Text: H.R.5297 — 102nd Congress (1991-1992)All Information (Except Text)

There is one version of the bill.

Text available as:

Shown Here:
Introduced in House

 
 
HR 5297 IH
102d CONGRESS
2d Session
 H. R. 5297
Entitled the `Animal Medicinal Drug Use Clarification Act of 1992'.
IN THE HOUSE OF REPRESENTATIVES
May 28, 1992
Mr. STENHOLM (for himself, Mr. ALLARD, Mr. BARTON of Texas, Mr. BOEHNER,
Mr. BREWSTER, Mr. BROWN, Mr. CONDIT, Mr. CRAMER, Mr. DOOLEY, Mr. GLICKMAN,
Mr. GOODLING, Mr. GRANDY, Mr. GREEN of New York, Mr. GUNDERSON, Mr. HASTERT,
Mr. HATCHER, Mr. HERGER, Mr. HOPKINS, Mr. HUCKABY, Mr. JOHNSON of South
Dakota, Mr. JONTZ, Mr. MONTGOMERY, Mr. MORRISON, Mr. MYERS of Indiana,
Mr. NAGLE, Mr. NUSSLE, Mr. OXLEY, Mr. PENNY, Mr. PETERSON of Minnesota,
Mr. REGULA, Mr. ROBERTS, Mr. SARPALIUS, Mr. SMITH of Oregon, Mr. STALLINGS,
Mr. TOWNS, Mr. VOLKMER, and Mr. WALSH) introduced the following bill; which
was referred to the Committee on Energy and Commerce
A BILL
Entitled the `Animal Medicinal Drug Use Clarification Act of 1992'.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
SECTION 1. SHORT TITLE.
  This act may be cited as the `Animal Medicinal Drug Use Clarification Act
  of 1992'.
SEC. 2. FINDINGS.
  Congress finds that--
  (1) the Federal Food, Drug, and Cosmetic Act currently permits the use
  of an animal drug, or a drug intended for human use, that is approved by
  the Food and Drug Administration, only in accordance with the specific
  labeling approved for the drug;
  (2) there are not such approved animal drugs available to relieve pain
  and suffering, or to treat every specific disease or condition found,
  in each species of animal;
  (3) it is sometimes necessary for veterinarians to use such an approved
  animal drug or approved drug intended for human use in a manner that is
  not in accordance with the label of the drug if--
  (A) the health of an animal is immediately threatened; and
  (B) suffering or death would result from failure to provide effective
  treatment; and
  (4) duly licensed veterinarians possess the professional training and
  medical judgment to administer drugs in a clinically appropriate manner
  that benefits animals and safeguards the public health.
SEC. 3. PURPOSES.
  The purposes of this Act are--
  (1) to permit veterinarians to use such an approved animal drug, or
  approved drug intended for human use, for therapeutic purposes in animals
  in a manner that is not specified on the label of the drug, if a valid
  veterinarian-client-patient relationship exists; and
  (2) to permit the Secretary of Health and Human Services to establish
  conditions for such use as may be necessary to protect the public health.
SEC. 4. ALTERNATE USES.
  Section 512(a) of the Federal Food, Drug, and Cosmetic Act (21
  U.S.C. 360b(a)) is amended by adding at the end the following new paragraphs:
  `(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 section 501(a)(5), and shall be exempt
  from the requirements of section 502(f), with respect to a different use
  or intended use of the drug, 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 under
  subparagraph (C).
  `(B) Notwithstanding subparagraph (A), if the use of a new animal drug
  results in residues in food that the Secretary has determined to be in
  violation of established safe levels for such drug, such drug shall then be
  deemed unsafe for the purposes of section 501(a)(5), and shall be subject
  to the requirements of section 502(f).
  `(C) The Secretary shall implement final regulations that establish the
  conditions for the use or intended use of new animal drugs, as provided
  under this paragraph and as may be necessary to protect the public health,
  not later than one year after the enactment of this Act.
  `(5)(A) If an approval of an application filed under section 505 is in effect
  with respect to a particular use or intended use of a drug intended for
  human use, the drug shall not be deemed unsafe for the purposes of section
  501(a)(5), and shall be exempt from the requirements of section 502(f),
  with respect to a use or intended use of the drug in nonfood producing
  animals, 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 under
  subparagraph (B).
  `(B) The Secretary shall implement final regulations that establish the
  conditions for the use or intended use of human drugs, as provided under
  this paragraph and as may be necessary to protect the public health,
  not later than one year after the enactment of this Act.'.