21 USC 360b(j): Federal Food, Drug, and Cosmetic Act

Page 297

TITLE 21—FOOD AND DRUGS

Statutory Notes and Related Subsidiaries
CONSTRUCTION
Nothing in this section to be construed to restrict the
prescribing of antimicrobial drugs or other products,
including drugs approved under section 356(h) of this
title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255,
set out as a Construction of 2016 Amendments note
under section 356 of this title.
REQUESTS FOR UPDATES TO INTERPRETIVE CRITERIA
WEBSITE
Pub. L. 114–255, div. A, title III, § 3044(d), Dec. 13, 2016,
130 Stat. 1121, provided that: ‘‘Chapter 35 of title 44,
United States Code, shall not apply to the collection of
information from interested parties regarding updating
the lists established under section 511A(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360a–2(b)]
and posted on the Interpretive Criteria Website established under section 511A(c) [probably means section
511A(b)] of such Act.’’

§ 360b. New animal drugs
(a) Unsafe new animal drugs and animal feed
containing such drugs; conditions of safety;
exemption of drugs for research; import tolerances
(1) A new animal drug shall, with respect to
any particular use or intended use of such drug,
be deemed unsafe for purposes of section
351(a)(5) of this title and section 342(a)(2)(C)(ii)
of this title unless—
(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug,
and such drug, its labeling, and such use conform to such approved application;
(B) there is in effect a conditional approval
of an application filed pursuant to section
360ccc of this title with respect to such use or
intended use of such drug, and such drug, its
labeling, and such use conform to such conditionally approved application;
(C) there is in effect an index listing pursuant to section 360ccc–1 of this title with respect to such use or intended use of such drug
in a minor species, and such drug, its labeling,
and such use conform to such index listing; or
(D) there is in effect an authorization pursuant to section 360bbb–3 of this title with respect to such use or intended use of such drug,
and such drug, its labeling, and such use conform to any conditions of such authorization.
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) holds a license issued
under subsection (m) and has in its possession
current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a
user of the drug, ship such drug only to a holder
of a license issued under subsection (m).
(2) An animal feed bearing or containing a new
animal drug shall, with respect to any par-

§ 360b

ticular use or intended use of such animal feed
be deemed unsafe for purposes of section
351(a)(6) of this title unless—
(A) there is in effect—
(i) an approval of an application filed pursuant to subsection (b) with respect to such
drug, as used in such animal feed, and such
animal feed and its labeling, distribution,
holding, and use conform to such approved
application;
(ii) a conditional approval of an application filed pursuant to section 360ccc of this
title with respect to such drug, as used in
such animal feed, and such animal feed and
its labeling, distribution, holding, and use
conform to such conditionally approved application; or
(iii) an index listing pursuant to section
360ccc–1 of this title with respect to such
drug, as used in such animal feed, and such
animal feed and its labeling, distribution,
holding, and use conform to such index listing; and
(B) such animal feed is manufactured at a
site for which there is in effect a license issued
pursuant to subsection (m)(1) to manufacture
such animal feed.
(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be
deemed unsafe for the purposes of section
351(a)(5) or (6) of this title if such article is for
investigational use and conforms to the terms of
an exemption in effect with respect thereto
under subsection (j).
(4)(A) Except as provided in subparagraph (B),
if an approval of an application filed under subsection (b) is in effect with respect to a particular use or intended use of a new animal
drug, the drug shall not be deemed unsafe for
the purposes of paragraph (1) and shall be exempt from the requirements of section 352(f) of
this title with respect to a different use or intended use of the drug, other than a use in or on
animal feed, if such use or intended use—
(i) is by or on the lawful written or oral
order of a licensed veterinarian within the
context of a veterinarian-client-patient relationship, as defined by the Secretary; and
(ii) is in compliance with regulations promulgated by the Secretary that establish the
conditions for such different use or intended
use.
The regulations promulgated by the Secretary
under clause (ii) may prohibit particular uses of
an animal drug and shall not permit such different use of an animal drug if the labeling of
another animal drug that contains the same active ingredient and which is in the same dosage
form and concentration provides for such different use.
(B) If the Secretary finds that there is a reasonable probability that a use of an animal drug
authorized under subparagraph (A) may present
a risk to the public health, the Secretary may—
(i) establish a safe level for a residue of an
animal drug when it is used for such different
use authorized by subparagraph (A); and
(ii) require the development of a practical,
analytical method for the detection of residues of such drug above the safe level established under clause (i).

§ 360b

TITLE 21—FOOD AND DRUGS

The use of an animal drug that results in residues exceeding a safe level established under
clause (i) shall be considered an unsafe use of
such drug under paragraph (1). Safe levels may
be established under clause (i) either by regulation or order.
(C) The Secretary may by general regulation
provide access to the records of veterinarians to
ascertain any use or intended use authorized
under subparagraph (A) that the Secretary has
determined may present a risk to the public
health.
(D) If the Secretary finds, after affording an
opportunity for public comment, that a use of
an animal drug authorized under subparagraph
(A) presents a risk to the public health or that
an analytical method required under subparagraph (B) has not been developed and submitted
to the Secretary, the Secretary may, by order,
prohibit any such use.
(5) If the approval of an application filed under
section 355 of this title is in effect, the drug
under such application shall not be deemed unsafe for purposes of paragraph (1) and shall be
exempt from the requirements of section 352(f)
of this title with respect to a use or intended use
of the drug in animals if such use or intended
use—
(A) is by or on the lawful written or oral
order of a licensed veterinarian within the
context of a veterinarian-client-patient relationship, as defined by the Secretary; and
(B) is in compliance with regulations promulgated by the Secretary that establish the
conditions for the use or intended use of the
drug in animals.
(6) For purposes of section 342(a)(2)(D) 1 of this
title, a use or intended use of a new animal drug
shall not be deemed unsafe under this section if
the Secretary establishes a tolerance for such
drug and any edible portion of any animal imported into the United States does not contain
residues exceeding such tolerance. In establishing such tolerance, the Secretary shall rely
on data sufficient to demonstrate that a proposed tolerance is safe based on similar food
safety criteria used by the Secretary to establish tolerances for applications for new animal
drugs filed under subsection (b)(1). The Secretary may consider and rely on data submitted
by the drug manufacturer, including data submitted to appropriate regulatory authorities in
any country where the new animal drug is lawfully used or data available from a relevant
international organization, to the extent such
data are not inconsistent with the criteria used
by the Secretary to establish a tolerance for applications for new animal drugs filed under subsection (b)(1). For purposes of this paragraph,
‘‘relevant international organization’’ means
the Codex Alimenterius 2 Commission or other
international organization deemed appropriate
by the Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance established under this paragraph if information demonstrates that the use of the new
animal drug under actual use conditions results
in food being imported into the United States
1 See
2 So

References in Text note below.
in original. Probably should be ‘‘Alimentarius’’.

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with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.
(b) Filing application for uses of new animal
drug; contents; patent information; abbreviated application; presubmission conference
(1) Any person may file with the Secretary an
application with respect to any intended use or
uses of a new animal drug. Such person shall
submit to the Secretary as a part of the application (A) full reports of investigations which
have been made to show whether or not such
drug is safe and effective for use; (B) a full list
of the articles used as components of such drug;
(C) a full statement of the composition of such
drug; (D) a full description of the methods used
in, and the facilities and controls used for, the
manufacture, processing, and packing of such
drug; (E) such samples of such drug and of the
articles used as components thereof, of any animal feed for use in or on which such drug is intended, and of the edible portions or products
(before or after slaughter) of animals to which
such drug (directly or in or on animal feed) is intended to be administered, as the Secretary may
require; (F) specimens of the labeling proposed
to be used for such drug, or in case such drug is
intended for use in animal feed, proposed labeling appropriate for such use, and specimens of
the labeling for the drug to be manufactured,
packed, or distributed by the applicant; (G) a description of practicable methods for determining
the quantity, if any, of such drug in or on food,
and any substance formed in or on food, because
of its use; and (H) the proposed tolerance or
withdrawal period or other use restrictions for
such drug if any tolerance or withdrawal period
or other use restrictions are required in order to
assure that the proposed use of such drug will be
safe. The applicant shall file with the application the patent number and the expiration date
of any patent which claims the new animal drug
for which the applicant filed the application or
which claims a method of using such drug and
with respect to which a claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and
a patent which claims such drug or a method of
using such drug is issued after the filing date
but before approval of the application, the applicant shall amend the application to include the
information required by the preceding sentence.
Upon approval of the application, the Secretary
shall publish information submitted under the
two preceding sentences.
(2) Any person may file with the Secretary an
abbreviated application for the approval of a
new animal drug. An abbreviated application
shall contain the information required by subsection (n).
(3) Any person intending to file an application
under paragraph (1), section 360ccc of this title,
or a request for an investigational exemption
under subsection (j) shall be entitled to one or
more conferences prior to such submission to
reach an agreement acceptable to the Secretary
establishing a submission or an investigational
requirement, which may include a requirement

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for a field investigation. A decision establishing
a submission or an investigational requirement
shall bind the Secretary and the applicant or requestor unless (A) the Secretary and the applicant or requestor mutually agree to modify the
requirement, or (B) the Secretary by written
order determines that a substantiated scientific
requirement essential to the determination of
safety or effectiveness of the animal drug involved has appeared after the conference. No
later than 25 calendar days after each such conference, the Secretary shall provide a written
order setting forth a scientific justification specific to the animal drug and intended uses under
consideration if the agreement referred to in the
first sentence requires more than one field investigation as being essential to provide substantial evidence of effectiveness for the intended uses of the drug. Nothing in this paragraph shall be construed as compelling the Secretary to require a field investigation.
(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection
shall be submitted by electronic means in such
format as the Secretary may require.
(c) Period for submission and approval of application; period for notice and expedition of
hearing; period for issuance of order; abbreviated applications; withdrawal periods; effective date of approval; relationship to
other applications; withdrawal or suspension
of approval; bioequivalence; filing of additional patent information
(1) Within one hundred and eighty days after
the filing of an application pursuant to subsection (b), 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 subsection (d) applies, or (B) give the applicant notice of an opportunity for a hearing
before the Secretary under subsection (d) on the
question whether such application is approvable.
If the applicant elects to accept the opportunity
for a hearing by written request within thirty
days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary
and the applicant otherwise agree. Any such
hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon
shall be issued within ninety days after the date
fixed by the Secretary for filing final briefs.
(2)(A) Subject to subparagraph (C), the Secretary shall approve an abbreviated application
for a drug unless the Secretary finds—
(i) the methods used in, or the facilities and
controls used for, the manufacture, processing, and packing of the drug are inadequate
to assure and preserve its identity, strength,
quality, and purity;
(ii) the conditions of use prescribed, recommended, or suggested in the proposed labeling are not reasonably certain to be followed
in practice or, except as provided in subparagraph (B), information submitted with the application is insufficient to show that each of
the proposed conditions of use or similar limitations (whether in the labeling or published

§ 360b

pursuant to subsection (i)) have been previously approved for the approved new animal
drug referred to in the application;
(iii) information submitted with the application is insufficient to show that the active ingredients are the same as those of the approved new animal drug referred to in the application;
(iv)(I) if the application is for a drug whose
active ingredients, route of administration,
dosage form, strength, or use with other animal drugs in animal feed is the same as the active ingredients, route of administration, dosage form, strength, or use with other animal
drugs in animal feed of the approved new animal drug referred to in the application, information submitted in the application is insufficient to show that the active ingredients,
route
of
administration,
dosage
form,
strength, or use with other animal drugs in
animal feed is the same as that of the approved new animal drug, or
(II) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal
drugs in animal feed is different from that of
the approved new animal drug referred to in
the application, no petition to file an application for the drug with the different active ingredients, route of administration, dosage
form, strength, or use with other animal drugs
in animal feed was approved under subsection
(n)(3);
(v) if the application was filed pursuant to
the approval of a petition under subsection
(n)(3), the application did not contain the information required by the Secretary respecting the active ingredients, route of administration, dosage form, strength, or use with
other animal drugs in animal feed which is not
the same;
(vi) information submitted in the application is insufficient to show that the drug is
bioequivalent to the approved new animal
drug referred to in the application, or if the
application is filed under a petition approved
pursuant to subsection (n)(3), information submitted in the application is insufficient to
show that the active ingredients of the new
animal drug are of the same pharmacological
or therapeutic class as the pharmacological or
therapeutic class of the approved new animal
drug and that the new animal drug can be expected to have the same therapeutic effect as
the approved new animal drug when used in
accordance with the labeling;
(vii) information submitted in the application is insufficient to show that the labeling
proposed for the drug is the same as the labeling approved for the approved new animal
drug referred to in the application except for
changes required because of differences approved under a petition filed under subsection
(n)(3), because of a different withdrawal period, or because the drug and the approved new
animal drug are produced or distributed by
different manufacturers;
(viii) information submitted in the application or any other information available to the
Secretary shows that (I) the inactive ingredients of the drug are unsafe for use under the

§ 360b

TITLE 21—FOOD AND DRUGS

conditions prescribed, recommended, or suggested in the labeling proposed for the drug,
(II) the composition of the drug is unsafe
under such conditions because of the type or
quantity of inactive ingredients included or
the manner in which the inactive ingredients
are included, or (III) in the case of a drug for
food producing animals, the inactive ingredients of the drug or its composition may be unsafe with respect to human food safety;
(ix) the approval under subsection (b)(1) of
the approved new animal drug referred to in
the application filed under subsection (b)(2)
has been withdrawn or suspended for grounds
described in paragraph (1) of subsection (e),
the Secretary has published a notice of a hearing to withdraw approval of the approved new
animal drug for such grounds, the approval
under this paragraph of the new animal drug
for which the application under subsection
(b)(2) was filed has been withdrawn or suspended under subparagraph (G) for such
grounds, or the Secretary has determined that
the approved new animal drug has been withdrawn from sale for safety or effectiveness reasons;
(x) the application does not meet any other
requirement of subsection (n); or
(xi) the application contains an untrue
statement of material fact.
(B) If the Secretary finds that a new animal
drug for which an application is submitted
under subsection (b)(2) is bioequivalent to the
approved new animal drug referred to in such
application and that residues of the new animal
drug are consistent with the tolerances established for such approved new animal drug but at
a withdrawal period which is different than the
withdrawal period approved for such approved
new animal drug, the Secretary may establish,
on the basis of information submitted, such different withdrawal period as the withdrawal period for the new animal drug for purposes of the
approval of such application for such drug.
(C) Within 180 days of the initial receipt of an
application under subsection (b)(2) or within
such additional period as may be agreed upon by
the Secretary and the applicant, the Secretary
shall approve or disapprove the application.
(D) The approval of an application filed under
subsection (b)(2) shall be made effective on the
last applicable date determined under the following:
(i) If the applicant only made a certification
described in clause (i) or (ii) of subsection
(n)(1)(G) or in both such clauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described in clause (iii) of subsection (n)(1)(G),
the approval may be made effective on the
date certified under clause (iii).
(iii) If the applicant made a certification described in clause (iv) of subsection (n)(1)(G),
the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of
the certification before the expiration of 45
days from the date the notice provided under
subsection (n)(2)(B)(i) is received. If such an
action is brought before the expiration of such
days, the approval shall be made effective

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upon the expiration of the 30 month period beginning on the date of the receipt of the notice
provided under subsection (n)(2)(B) or such
shorter or longer period as the court may
order because either party to the action failed
to reasonably cooperate in expediting the action, except that if before the expiration of
such period—
(I) the court decides that such patent is invalid or not infringed, the approval shall be
made effective on the date of the court decision,
(II) the court decides that such patent has
been infringed, the approval shall be made
effective on such date as the court orders
under section 271(e)(4)(A) of title 35, or
(III) the court grants a preliminary injunction prohibiting the applicant from engaging
in the commercial manufacture or sale of
the drug until the court decides the issues of
patent validity and infringement and if the
court decides that such patent is invalid or
not infringed, the approval shall be made effective on the date of such court decision.
In such an action, each of the parties shall
reasonably cooperate in expediting the action.
Until the expiration of 45 days from the date
the notice made under subsection (n)(2)(B) is
received, no action may be brought under section 2201 of title 28 for a declaratory judgment
with respect to the patent. Any action brought
under section 2201 of title 28 shall be brought
in the judicial district where the defendant
has its principal place of business or a regular
and established place of business.
(iv) If the application contains a certification described in clause (iv) of subsection
(n)(1)(G) and is for a drug for which a previous
application has been filed under this subsection containing such a certification, the application shall be made effective not earlier
than 180 days after—
(I) the date the Secretary receives notice
from the applicant under the previous application of the first commercial marketing of
the drug under the previous application, or
(II) the date of a decision of a court in an
action described in subclause (III) 3 holding
the patent which is the subject of the certification to be invalid or not infringed,
whichever is earlier.
(E) If the Secretary decides to disapprove an
application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant
elects to accept the opportunity for hearing by
written request within 30 days after such notice,
such hearing shall commence not more than 90
days after the expiration of such 30 days unless
the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted
on an expedited basis and the Secretary’s order
thereon shall be issued within 90 days after the
date fixed by the Secretary for filing final briefs.
(F)(i) If an application submitted under subsection (b)(1) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21,
3 So

in original. Probably should be ‘‘clause (iii)(III)’’.

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Code of Federal Regulations (or any successor
regulations)) of which has been approved in any
other application under subsection (b)(1), is approved after November 16, 1988, no application
may be submitted under subsection (b)(2) which
refers to the drug for which the subsection (b)(1)
application was submitted before the expiration
of 5 years from the date of the approval of the
application under subsection (b)(1), except that
such an application may be submitted under
subsection (b)(2) after the expiration of 4 years
from the date of the approval of the subsection
(b)(1) application if it contains a certification of
patent invalidity or noninfringement described
in clause (iv) of subsection (n)(1)(G). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is
commenced during the one-year period beginning 48 months after the date of the approval of
the subsection (b) application, the 30 month period referred to in subparagraph (D)(iii) shall be
extended by such amount of time (if any) which
is required for seven and one-half years to have
elapsed from the date of approval of the subsection (b) application.
(ii) If an application submitted under subsection (b)(1) for a drug, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations
(or any successor regulations)) that has been approved in another application approved under
such subsection, is approved after November 16,
1988, and if such application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the
case of food producing animals, human food
safety studies (other than bioequivalence studies or residue depletion studies, except residue
depletion studies for minor uses or minor species) required for the approval of the application
and conducted or sponsored by the applicant,
the Secretary may not make the approval of an
application submitted under subsection (b)(2) for
the conditions of approval of such drug in the
subsection (b)(1) application effective before the
expiration of 3 years from the date of the approval of the application under subsection (b)(1)
for such drug.
(iii) If a supplement to an application approved under subsection (b)(1) is approved after
November 16, 1988, and the supplement contains
substantial evidence of the effectiveness of the
drug involved, any studies of animal safety, or,
in the case of food producing animals, human
food safety studies (other than bioequivalence
studies or residue depletion studies, except residue depletion studies for minor uses or minor
species) required for the approval of the supplement and conducted or sponsored by the person
submitting the supplement, the Secretary may
not make the approval of an application submitted under subsection (b)(2) for a change approved in the supplement effective before the expiration of 3 years from the date of the approval
of the supplement.
(iv) An applicant under subsection (b)(1) who
comes within the provisions of clause (i) of this
subparagraph as a result of an application which
seeks approval for a use solely in non-food producing animals, may elect, within 10 days of re-

§ 360b

ceiving such approval, to waive clause (i) of this
subparagraph, in which event the limitation on
approval of applications submitted under subsection (b)(2) set forth in clause (ii) of this subparagraph shall be applicable to the subsection
(b)(1) application.
(v) If an application (including any supplement to a new animal drug application) submitted under subsection (b)(1) for a new animal
drug for a food-producing animal use, which includes an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations))
which has been the subject of a waiver under
clause (iv) is approved after November 16, 1988,
and if the application contains substantial evidence of the effectiveness of the drug involved,
any studies of animal safety, or human food
safety studies (other than bioequivalence studies or residue depletion studies, except residue
depletion studies for minor uses or minor species) required for the new approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval
of an application (including any supplement to
such application) submitted under subsection
(b)(2) for the new conditions of approval of such
drug in the subsection (b)(1) application effective before the expiration of five years from the
date of approval of the application under subsection (b)(1) for such drug. The provisions of
this paragraph shall apply only to the first approval for a food-producing animal use for the
same applicant after the waiver under clause
(iv).
(G) If an approved application submitted under
subsection (b)(2) for a new animal drug refers to
a drug the approval of which was withdrawn or
suspended for grounds described in paragraph (1)
or (2) of subsection (e) or was withdrawn or suspended under this subparagraph or which, as determined by the Secretary, has been withdrawn
from sale for safety or effectiveness reasons, the
approval of the drug under this paragraph shall
be withdrawn or suspended—
(i) for the same period as the withdrawal or
suspension under subsection (e) or this subparagraph, or
(ii) if the approved new animal drug has been
withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that
the withdrawal from sale is not for safety or
effectiveness reasons.
(H) For purposes of this paragraph:
(i) The term ‘‘bioequivalence’’ means the
rate and extent to which the active ingredient
or therapeutic ingredient is absorbed from a
new animal drug and becomes available at the
site of drug action.
(ii) A new animal drug shall be considered to
be bioequivalent to the approved new animal
drug referred to in its application under subsection (n) if—
(I) the rate and extent of absorption of the
drug do not show a significant difference
from the rate and extent of absorption of the
approved new animal drug referred to in the
application when administered at the same
dose of the active ingredient under similar
experimental conditions in either a single
dose or multiple doses;

§ 360b

TITLE 21—FOOD AND DRUGS

(II) the extent of absorption of the drug
does not show a significant difference from
the extent of absorption of the approved new
animal drug referred to in the application
when administered at the same dose of the
active ingredient under similar experimental
conditions in either a single dose or multiple
doses and the difference from the approved
new animal drug in the rate of absorption of
the drug is intentional, is reflected in its
proposed labeling, is not essential to the attainment of effective drug concentrations in
use, and is considered scientifically insignificant for the drug in attaining the intended purposes of its use and preserving
human food safety; or
(III) in any case in which the Secretary determines that the measurement of the rate
and extent of absorption or excretion of the
new animal drug in biological fluids is inappropriate or impractical, an appropriate
acute pharmacological effects test or other
test of the new animal drug and, when
deemed scientifically necessary, of the approved new animal drug referred to in the
application in the species to be tested or in
an appropriate animal model does not show
a significant difference between the new animal drug and such approved new animal
drug when administered at the same dose
under similar experimental conditions.
If the approved new animal drug referred to in
the application for a new animal drug under
subsection (n) is approved for use in more than
one animal species, the bioequivalency information described in subclauses (I), (II), and
(III) shall be obtained for one species, or if the
Secretary deems appropriate based on scientific principles, shall be obtained for more
than one species. The Secretary may prescribe
the dose to be used in determining bioequivalency under subclause (I), (II), or (III). To assure that the residues of the new animal drug
will be consistent with the established tolerances for the approved new animal drug referred to in the application under subsection
(b)(2) upon the expiration of the withdrawal
period contained in the application for the
new animal drug, the Secretary shall require
bioequivalency data or residue depletion studies of the new animal drug or such other data
or studies as the Secretary considers appropriate based on scientific principles. If the
Secretary requires one or more residue studies
under the preceding sentence, the Secretary
may not require that the assay methodology
used to determine the withdrawal period of
the new animal drug be more rigorous than
the methodology used to determine the withdrawal period for the approved new animal
drug referred to in the application. If such
studies are required and if the approved new
animal drug, referred to in the application for
the new animal drug for which such studies
are required, is approved for use in more than
one animal species, such studies shall be conducted for one species, or if the Secretary
deems appropriate based on scientific principles, shall be conducted for more than one
species.

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(3) If the patent information described in subsection (b)(1) could not be filed with the submission of an application under subsection (b)(1) because the application was filed before the patent
information was required under subsection (b)(1)
or a patent was issued after the application was
approved under such subsection, the holder of an
approved application shall file with the Secretary the patent number and the expiration
date of any patent which claims the new animal
drug for which the application was filed or
which claims a method of using such drug and
with respect to which a claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of
an approved application could not file patent information under subsection (b)(1) because it was
not required at the time the application was approved, the holder shall file such information
under this subsection not later than 30 days
after November 16, 1988, and if the holder of an
approved application could not file patent information under subsection (b)(1) because no patent had been issued when an application was
filed or approved, the holder shall file such information under this subsection not later than
30 days after the date the patent involved is
issued. Upon the submission of patent information under this subsection, the Secretary shall
publish it.
(4) A drug manufactured in a pilot or other
small facility may be used to demonstrate the
safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a determination that a full scale
production facility is necessary to ensure the
safety or effectiveness of the drug.
(d) Grounds for refusing application; approval of
application; factors; ‘‘substantial evidence’’
defined; combination drugs
(1) If the Secretary finds, after due notice to
the applicant in accordance with subsection (c)
and giving him an opportunity for a hearing, in
accordance with said subsection, that—
(A) the investigations, reports of which are
required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe
for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;
(B) the results of such tests show that such
drug is unsafe for use under such conditions or
do not show that such drug is safe for use
under such conditions;
(C) the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity;
(D) upon the basis of the information submitted to him as part of the application, or
upon the basis of any other information before
him with respect to such drug, he has insufficient information to determine whether such
drug is safe for use under such conditions;
(E) evaluated on the basis of the information
submitted to him as part of the application

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TITLE 21—FOOD AND DRUGS

and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect
it purports or is represented to have under the
conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof;
(F) upon the basis of information submitted
to the Secretary as part of the application or
any other information before the Secretary
with respect to such drug, any use prescribed,
recommended, or suggested in labeling proposed for such drug will result in a residue of
such drug in excess of a tolerance found by the
Secretary to be safe for such drug;
(G) the application failed to contain the patent information prescribed by subsection
(b)(1);
(H) based on a fair evaluation of all material
facts, such labeling is false or misleading in
any particular; or
(I) such drug induces cancer when ingested
by man or animal or, after tests which are appropriate for the evaluation of the safety of
such drug, induces cancer in man or animal,
except that the foregoing provisions of this
subparagraph shall not apply with respect to
such drug if the Secretary finds that, under
the conditions of use specified in proposed labeling and reasonably certain to be followed in
practice (i) such drug will not adversely affect
the animals for which it is intended, and (ii)
no residue of such drug will be found (by methods of examination prescribed or approved by
the Secretary by regulations, which regulations shall not be subject to subsections (c),
(d), and (h)), in any edible portion of such animals after slaughter or in any food yielded by
or derived from the living animals;
he shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearings, the Secretary finds that
subparagraphs (A) through (I) do not apply, he
shall issue an order approving the application.
(2) In determining whether such drug is safe
for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among
other relevant factors, (A) the probable consumption of such drug and of any substance
formed in or on food because of the use of such
drug, (B) the cumulative effect on man or animal of such drug, taking into account any
chemically or pharmacologically related substance, (C) safety factors which in the opinion of
experts, qualified by scientific training and experience to evaluate the safety of such drugs,
are appropriate for the use of animal experimentation data, and (D) whether the conditions of
use prescribed, recommended, or suggested in
the proposed labeling are reasonably certain to
be followed in practice. Any order issued under
this subsection refusing to approve an application shall state the findings upon which it is
based.
(3) As used in this section, the term ‘‘substantial evidence’’ means evidence consisting of one
or more adequate and well controlled investigations, such as—
(A) a study in a target species;
(B) a study in laboratory animals;
(C) any field investigation that may be required under this section and that meets the

§ 360b

requirements of subsection (b)(3) if a presubmission conference is requested by the applicant;
(D) a bioequivalence study; or
(E) an in vitro study;
by experts qualified by scientific training and
experience to evaluate the effectiveness of the
drug involved, on the basis of which it could
fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling
thereof.
(4) In a case in which an animal drug contains
more than one active ingredient, or the labeling
of the drug prescribes, recommends, or suggests
use of the drug in combination with one or more
other animal drugs, and the active ingredients
or drugs intended for use in the combination
have previously been separately approved pursuant to an application submitted under subsection (b)(1) for particular uses and conditions
of use for which they are intended for use in the
combination—
(A) the Secretary shall not issue an order
under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on human food safety grounds unless
the Secretary finds that the application fails
to establish that—
(i) none of the active ingredients or drugs
intended for use in the combination, respectively, at the longest withdrawal time of any
of the active ingredients or drugs in the
combination, respectively, exceeds its established tolerance; or
(ii) none of the active ingredients or drugs
in the combination interferes with the methods of analysis for another of the active ingredients or drugs in the combination, respectively;
(B) the Secretary shall not issue an order
under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on target animal safety grounds unless the Secretary finds that—
(i)(I) there is a substantiated scientific
issue, specific to one or more of the active
ingredients or animal drugs in the combination, that cannot adequately be evaluated
based on information contained in the application for the combination (including any
investigations, studies, or tests for which
the applicant has a right of reference or use
from the person by or for whom the investigations, studies, or tests were conducted);
or
(II) there is a scientific issue raised by target animal observations contained in studies
submitted to the Secretary as part of the application; and
(ii) based on the Secretary’s evaluation of
the information contained in the application
with respect to the issues identified in
clauses (i)(I) and (II), paragraph (1)(A), (B),
or (D) apply;
(C) except in the case of a combination that
contains a nontopical antibacterial ingredient
or animal drug, the Secretary shall not issue

§ 360b

TITLE 21—FOOD AND DRUGS

an order under paragraph (1)(E) refusing to approve an application for a combination animal
drug intended for use other than in animal
feed or drinking water unless the Secretary
finds that the application fails to demonstrate
that—
(i) there is substantial evidence that any
active ingredient or animal drug intended
only for the same use as another active ingredient or animal drug in the combination
makes a contribution to labeled effectiveness;
(ii) each active ingredient or animal drug
intended for at least one use that is different
from all other active ingredients or animal
drugs used in the combination provides appropriate concurrent use for the intended
target population; or
(iii) where based on scientific information
the Secretary has reason to believe the active ingredients or animal drugs may be
physically incompatible or have disparate
dosing regimens, such active ingredients or
animal drugs are physically compatible or
do not have disparate dosing regimens; and
(D) the Secretary shall not issue an order
under paragraph (1)(E) refusing to approve an
application for a combination animal drug intended for use in animal feed or drinking
water unless the Secretary finds that the application fails to demonstrate that—
(i) there is substantial evidence that any
active ingredient or animal drug intended
only for the same use as another active ingredient or animal drug in the combination
makes a contribution to the labeled effectiveness;
(ii) each of the active ingredients or animal drugs intended for at least one use that
is different from all other active ingredients
or animal drugs used in the combination
provides appropriate concurrent use for the
intended target population;
(iii) where a combination contains more
than one nontopical antibacterial ingredient
or animal drug, there is substantial evidence
that each of the nontopical antibacterial ingredients or animal drugs makes a contribution to the labeled effectiveness, except that
for purposes of this clause, antibacterial ingredient or animal drug does not include the
ionophore or arsenical classes of animal
drugs; or
(iv) where based on scientific information
the Secretary has reason to believe the active ingredients or animal drugs intended for
use in drinking water may be physically incompatible, such active ingredients or animal drugs intended for use in drinking water
are physically compatible.
(5) In reviewing an application that proposes a
change to add an intended use for a minor use or
a minor species to an approved new animal drug
application, the Secretary shall reevaluate only
the relevant information in the approved application to determine whether the application for
the minor use or minor species can be approved.
A decision to approve the application for the
minor use or minor species is not, implicitly or
explicitly, a reaffirmation of the approval of the
original application.

Page 304

(e) Withdrawal of approval; grounds; immediate
suspension upon finding imminent hazard to
health of man or animals
(1) The Secretary shall, after due notice and
opportunity for hearing to the applicant, issue
an order withdrawing approval of an application
filed pursuant to subsection (b) with respect to
any new animal drug if the Secretary finds—
(A) that experience or scientific data show
that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved or the condition of use
authorized under subsection (a)(4)(A);
(B) that new evidence not contained in such
application or not available to the Secretary
until after such application was approved, or
tests by new methods, or tests by methods not
deemed reasonably applicable when such application was approved, evaluated together with
the evidence available to the Secretary when
the application was approved, shows that such
drug is not shown to be safe for use under the
conditions of use upon the basis of which the
application was approved or that subparagraph
(I) of paragraph (1) of subsection (d) applies to
such drug;
(C) on the basis of new information before
him with respect to such drug, evaluated together with the evidence available to him
when the application was approved, that there
is a lack of substantial evidence that such
drug will have the effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the
labeling thereof;
(D) the patent information prescribed by
subsection (c)(3) was not filed within 30 days
after the receipt of written notice from the
Secretary specifying the failure to file such information;
(E) that the application contains any untrue
statement of a material fact; or
(F) 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 drug 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 to suspend the approval of an application
shall not be delegated.
(2) 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 new animal drug
under this section if the Secretary finds—
(A) that the applicant has failed to establish
a system for maintaining required records, or

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TITLE 21—FOOD AND DRUGS

has repeatedly or deliberately failed to maintain such records or to make required reports
in accordance with a regulation or order under
subsection (l), or the applicant has refused to
permit access to, or copying or verification of,
such records as required by paragraph (2) of
such subsection;
(B) that on the basis of new information before him, evaluated together with the evidence
before him when the application was approved,
the methods used in, or the facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate
within a reasonable time after receipt of written notice from the Secretary specifying the
matter complained of; or
(C) 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 drug, 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.
(3) Any order under this subsection shall state
the findings upon which it is based.
(f) Revocation of order refusing, withdrawing or
suspending approval of application
Whenever the Secretary finds that the facts so
require, he shall revoke any previous order
under subsection (d), (e), or (m), or section
360ccc(c), (d), or (e) of this title refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate.
(g) Service of orders
Orders of the Secretary issued under this section, or section 360ccc of this title (other than
orders issuing, amending, or repealing regulations) shall be served (1) in person by any officer
or employee of the department designated by
the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to
the applicant or respondent at his last known
address in the records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from
an order of the Secretary refusing or withdrawing approval of an application filed under
subsection (b) or (m) of this section. The provisions of subsection (h) of section 355 of this title
shall govern any such appeal.
(i) Publication in Federal Register; effective date
and revocation or suspension of regulation
When a new animal drug application filed pursuant to subsection (b) or section 360ccc of this
title is approved, the Secretary shall by notice,
which upon publication shall be effective as a
regulation, publish in the Federal Register the
name and address of the applicant and the conditions and indications of use of the new animal
drug covered by such application, including any
tolerance and withdrawal period or other use restrictions and, if such new animal drug is intended for use in animal feed, appropriate pur-

§ 360b

poses and conditions of use (including special labeling requirements and any requirement that
an animal feed bearing or containing the new
animal drug be limited to use under the professional supervision of a licensed veterinarian) applicable to any animal feed for use in which such
drug is approved, and such other information,
upon the basis of which such application was approved, as the Secretary deems necessary to assure the safe and effective use of such drug.
Upon withdrawal of approval of such new animal
drug application or upon its suspension or upon
failure to renew a conditional approval under
section 360ccc of this title, the Secretary shall
forthwith revoke or suspend, as the case may be,
the regulation published pursuant to this subsection (i) insofar as it is based on the approval
of such application.
(j) Exemption of drugs for research; discretionary and mandatory conditions
To the extent consistent with the public
health, the Secretary shall promulgate regulations for exempting from the operation of this
section new animal drugs, and animal feeds
bearing or containing new animal drugs, intended solely for investigational use by experts
qualified by scientific training and experience to
investigate the safety and effectiveness of animal drugs. Such regulations may, in the discretion of the Secretary, among other conditions
relating to the protection of the public health,
provide for conditioning such exemption upon
the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor
of the investigation of such article, of data (including but not limited to analytical reports by
investigators) obtained as a result of such investigational use of such article, as the Secretary
finds will enable him to evaluate the safety and
effectiveness of such article in the event of the
filing of an application pursuant to this section.
Such regulations, among other things, shall set
forth the conditions (if any) upon which animals
treated with such articles, and any products of
such animals (before or after slaughter), may be
marketed for food use.
(k) Food containing new animal drug considered
unadulterated while approval of application
for such drug is effective
While approval of an application for a new animal drug is effective, a food shall not, by reason
of bearing or containing such drug or any substance formed in or on the food because of its
use in accordance with such application (including the conditions and indications of use prescribed pursuant to subsection (i)), be considered
adulterated within the meaning of clause (1) of
section 342(a) of this title.
(l) Records and reports; required information;
regulations and orders; examination of data;
access to records
(1) In the case of any new animal drug for
which an approval of an application filed pursuant to subsection (b) or section 360ccc of this
title is in effect, the applicant shall establish
and maintain such records, and make such reports to the Secretary, of data relating to experience, including experience with uses author-

§ 360b

TITLE 21—FOOD AND DRUGS

ized under subsection (a)(4)(A), 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.
(3)(A) In the case of each new animal drug described in paragraph (1) that contains an antimicrobial active ingredient, the sponsor of the
drug shall submit an annual report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled
product.
(B) Each report under this paragraph shall
specify the amount of each antimicrobial active
ingredient—
(i) by container size, strength, and dosage
form;
(ii) by quantities distributed domestically
and quantities exported; and
(iii) by dosage form, including, for each such
dosage form, a listing of the target animals,
indications, and production classes that are
specified on the approved label of the product.
(C) Each report under this paragraph shall—
(i) be submitted not later than March 31
each year;
(ii) cover the period of the preceding calendar year; and
(iii) include separate information for each
month of such calendar year.
(D) The Secretary may share information reported under this paragraph with the Antimicrobial Resistance Task Force established
under section 247d–5 of title 42.
(E) The Secretary shall make summaries of
the information reported under this paragraph
publicly available, except that—
(i) the summary data shall be reported by
antimicrobial class, and no class with fewer
than 3 distinct sponsors of approved applications shall be independently reported; and
(ii) the data shall be reported in a manner
consistent with protecting both national security and confidential business information.
(m) Feed mill licenses
(1) Any person may file with the Secretary an
application for a license to manufacture animal

Page 306

feeds bearing or containing new animal drugs.
Such person shall submit to the Secretary as
part of the application (A) a full statement of
the business name and address of the specific facility at which the manufacturing is to take
place and the facility’s registration number, (B)
the name and signature of the responsible individual or individuals for that facility, (C) a certification that the animal feeds bearing or containing new animal drugs are manufactured and
labeled in accordance with the applicable regulations published pursuant to subsection (i) or
for indexed new animal drugs in accordance with
the index listing published pursuant to section
360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of
this title, and (D) a certification that the methods used in, and the facilities and controls used
for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity
with current good manufacturing practice as described in section 351(a)(2)(B) of this title.
(2) Within 90 days after the filing of an application pursuant to paragraph (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall (A)
issue an order approving the application if the
Secretary 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)(1).
(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and
giving the applicant an opportunity for a hearing in accordance with such paragraph, finds, on
the basis of information submitted to the Secretary as part of the application, on the basis of
a preapproval inspection, or on the basis of any
other information before the Secretary—
(A) that the application is incomplete, false,
or misleading in any particular;
(B) 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
(C) that the facility manufactures animal
feeds bearing or containing new animal drugs
in a manner that does not accord with the
specifications for manufacture or labels animal feeds bearing or containing new animal
drugs in a manner that does not accord with
the conditions or indications of use that are
published pursuant to subsection (i) or an
index listing pursuant to section 360ccc–1(e) of
this title,
the Secretary shall issue an order refusing to
approve the application. If, after such notice and
opportunity for hearing, the Secretary finds
that subparagraphs (A) through (C) do not apply,
the Secretary shall issue an order approving the
application. An order under this subsection approving an application for a license to manufacture animal feeds bearing or containing new animal drugs shall permit a facility to manufacture

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TITLE 21—FOOD AND DRUGS

only those animal feeds bearing or containing
new animal drugs for which there are in effect
regulations pursuant to subsection (i) or an
index listing pursuant to section 360ccc–1(e) of
this title relating to the use of such drugs in or
on such animal feed.
(4)(A) The Secretary shall, after due notice
and opportunity for hearing to the applicant, revoke a license to manufacture animal feeds
bearing or containing new animal drugs under
this subsection if the Secretary finds—
(i) that the application for such license contains any untrue statement of a material fact;
or
(ii) that the applicant has made changes
that would cause the application to contain
any untrue statements of material fact or that
would affect the safety or effectiveness of the
animal feeds manufactured at the facility unless the applicant 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.
If the Secretary (or in the Secretary’s absence
the officer acting as the Secretary) finds that
there is an imminent hazard to the health of humans or of the animals for which such animal
feed is intended, the Secretary may suspend the
license immediately, and give the applicant
prompt notice of the 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, revoke a license to manufacture 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 section
354(a)(3)(A) of this title, or the applicant has
refused to permit access to, or copying or
verification of, such records as required by
subparagraph (B) of such paragraph or section
354(a)(3)(B) of this title;
(ii) that on the basis of new information before the Secretary, evaluated together with
the evidence before the Secretary when such
license was issued, the methods used in, or the
facilities and controls used for, the manufacture, processing, packing, and holding 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;
(iii) that on the basis of new information before the Secretary, evaluated together with
the evidence before the Secretary when such
license was issued, the labeling of any animal
feeds, 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; or

§ 360b

(iv) that on the basis of new information before the Secretary, evaluated together with
the evidence before the Secretary when such
license was issued, the facility has manufactured, processed, packed, or held animal feed
bearing or containing a new animal drug adulterated under section 351(a)(6) of this title and
the facility did not discontinue the manufacture, processing, packing, or holding of such
animal feed within a reasonable time after receipt of written notice from the Secretary
specifying the matter complained of.
(C) The Secretary may also revoke a license to
manufacture animal feeds under this subsection
if an applicant gives notice to the Secretary of
intention to discontinue the manufacture of all
animal feed covered under this subsection and
waives an opportunity for a hearing on the matter.
(D) Any order under this paragraph shall state
the findings upon which it is based.
(5) When a license to manufacture animal
feeds bearing or containing new animal drugs
has been issued—
(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); and
(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.
(6) To the extent consistent with the public
health, the Secretary may promulgate regulations for exempting from the operation of this
subsection facilities that manufacture, process,
pack, or hold animal feeds bearing or containing
new animal drugs.
(n) Abbreviated applications for new animal
drugs; contents, filing, etc.; lists of approved
drugs
(1) An abbreviated application for a new animal drug shall contain—
(A)(i) except as provided in clause (ii), information to show that the conditions of use or
similar limitations (whether in the labeling or
published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have
been previously approved for a new animal
drug listed under paragraph (4) (hereinafter in
this subsection referred to as an ‘‘approved
new animal drug’’), and
(ii) information to show that the withdrawal
period at which residues of the new animal
drug will be consistent with the tolerances established for the approved new animal drug is

§ 360b

TITLE 21—FOOD AND DRUGS

the same as the withdrawal period previously
established for the approved new animal drug
or, if the withdrawal period is proposed to be
different, information showing that the residues of the new animal drug at the proposed
different withdrawal period will be consistent
with the tolerances established for the approved new animal drug;
(B)(i) information to show that the active
ingredients of the new animal drug are the
same as those of the approved new animal
drug, and
(ii) if the approved new animal drug has
more than one active ingredient, and if one of
the active ingredients of the new animal drug
is different from one of the active ingredients
of the approved new animal drug and the application is filed pursuant to the approval of a
petition filed under paragraph (3)—
(I) information to show that the other active ingredients of the new animal drug are
the same as the active ingredients of the approved new animal drug,
(II) information to show either that the
different active ingredient is an active ingredient of another approved new animal drug
or of an animal drug which does not meet
the requirements of section 321(v) of this
title, and
(III) such other information respecting the
different active ingredients as the Secretary
may require;
(C)(i) if the approved new animal drug is permitted to be used with one or more animal
drugs in animal feed, information to show that
the proposed uses of the new animal drug with
other animal drugs in animal feed are the
same as the uses of the approved new animal
drug, and
(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other
animal drugs proposed for use with the new
animal drug in animal feed is different from
one of the other animal drugs permitted to be
used in animal feed with the approved new
animal drug, and the application is filed pursuant to the approval of a petition filed under
paragraph (3)—
(I) information to show either that the different animal drug proposed for use with the
approved new animal drug in animal feed is
an approved new animal drug permitted to
be used in animal feed or does not meet the
requirements of section 321(v) of this title
when used with another animal drug in animal feed,
(II) information to show that other animal
drugs proposed for use with the new animal
drug in animal feed are the same as the
other animal drugs permitted to be used
with the approved new animal drug, and
(III) such other information respecting the
different animal drug or combination with
respect to which the petition was filed as the
Secretary may require,
(D) information to show that the route of administration, the dosage form, and the
strength of the new animal drug are the same
as those of the approved new animal drug or,

Page 308

if the route of administration, the dosage
form, or the strength of the new animal drug
is different and the application is filed pursuant to the approval of a petition filed under
paragraph (3), such information respecting the
route of administration, dosage form, or
strength with respect to which the petition
was filed as the Secretary may require;
(E) information to show that the new animal
drug is bioequivalent to the approved new animal drug, except that if the application is filed
pursuant to the approval of a petition filed
under paragraph (3) for the purposes described
in subparagraph (B) or (C), information to
show that the active ingredients of the new
animal drug are of the same pharmacological
or therapeutic class as the pharmacological or
therapeutic class of the approved new animal
drug and that the new animal drug can be expected to have the same therapeutic effect as
the approved new animal drug when used in
accordance with the labeling;
(F) information to show that the labeling
proposed for the new animal drug is the same
as the labeling approved for the approved new
animal drug except for changes required because of differences approved under a petition
filed under paragraph (3), because of a different withdrawal period, or because the new
animal drug and the approved new animal
drug are produced or distributed by different
manufacturers;
(G) the items specified in clauses (B)
through (F) of subsection (b)(1);
(H) a certification, in the opinion of the applicant and to the best of his knowledge, with
respect to each patent which claims the approved new animal drug or which claims a use
for such approved new animal drug for which
the applicant is seeking approval under this
subsection and for which information is required to be filed under subsection (b)(1) or
(c)(3)—
(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 animal drug for which the application is filed; and
(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the
applicant is seeking approval of an application
under subsection (c)(2), a statement that the
method of use patent does not claim such a
use.
The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A)
through (I).
(2)(A) An applicant who makes a certification
described in paragraph (1)(G)(iv) shall include in
the application a statement that the applicant
will give the notice required by subparagraph
(B) to—
(i) each owner of the patent which is the subject of the certification or the representative

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of such owner designated to receive such notice, and
(ii) the holder of the approved application
under subsection (c)(1) for the drug which is
claimed by the patent or a use of which is
claimed by the patent or the representative of
such holder designated to receive such notice.
(B) The notice referred to in subparagraph (A)
shall state that an application, which contains
data from bioequivalence studies, has been filed
under this subsection for the drug with respect
to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed
statement of the factual and legal basis of the
applicant’s opinion that the patent is not valid
or will not be infringed.
(C) If an application is amended to include a
certification described in paragraph (1)(G)(iv),
the notice required by subparagraph (B) shall be
given when the amended application is filed.
(3) If a person wants to submit an abbreviated
application for a new animal drug—
(A) whose active ingredients, route of administration, dosage form, or strength differ
from that of an approved new animal drug, or
(B) whose use with other animal drugs in
animal feed differs from that of an approved
new animal drug,
such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve a petition
for a new animal drug unless the Secretary finds
that—
(C) investigations must be conducted to
show the safety and effectiveness, in animals
to be treated with the drug, of the active ingredients, route of administration, dosage
form, strength, or use with other animal drugs
in animal feed which differ from the approved
new animal drug, or
(D) investigations must be conducted to
show the safety for human consumption of any
residues in food resulting from the proposed
active ingredients, route of administration,
dosage form, strength, or use with other animal drugs in animal feed for the new animal
drug which is different from the active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in
animal feed of the approved new animal drug.
The Secretary shall approve or disapprove a petition submitted under this paragraph within 90
days of the date the petition is submitted.
(4)(A)(i) Within 60 days of November 16, 1988,
the Secretary shall publish and make available
to the public a list in alphabetical order of the
official and proprietary name of each new animal drug which has been approved for safety and
effectiveness before November 16, 1988.
(ii) Every 30 days after the publication of the
first list under clause (i) the Secretary shall revise the list to include each new animal drug
which has been approved for safety and effectiveness under subsection (c) during the 30 day
period.
(iii) When patent information submitted under
subsection (b)(1) or (c)(3) respecting a new ani-

§ 360b

mal drug included on the list is to be published
by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug.
(B) A new animal drug approved for safety and
effectiveness before November 16, 1988, or approved for safety and effectiveness under subsection (c) shall, for purposes of this subsection,
be considered to have been published under subparagraph (A) on the date of its approval or November 16, 1988, whichever is later.
(C) If the approval of a new animal drug was
withdrawn or suspended under subsection
(c)(2)(G) or for grounds described in subsection
(e) or if the Secretary determines that a drug
has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the
list under subparagraph (A) or, if the withdrawal
or suspension occurred after its publication in
such list, it shall be immediately removed from
such list—
(i) for the same period as the withdrawal or
suspension under subsection (c)(2)(G) or (e), or
(ii) if the listed drug has been withdrawn
from sale, for the period of withdrawal from
sale or, if earlier, the period ending on the
date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons.
A notice of the removal shall be published in the
Federal Register.
(5) If an application contains the information
required by clauses (A), (G), and (H) of subsection (b)(1) and such information—
(A) is relied on by the applicant for the approval of the application, and
(B) is not information derived either from
investigations, studies, or tests conducted by
or for the applicant or for which the applicant
had obtained a right of reference or use from
the person by or for whom the investigations,
studies, or tests were conducted,
such application shall be considered to be an application filed under subsection (b)(2).
(o) ‘‘Patent’’ defined
For purposes of this section, the term ‘‘patent’’ means a patent issued by the United States
Patent and Trademark Office.
(p) Safety and effectiveness data
(1) Safety and effectiveness data and information which has been submitted in an application
filed under subsection (b)(1) or section 360ccc(a)
of this title for a drug and which has not previously been disclosed to the public shall be
made available to the public, upon request, unless extraordinary circumstances are shown—
(A) if no work is being or will be undertaken
to have the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals have been exhausted,
(C) if approval of the application under subsection (c) is withdrawn and all legal appeals
have been exhausted,
(D) if the Secretary has determined that
such drug is not a new drug, or
(E) upon the effective date of the approval of
the first application filed under subsection
(b)(2) which refers to such drug or upon the

§ 360b

TITLE 21—FOOD AND DRUGS

date upon which the approval of an application filed under subsection (b)(2) which refers
to such drug could be made effective if such an
application had been filed.
(2) Any request for data and information pursuant to paragraph (1) shall include a verified
statement by the person making the request
that any data or information received under
such paragraph shall not be disclosed by such
person to any other person—
(A) for the purpose of, or as part of a plan,
scheme, or device for, obtaining the right to
make, use, or market, or making, using, or
marketing, outside the United States, the
drug identified in the application filed under
subsection (b)(1) or section 360ccc(a) of this
title, and
(B) without obtaining from any person to
whom the data and information are disclosed
an identical verified statement, a copy of
which is to be provided by such person to the
Secretary, which meets the requirements of
this paragraph.
(q) Date of approval in the case of recommended
controls under the CSA
(1) In general
In the case of an application under subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that
the Secretary intends to issue a scientific and
medical evaluation and recommend controls
under the Controlled Substances Act [21 U.S.C.
801 et seq.], approval of such application shall
not take effect until the interim final rule
controlling the drug is issued in accordance
with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
(2) Date of approval
For purposes of this section, with respect to
an application described in paragraph (1), the
term ‘‘date of approval’’ shall mean the later
of—
(A) the date an application under subsection (b) is approved under subsection (c);
or
(B) the date of issuance of the interim
final rule controlling the drug.
(June 25, 1938, ch. 675, § 512, as added Pub. L.
90–399, § 101(b), July 13, 1968, 82 Stat. 343; amended Pub. L. 100–670, title I, §§ 101, 102, 104, 107(a)(2),
Nov. 16, 1988, 102 Stat. 3971, 3981, 3982, 3984; Pub.
L. 102–108, § 2(e), Aug. 17, 1991, 105 Stat. 550; Pub.
L. 103–80, § 3(r), Aug. 13, 1993, 107 Stat. 777; Pub.
L. 103–396, § 2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat.
4153, 4154; Pub. L. 104–250, §§ 2(a)–(d), 3, 4, 5(c),
6(a), (b), Oct. 9, 1996, 110 Stat. 3151–3153, 3155–3157;
Pub. L. 105–115, title I, § 124(b), Nov. 21, 1997, 111
Stat. 2325; Pub. L. 105–277, div. A, § 101(a) [title
VII, § 737], Oct. 21, 1998, 112 Stat. 2681, 2681–30;
Pub. L. 106–113, div. B, § 1000(a)(9) [title IV,
§ 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536,
1501A–584; Pub. L. 108–282, title I, § 102(b)(2), (3),
(5)(I)–(S), Aug. 2, 2004, 118 Stat. 892, 903, 904; Pub.
L. 110–316, title I, § 105(a), Aug. 14, 2008, 122 Stat.
3513; Pub. L. 114–89, § 2(a)(3)(A), Nov. 25, 2015, 129
Stat. 699; Pub. L. 114–255, div. A, title III,
§ 3088(b), Dec. 13, 2016, 130 Stat. 1149; Pub. L.
115–234, title III, § 301(a), Aug. 14, 2018, 132 Stat.

Page 310

2436; Pub. L. 117–9, § 1(a)(2), Apr. 23, 2021, 135
Stat. 257.)
Editorial Notes
REFERENCES IN TEXT
Section 342(a)(2) of this title, referred to in subsec.
(a)(6), was amended by Pub. L. 104–170, title IV, § 404,
Aug. 3, 1996, 110 Stat. 1514, and, as so amended, no
longer contains a subcl. (D). See section 342(a)(2)(C)(ii)
of this title.
The Controlled Substances Act, referred to in subsec.
(q)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat.
1242, which is classified principally to subchapter I
(§ 801 et seq.) of chapter 13 of this title. For complete
classification of this Act to the Code, see Short Title
note set out under section 801 of this title and Tables.
AMENDMENTS
2021—Subsec. (c)(2)(F). Pub. L. 117–9 substituted ‘‘active moiety (as defined by the Secretary in section 314.3
of title 21, Code of Federal Regulations (or any successor regulations))’’ for ‘‘active ingredient (including
any ester or salt of the active ingredient)’’ in cls. (i),
(ii), and (v).
2018—Subsec. (b)(4). Pub. L. 115–234 added par. (4).
2016—Subsec. (a)(1)(D). Pub. L. 114–255 added subpar.
(D).
2015—Subsec. (q). Pub. L. 114–89 added subsec. (q).
2008—Subsec. (l)(3). Pub. L. 110–316 added par. (3).
2004—Subsec. (a)(1), (2). Pub. L. 108–282, § 102(b)(5)(I),
added pars. (1) and (2) and struck out former pars. (1)
and (2) which deemed as unsafe new animal drugs and
animal feed bearing or containing a new animal drug
which did not have in effect certain approvals.
Subsec. (b)(3). Pub. L. 108–282, § 102(b)(5)(J), substituted ‘‘under paragraph (1), section 360ccc of this
title, or a request for an investigational exemption
under subsection (j)’’ for ‘‘under paragraph (1) or a request for an investigational exemption under subsection (j)’’.
Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108–282,
§ 102(b)(2), substituted ‘‘(other than bioequivalence
studies or residue depletion studies, except residue depletion studies for minor uses or minor species)’’ for
‘‘(other than bioequivalence or residue studies)’’.
Subsec. (d)(4). Pub. L. 108–282, § 102(b)(5)(K), substituted ‘‘have previously been separately approved
pursuant to an application submitted under subsection
(b)(1)’’ for ‘‘have previously been separately approved’’
in introductory provisions.
Subsec. (d)(5). Pub. L. 108–282, § 102(b)(3), added par.
(5).
Subsec. (f). Pub. L. 108–282, § 102(b)(5)(L), substituted
‘‘subsection (d), (e), or (m), or section 360ccc(c), (d), or
(e) of this title’’ for ‘‘subsection (d), (e), or (m)’’.
Subsec. (g). Pub. L. 108–282, § 102(b)(5)(M), substituted
‘‘this section, or section 360ccc of this title’’ for ‘‘this
section’’.
Subsec. (i). Pub. L. 108–282, § 102(b)(5)(N), substituted
‘‘subsection (b) or section 360ccc of this title’’ for ‘‘subsection (b)’’ and inserted ‘‘or upon failure to renew a
conditional approval under section 360ccc of this title’’
after ‘‘or upon its suspension’’.
Subsec. (l)(1). Pub. L. 108–282, § 102(b)(5)(O), substituted ‘‘subsection (b) or section 360ccc of this title’’
for ‘‘subsection (b)’’.
Subsec. (m)(1)(C). Pub. L. 108–282, § 102(b)(5)(P), substituted ‘‘applicable regulations published pursuant to
subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to
section 360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of this title’’
for ‘‘applicable regulations published pursuant to subsection (i)’’.
Subsec. (m)(3). Pub. L. 108–282, § 102(b)(5)(Q), inserted
‘‘or an index listing pursuant to section 360ccc–1(e) of
this title’’ after ‘‘subsection (i)’’ in subpar. (C) and concluding provisions.

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Subsec. (p)(1), (2)(A). Pub. L. 108–282, § 102(b)(5)(R), (S),
substituted ‘‘subsection (b)(1) or section 360ccc(a) of
this title’’ for ‘‘subsection (b)(1)’’.
1999—Subsec. (o). Pub. L. 106–113 substituted ‘‘United
States Patent and Trademark Office’’ for ‘‘Patent and
Trademark Office of the Department of Commerce’’.
1998—Subsec. (d)(4)(D)(iii). Pub. L. 105–277 inserted before semicolon ‘‘, except that for purposes of this
clause, antibacterial ingredient or animal drug does
not include the ionophore or arsenical classes of animal
drugs’’.
1997—Subsec. (c)(4). Pub. L. 105–115 added par. (4).
1996—Subsec. (a)(1). Pub. L. 104–250, § 6(a), amended
par. (1) generally. Prior to amendment, par. (1) read as
follows: ‘‘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 351(a)(5) and section
342(a)(2)(D) of this title unless—
‘‘(A) there is in effect an approval of an application
filed pursuant to subsection (b) of this section with
respect to such use or intended use of such drug, and
‘‘(B) such drug, its labeling, and such use conform
to such approved application.
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.’’
Subsec. (a)(2). Pub. L. 104–250, § 6(a), amended par. (2)
generally. Prior to amendment, par. (2) read as follows:
‘‘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 351(a)(6) of this title unless—
‘‘(A) there is in effect an approval of an application
filed pursuant to subsection (b) of this section with
respect to such drugs, 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 and
to the application with respect thereto approved
under subsection (m) of this section.’’
Subsec. (a)(6). Pub. L. 104–250, § 4, added par. (6).
Subsec. (b)(3). Pub. L. 104–250, § 2(d), added par. (3).
Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104–250, § 2(b)(1), substituted ‘‘substantial evidence of the effectiveness of
the drug involved, any studies of animal safety, or,’’ for
‘‘reports of new clinical or field investigations (other
than bioequivalence or residue studies) and,’’ and ‘‘required for the approval’’ for ‘‘essential to the approval’’.
Subsec. (c)(2)(F)(v). Pub. L. 104–250, § 2(b)(2), substituted ‘‘clause (iv)’’ for ‘‘subparagraph (B)(iv)’’ in two
places, ‘‘substantial evidence of the effectiveness of the
drug involved, any studies of animal safety,’’ for ‘‘reports of clinical or field investigations’’ and ‘‘required
for the new approval’’ for ‘‘essential to the new approval’’.
Subsec. (d)(1)(F). Pub. L. 104–250, § 3, amended subpar.
(F) generally. Prior to amendment, subpar. (F) read as
follows: ‘‘upon the basis of the information submitted
to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended;’’.
Subsec. (d)(3). Pub. L. 104–250, § 2(a), amended par. (3)
generally. Prior to amendment, par. (3) read as follows:

§ 360b

‘‘As used in this subsection and subsection (e) of this
section, the term ‘substantial evidence’ means evidence
consisting of adequate and well-controlled investigations, including field investigation, by experts qualified
by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which
it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or
is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or
proposed labeling thereof.’’
Subsec. (d)(4). Pub. L. 104–250, § 2(c), added par. (4).
Subsec. (i). Pub. L. 104–250, § 5(c), inserted ‘‘and any
requirement that an animal feed bearing or containing
the new animal drug be limited to use under the professional supervision of a licensed veterinarian’’ after
‘‘(including special labeling requirements’’.
Subsec. (m). Pub. L. 104–250, § 6(b), amended subsec.
(m) generally, substituting provisions relating to application for feed mill licenses, including approval, refusal, revocation, and suspension of such licenses, and
provisions for record and reporting requirements for, as
well as exemption from, such licenses, for provisions
relating to application for uses of animal feed containing new animal drug, including required contents,
approval, refusal, and withdrawal of approval or suspension of such usage applications, and provisions for
record and reporting requirements of such usage applications.
1994—Subsec. (a)(4), (5). Pub. L. 103–396, § 2(a), added
pars. (4) and (5).
Subsec. (e)(1)(A). Pub. L. 103–396, § 2(b)(2), inserted before semicolon at end ‘‘or the condition of use authorized under subsection (a)(4)(A)’’.
Subsec. (l)(1). Pub. L. 103–396, § 2(b)(3), substituted
‘‘relating to experience, including experience with uses
authorized under subsection (a)(4)(A),’’ for ‘‘relating to
experience’’.
1993—Subsec. (c)(2)(A)(ii). Pub. L. 103–80, § 3(r)(1), inserted ‘‘in’’ after ‘‘except as provided’’.
Subsec. (c)(2)(F)(i). Pub. L. 103–80, § 3(r)(2), substituted
‘‘subparagraph (D)(iii)’’ for ‘‘subparagraph (C)(iii)’’.
Subsec. (c)(2)(H)(ii). Pub. L. 103–80, § 3(r)(3), substituted ‘‘subclauses’’ for ‘‘subclause’’ after ‘‘bioequivalency information described in’’ in concluding provisions.
Subsec. (d)(1). Pub. L. 103–80, § 3(r)(4), substituted
‘‘subparagraphs (A) through (I)’’ for ‘‘subparagraphs (A)
through (G)’’ in concluding provisions.
Subsec. (n)(1). Pub. L. 103–80, § 3(r)(5), substituted
‘‘section 321(v) of this title’’ for ‘‘section 321(w) of this
title’’ in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted ‘‘through (I)’’ for ‘‘through (H)’’ in concluding
provisions.
1991—Subsec. (e)(1)(B). Pub. L. 102–108 substituted
‘‘(I)’’ for ‘‘(H)’’.
1988—Subsec. (a)(1)(C). Pub. L. 100–670, § 107(a)(2),
struck out subpar. (C) which read as follows: ‘‘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) of this section
is in effect with respect to such drug.’’
Subsec. (b). Pub. L. 100–670, §§ 101(a), 102(a), designated
existing provisions as par. (1), redesignated cls. (1) to
(8) as cls. (A) to (H), respectively, added par. (2), and inserted provisions at end of par. (1) which require applicant to file with application, patent number and expiration date of any patent which claims new animal
drug, to amend application to include such information
if patent which claims such drug or method of using
such drug is issued after filing date but before approval
of application, and to publish such information upon
approval.
Subsec. (c). Pub. L. 100–670, §§ 101(c), 102(b)(1), designated existing provisions as par. (1), redesignated cls.
(1) and (2) as cls. (A) and (B), respectively, and added
pars. (2) and (3).
Subsec. (d)(1). Pub. L. 100–670, § 102(b)(3), substituted
‘‘(G)’’ for ‘‘(H)’’ in last sentence.

§ 360b

TITLE 21—FOOD AND DRUGS

Subsec. (d)(1)(G) to (I). Pub. L. 100–670, § 102(b)(2),
added subpar. (G) and redesignated former subpars. (G)
and (H) as (H) and (I), respectively.
Subsec. (e)(1)(D) to (F). Pub. L. 100–670, § 102(b)(4),
added subpar. (D) and redesignated former subpars. (D)
and (E) as (E) and (F), respectively.
Subsecs. (n), (o). Pub. L. 100–670, § 101(b), added subsecs. (n) and (o) and struck out former subsec. (n) which
related to certification of new drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, and release prior to certification.
Subsec. (p). Pub. L. 100–670, § 104, added subsec. (p).
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1999 AMENDMENT
Amendment by Pub. L. 106–113 effective 4 months
after Nov. 29, 1999, see section 1000(a)(9) [title IV, § 4731]
of Pub. L. 106–113, set out as a note under section 1 of
Title 35, Patents.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105–115 effective 90 days after
Nov. 21, 1997, except as otherwise provided, see section
501 of Pub. L. 105–115, set out as a note under section 321
of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Pub. L. 103–396, § 2(d), Oct. 22, 1994, 108 Stat. 4154, provided that: ‘‘The amendments made by this section
[amending this section and section 331 of this title]
shall take effect upon the adoption of the final regulations under subsection (c) [set out below].’’ [Final regulations were dated Oct. 22, 1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61 F.R. 57732, and effective Dec. 9,
1996.]
EFFECTIVE DATE OF 1988 AMENDMENT
Pub. L. 100–670, title I, § 108, Nov. 16, 1988, 102 Stat.
3984, provided that: ‘‘The Secretary of Health and
Human Services may not make an approval of an application submitted under section 512(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991.’’
EFFECTIVE DATE AND TRANSITIONAL PROVISIONS
Pub. L. 90–399, § 108, July 13, 1968, 82 Stat. 353, as
amended by Pub. L. 108–282, title I, § 102(b)(5)(T), Aug. 2,
2004, 118 Stat. 905, provided that:
‘‘(a) Except as otherwise provided in this section, the
amendments made by the foregoing sections [see Short
Title of 1968 Amendment note set out under section 301
of this title] shall take effect on the first day of the
thirteenth calendar month which begins after the date
of enactment of this Act [July 13, 1968].
‘‘(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 [this chapter]; 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 regulations, shall continue
in effect, and shall be subject to change in accordance
with the provisions of the basic Act as amended by this
Act [see Short Title of 1968 Amendment note set out
under section 301 of this title].
‘‘(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) [subsection (n) of this section] 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

Page 312

basic Act [section 321(p) of this title] as then in force,
and (C) was not covered by an effective application
under section 505 of that Act [section 355 of this title],
the words ‘effectiveness’ and ‘effective’ contained in
section 201(v) to the basic Act [sic] [section 321(v) of
this title] 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 [section 357 of this title] shall, except as the Secretary may otherwise prescribe, be deemed to apply
also under section 512(n) of the basic Act [subsection
(n) of this section], and appropriations of fees (and of
advance deposits to cover fees) available for the purposes specified in such section 507 [section 357 of this
title] as in effect prior to the effective date shall also
be available for the purposes specified in section 512(n)
[subsection (n) of this section], including preparatory
work or proceedings prior to that date.’’
REGULATIONS
Pub. L. 104–250, § 2(e), Oct. 9, 1996, 110 Stat. 3154, provided that:
‘‘(1) IN GENERAL.—Not later than 6 months after the
date of enactment of this Act [Oct. 9, 1996], the Secretary of Health and Human Services shall issue proposed regulations implementing the amendments made
by this Act as described in paragraph (2)(A) of this subsection, and not later than 18 months after the date of
enactment of this Act, the Secretary shall issue final
regulations implementing such amendments. Not later
than 12 months after the date of enactment of this Act,
the Secretary shall issue proposed regulations implementing the other amendments made by this Act as described in paragraphs (2)(B) and (2)(C) of this subsection, and not later than 24 months after the date of
enactment of this Act, the Secretary shall issue final
regulations implementing such amendments.
‘‘(2) CONTENTS.—In issuing regulations implementing
the amendments made by this Act [see Short Title of
1996 Amendments note set out under section 301 of this
title], and in taking an action to review an application
for approval of a new animal drug under section 512 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b), or a request for an investigational exemption for
a new animal drug under subsection (j) of such section,
that is pending or has been submitted prior to the effective date of the regulations, the Secretary shall—
‘‘(A) further define the term ‘adequate and well
controlled’, as used in subsection (d)(3) of section 512
of such Act, to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the
field and differences between field conditions and laboratory conditions;
‘‘(B) further define the term ‘substantial evidence’,
as defined in subsection (d)(3) of such section, in a
manner that encourages the submission of applications and supplemental applications; and
‘‘(C) take into account the proposals contained in
the citizen petition (FDA Docket No. 91P–0434/CP)
jointly submitted by the American Veterinary Medical Association and the Animal Health Institute,
dated October 21, 1991.
Until the regulations required by subparagraph (A) are
issued, nothing in the regulations published at 21
C.F.R. 514.111(a)(5) (April 1, 1996) shall be construed to
compel the Secretary of Health and Human Services to
require a field investigation under section 512(d)(1)(E)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(d)(1)(E)) or to apply any of its provisions in a manner inconsistent with the considerations for scientifically sound field investigations set forth in subparagraph (A).’’
Pub. L. 103–396, § 2(c), Oct. 22, 1994, 108 Stat. 4154, provided that: ‘‘Not later than 2 years after the date of the

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TITLE 21—FOOD AND DRUGS

enactment of this Act [Oct. 22, 1994], the Secretary of
Health and Human Services shall promulgate regulations to implement paragraphs (4)(A) and (5) of section
512(a) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360b(a)(4)(A), (5)] (as amended by subsection
(a)).’’
Pub. L. 100–670, title I, § 103, Nov. 16, 1988, 102 Stat.
3982, provided that:
‘‘(a) GENERAL RULE.—The Secretary of Health and
Human Services shall promulgate, in accordance with
the notice and comment requirements of section 553 of
title 5, United States Code, such regulations as may be
necessary for the administration of section 512 of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b],
as amended by sections 101 through 103 of this title,
within one year of the date of enactment of this Act
[Nov. 16, 1988].
‘‘(b) TRANSITION.—During the period beginning 60
days after the date of enactment of this Act [Nov. 16,
1988] and ending on the date regulations promulgated
under subsection (a) take effect, abbreviated new animal drug applications may be submitted in accordance
with the provisions of section 314.55 and part 320 of title
21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 512(c)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360b(c)] before the date of enactment of this Act. If any
such provision of section 314.55 or part 320 is inconsistent with the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by this
title), the Secretary shall consider the application
under the applicable requirements of section 512 (as so
amended).’’
GUIDANCE ADDRESSING INVESTIGATION DESIGNS
Pub. L. 115–234, title III, § 305, Aug. 14, 2018, 132 Stat.
2440, provided that:
‘‘(a) IN GENERAL.—For purposes of assisting sponsors
in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real
world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this
section as ‘elements of investigations’) into proposed
clinical investigation protocols and applications for
new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b;
360ccc), the Secretary of Health and Human Services
(referred to in this section as the ‘Secretary’) shall
issue guidance addressing the use of such elements of
investigations in the development and regulatory review of such new animal drugs.
‘‘(b) CONTENTS.—The guidance under subsection (a)
shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug,
and Cosmetic Act or to meet the commitment under
section 571(a)(2)(F) of such Act, and how sponsors of
such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the
Secretary.
‘‘(c) MEETING.—Prior to issuing the guidance under
subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and
food producers, through a public meeting to be held not
later than 1 year after the date of enactment of this
Act [Aug. 14, 2018].
‘‘(d) TIMING.—The Secretary shall issue a draft guidance under subsection (a) not later than 1 year after
the date of the public meeting under subsection (c), and
shall finalize such guidance not later than 1 year after
the date on which the public comment period on such
draft guidance ends.’’
ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORTS
Pub. L. 110–316, title I, § 105(b), (c), Aug. 14, 2008, 122
Stat. 3514, provided that:

§ 360b–1

‘‘(b) FIRST REPORT.—For each new animal drug that
is subject to the reporting requirement under section
512(l)(3) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 360b(l)(3)], as added by subsection (a), and for
which an approval of an application filed pursuant to
section 512(b) or 571 of such Act [21 U.S.C. 360b(b),
360ccc] is in effect on the date of the enactment of this
title [Aug. 14, 2008], the Secretary of Health and Human
Services shall require the sponsor of the drug to submit
the first report under such section 512(l)(3) for the drug
not later than March 31, 2010.
‘‘(c) SEPARATE REPORT.—The reports required under
section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall be separate
from periodic drug experience reports that are required
under section 514.80(b)(4) of title 21, Code of Federal
Regulations (as in effect on the date of the enactment
of this title).’’
DRUGS INTENDED FOR MINOR SPECIES AND MINOR USES
Pub. L. 104–250, § 2(f), Oct. 9, 1996, 110 Stat. 3154, provided that: ‘‘The Secretary of Health and Human Services shall consider legislative and regulatory options
for facilitating the approval under section 512 of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b]
of animal drugs intended for minor species and for
minor uses and, within 18 months after the date of enactment of this Act [Oct. 9, 1996], announce proposals
for legislative or regulatory change to the approval
process under such section for animal drugs intended
for use in minor species or for minor uses.’’
TRANSITIONAL PROVISION REGARDING IMPLEMENTATION
OF PUB. L. 104–250; APPROVED MEDICATED FEED APPLICATION DEEMED LICENSE
Pub. L. 104–250, § 6(c), Oct. 9, 1996, 110 Stat. 3160, provided that: ‘‘A person engaged in the manufacture of
animal feeds bearing or containing new animal drugs
who holds at least one approved medicated feed application for an animal feed bearing or containing new
animal drugs, the manufacture of which was not otherwise exempt from the requirement for an approved
medicated feed application on the date of the enactment of this Act [Oct. 9, 1996], shall be deemed to hold
a license for the manufacturing site identified in the
approved medicated feed application. The revocation of
license provisions of section 512(m)(4) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 360b(m)(4)], as
amended by this Act, shall apply to such licenses. Such
license shall expire within 18 months from the date of
enactment of this Act unless the person submits to the
Secretary a completed license application for the manufacturing site accompanied by a copy of an approved
medicated feed application for such site, which license
application shall be deemed to be approved upon receipt by the Secretary.’’
DRUGS PRIMARILY MANUFACTURED USING
BIOTECHNOLOGY
Pub. L. 100–670, title I, § 106, Nov. 16, 1988, 102 Stat.
3984, provided that: ‘‘Notwithstanding section 512(b)(2)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360b(b)(2)], the Secretary of Health and Human Services
may not approve an abbreviated application submitted
under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes
involving site specific genetic manipulation techniques.’’

§ 360b–1. Priority zoonotic animal drugs
(a) In general
The Secretary shall, at the request of the
sponsor intending to submit an application for
approval of a new animal drug under section
360b(b)(1) of this title or an application for conditional approval of a new animal drug under