repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; and

(2) the term "name" shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. (b) On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments.

(c) Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs in any establishment which he owns or operates in any State shall immediately register with the Secretary his name, place of business, and such establishment.

(d) Every person duly registered in accordance with the foregoing subsections of this section shall immediately register with the Secretary any additional establishment which he owns or operates in any State and in which he begins the manufacture, preparation, propagation, compounding, or processing of a drug or drugs.

(e) The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j). Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code.

(f) The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this section; except that any list submitted pursuant to paragraph (3) of subsection (j) and the information accompanying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health.

(g) The foregoing subsections of this section shall not apply to

(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs, upon prescriptions of practitioners licensed to administer such drugs to patients under

the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail;

(2) practitioners licensed by law to prescribe or administer drugs and who manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice;

(3) persons who manufacture, prepare, propagate, compound, or process drugs solely for use in research, teaching, or chemical analysis and not for sale;

(4) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of persons in accordance with this section is not necessary for the protection of the public health. (h) Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 704 and shall be so inspected by one or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter.

(i) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (j) and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 801 (a) of this Act.

(j) (1) Every person who registers with the Secretary under subsection (b), (c), or (d) shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs (by established name (as defined in section 502 (e)) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs filed by him with the Secretary under this paragraph or paragraph (2) before such time of

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registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by

(A) in the case of a drug contained in such list and subject to section 505, 506, 507, or 512, a reference to the authority for the marketing of such drug and a copy of all labeling for such drug;

(B) in the case of any other drug contained in such list

(i) which is subject to section 503(b)(1), a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or

(ii) which is not subject to section 503(b) (1), the label and package insert for such drug and a representative sampling of any other labeling for such drug;

(C) in the case of any drug contained in such list which is described in subparagraph (B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular drug product the Secretary may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this Act; and

(D) if the registrant filing the list has determined that a particular drug product contained in such list is not subject to section 505, 506, 507, or 512, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular drug product.

(2) Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:

(A) A list of each drug introduced by the registrant for commercial distribution which has not been included in any list previously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug by its established name (as defined in section 502(e)) and by any proprietary name it may have and shall be accompanied by the other information required by paragraph (1).

(B) If since the date the registrant last made a report under this paragraph (or if he has not made. a report under this paragraph, since the effective date of this subsection) he has discontinued the

manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 502(e)) and by any proprietary name) of such drug.

(C) If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug (by established name (as defined in section 502(e)) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary pursuant to this subparagraph.

(D) Any material change in any information previously submitted pursuant to this paragraph or paragraph (1).

(3) The Secretary may also require each registrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this Act.

SEC. 511.1 **

NEW ANIMAL DRUGS

SEC. 512 [360].2(a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501 (a) (5) and section 402 (a) (2) (D) unless

(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section

1 Sec. 511 repealed by sec. 701 of P.L. 91-513.

Sec. 108 of P.L. 90-399, which added sec. 512, provides the following effective date and rules of application:

Sec. 108. (a) [Effective date Aug. 1, 1969.]

(b) (1) As used in this subsection, the term "effective date" means the effective date specified in subsection (a) of this section; the term "basic Act" means the Federal Food, Drug, and Cosmetic Act; and other terms used both in this section and the basic Act shall have the same meaning as they have, or had, at the time referred to in the context. under the basic Act.

(2) Any approval, prior to the effective date, of a new animal drug or of an animal feed bearing or containing a new animal drug, whether granted by approval of a new-drug application, master file, antibiotic regulation, or food additive regulation, shall continue in effect, and

with respect to such use or intended use of such drug,

(B) such drug, its labeling, and such use conform to such approved application, and

(C) in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to subsection (n) is in effect with respect to such drug.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee

(i) is the holder of an approved application under subsection (m) of this section; or

(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section. (2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 501 (a)(6) unless—

(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drug, as used in such animal feed,

(B) there is in effect an approval of an application pursuant to subsection (m) (1) of this section with respect to such animal feed, and

(C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (i) of this section

shall be subject to change in accordance with the provisions of the basic Act as amended by this Act.

(3) In the case of any drug (other than a drug subject to section 512(n) of the basic Act as amended by this Act) intended for use in animals other than man which, on October 9, 1962, (A) was commercially used or sold in the United States. (B) was not a new drug as defined by section 201 (p) of the basic Act as then in force, and (C) was not covered by an effective application under section 505 of that Act, the words "effectiveness" and "effective" contained in section 201 (w) as added by this Act to the basic Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day. (4) Regulations providing for fees (and advance deposits to cover fees) which on the day preceding the effective date applicable under subsection (a) of this section were in effect pursuant to section 507 of the basic Act shall, except as the Secretary may otherwise prescribe, be deemed to apply also under section 512(n) of the basic Act, and appropriations of fees (and of advance deposits to cover fees) available for the purposes specified in such section 507 as in effect prior to the effective date shall also be available for the purposes specified in section 512(n), including preparatory work or proceed. ings prior to that date.