108 STAT. 4154
PUBLIC LAW 103-396—(XTT. 22, 1994
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 505
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 502(f) 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-clientpatient 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.",
(b) OTHER AMENDMENTS. —
(1) SECTION 301.— Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended—
(A) in paragraph (e), by striking "507(d) or (g)," and
inserting "507(d) or (g), 512(a)(4)(C),"; and
(B) by adding at the end the following:
"(u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section
512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).".
(2) SECTION 512(e).—Section 512(e)(1)(A) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 360b(e)(l)(A)) is
amended by inserting before the semicolon the following: "or
the condition of use authorized under subsection (a)(4)(A)".
(3) SECTION 512(1).— Section 512(1)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(l)(l)) is amended by
striMng "relating to experience" and inserting "relating to
experience, including experience with uses authorized under
subsection (a)(4)(A),".
21 USC 360b
(c) REGULATIONS. —Not later than 2 years after the date of
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the enactment of this Act, 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 (as amended by subsection (a)).
21 USC 360b
(d) EFFECTIVE DATE.— The amendments made by this section
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shall take effect upon the adoption of the final regulations under
subsection (c).
SEC. 3. MAPLE SYRUP.
(a) PREEMPTION. — Section 403A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343-l(a)) is amended—
(1) in paragraph (1), by inserting at the end the following:
"except that this paragraph does not apply to a standard of
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