEC. 103. Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by

(1) striking out "or" before "507," and inserting ", or 512 (j), (1), or (m)" after "507 (d) or (g)" in paragraph (e), and (2) adding "512," after "507," in paragraph (j).

ANIMAL DRUGS IN FEEDS AND RESIDUES THEREOF IN OTHER FOOD

SEC. 104. Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by

(1) striking out the word "or" before "(iii)" in clause (A) of subparagraph (2) of paragraph (a) and inserting “; or (iv) a new animal drug" after the words "color additive" therein; and

(2) adding before the semicolon following "commodity" at the end of the proviso to clause (C) of subparagraph (2) of paragraph (a) the following: "; or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 512”.

ANTIBIOTIC DRUGS FOR ANIMALS

SEC. 105. (a) Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by inserting "(except a drug for use in animals other than man)" after "represented as a drug" in paragraph (1).

(b) Section 507 of such Act is amended by inserting "(except drugs for use in animals other than man)" after "drugs" in the first sentence of subsection (a).