21 U.S.C. § 354 — Veterinary feed directive drugs

Page 185 TITLE 21—FOOD AND DRUGS § 354 proved application under section 355(j) of this title to maintain its labeling in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations). (j) Reports Not later than 4 years after December 27, 2020, and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that— (1) describes the actions of the Secretary under this section, including— (A) the number of covered drugs and de- scription of the types of drugs the Secretary has selected for labeling changes and the ra- tionale for such recommended changes; and (B) the number of times the Secretary en- tered into discussions concerning a disagree- ment with an application holder or holders and a summary of the decision regarding a labeling change, if any; and (2) includes any recommendations of the Secretary for modifying the program under this section. (June 25, 1938, ch. 675, § 503D, as added Pub. L. 116–260, div. BB, title III, § 324, Dec. 27, 2020, 134 Stat. 2933.) § 354. Veterinary feed directive drugs (a) Lawful veterinary feed directive requirement (1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of this title, a conditionally-approved application filed pursu- ant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title to use under the professional supervision of a li- censed veterinarian is a veterinary feed direc- tive drug. Any animal feed bearing or con- taining a veterinary feed directive drug shall be fed to animals only by or upon a lawful veteri- nary feed directive issued by a licensed veteri- narian in the course of the veterinarian’s profes- sional practice. When labeled, distributed, held, and used in accordance with this section, a vet- erinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from section 352(f) of this title. (2) A veterinary feed directive is lawful if it— (A) contains such information as the Sec- retary may by general regulation or by order require; and (B) is in compliance with the conditions and indications for use of the drug set forth in the notice published pursuant to section 360b(i) of this title, or the index listing pursuant to sec- tion 360ccc–1(e) of this title. (3)(A) Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed direc- tive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to an- other person for further distribution. Such per- son distributing the feed shall maintain a writ- ten acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal produc- tion facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier. (B) Every person required under subparagraph (A) to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Sec- retary, permit such officer or employee at all reasonable times to have access to and copy and verify such records. (C) Any person who distributes animal feed bearing or containing a veterinary feed directive drug shall upon first engaging in such distribu- tion notify the Secretary of that person’s name and place of business. The failure to provide such notification shall be deemed to be an act which results in the drug being misbranded. (b) Labeling and advertising A veterinary feed directive drug and any feed bearing or containing a veterinary feed directive drug shall be deemed to be misbranded if their labeling fails to bear such cautionary statement and such other information as the Secretary may by general regulation or by order prescribe, or their advertising fails to conform to the con- ditions and indications for use published pursu- ant to section 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title or fails to contain the general cautionary statement prescribed by the Secretary. (c) Nonprescription status Neither a drug subject to this section, nor ani- mal feed bearing or containing such a drug, shall be deemed to be a prescription article under any Federal or State law. (June 25, 1938, ch. 675, § 504, as added Pub. L. 104–250, § 5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108–282, title I, § 102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.) Editorial Notes PRIOR PROVISIONS A prior section 354, act June 25, 1938, ch. 675, § 504, 52 Stat. 1052, which directed Secretary to promulgate reg- ulations for listing of coal-tar colors, was repealed ef- fective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, by Pub. L. 86–618, title I, § 103(a)(2), title II, § 202, July 12, 1960, 74 Stat. 398, 404. AMENDMENTS 2004—Subsec. (a)(1). Pub. L. 108–282, § 102(b)(5)(G), sub- stituted ‘‘360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title’’ for ‘‘360b(b) of this title’’. Subsecs. (a)(2)(B), (b). Pub. L. 108–282, § 102(b)(5)(H), substituted ‘‘360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title’’ for ‘‘360b(i) of this title’’. Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an application is filed under this sub- section for a drug, and a patent of the type de- scribed in subparagraph (A)(viii) is issued after the filing date but before approval of the appli- cation, the applicant shall amend the applica- tion to include the patent number and expira- tion date. (2) An application submitted under paragraph (1) for a drug for which the investigations de- scribed in clause (A) of such paragraph and re- lied upon by the applicant for approval of the application were not conducted by or for the ap- plicant and for which the applicant has not ob- tained a right of reference or use from the per- son by or for whom the investigations were con- ducted shall also include— (A) a certification, in the opinion of the ap- plicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for which information is re- quired to be filed under paragraph (1) or sub- section (c)— (i) that such patent information has not been filed, (ii) that such patent has expired, (iii) of the date on which such patent will expire, or (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and (B) if with respect to the drug for which in- vestigations described in paragraph (1)(A) were conducted information was filed under para- graph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. (3) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE INFRINGED.— (A) AGREEMENT TO GIVE NOTICE.—An appli- cant that makes a certification described in paragraph (2)(A)(iv) shall include in the appli- cation a statement that the applicant will give notice as required by this paragraph. (B) TIMING OF NOTICE.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall give notice as required under this paragraph— (i) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Sec- retary informs the applicant that the appli- cation has been filed; or (ii) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given no- tice with respect to another such certifi- cation contained in the application or in an amendment or supplement to the applica- tion. (C) RECIPIENTS OF NOTICE.—An applicant re- quired under this paragraph to give notice shall give notice to— (i) each owner of the patent that is the subject of the certification (or a representa- tive of the owner designated to receive such a notice); and (ii) the holder of the approved application under this subsection for the drug that is claimed by the patent or a use of which is claimed by the patent (or a representative of the holder designated to receive such a no- tice). (D) CONTENTS OF NOTICE.—A notice required under this paragraph shall— (i) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this sub- section for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and (ii) include a detailed statement of the fac- tual and legal basis of the opinion of the ap-