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23.

Animal Drug Prosecutions -- Sample Indictment

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF IOWA

CENTRAL DIVISION

UNITED STATES OF AMERICA, ) No. ) Plaintiff, ) INDICTMENT ) v. ) 18 U.S.C. § 371 ) 21 U.S.C. § 331(c) ) 21 U.S.C. § 333(b) XXXX X. XXXXXXXX, ) [since July 22, 1988, ) has been recodified as Defendant. ) 21 U.S.C. 333(a)(2)] __________________________________)

THE GRAND JURY CHARGES:

COUNT 1 (Conspiracy)

Introductory Allegations

1. At all times relevant to this Indictment, the United States Food and Drug Administration (hereafter referred to as "FDA") was the agency of the United States charged with the responsibility of protecting the health and safety of the American public by ensuring, among other things, that drug products which were offered for use in animals (hereafter referred to as "animal drugs" or "animal drug products") were safe and effective for their intended uses and did not leave harmful residues in the meat, milk, or eggs of the animals treated with those drugs.

2. Animal drug products which do not possess the proper strength, quality, purity, or other essential characteristics may not be safe and effective in one or more of the following ways:

(1) the drug product may not effectively treat the disease condition for which it is used and thus harm the animal;

(2) the drug product may leave harmful residues in an animal's meat, milk, or eggs that are ultimately consumed by humans; and

(3) the drug product may be harmful to the treated animal or to humans who come in contact with the drug while it is being administered.

3. As used in this Indictment, "animal drugs" and "animal drug products" are drugs within the meaning of Title 21, United States Code, Section 321(g)(1).

4. At all times relevant to this Indictment, the Federal Food, Drug, and Cosmetic Act required that, prior to marketing, the sponsor of a new animal drug product establish that the drug product was safe and effective under specified conditions of production, formulation, labeling, and use. This was accomplished through the submission to FDA of comprehensive and well-controlled studies in support of a new animal application ("NADA"), which application then had to be approved by FDA before the new animal drug could be legally sold.

5. Defendant XXXX X. XXXXXXXX was, at all times relevant to this Indictment, a principal in the Everfriendly Veterinary Clinic located at 222 E. 33rd Street, Lincoln, Iowa. [NOTE: names and places changed from original.]
                          The Conspiracy
8. From in or about December 1987 until in or about September 1988, the exact dates being unknown to the Grand Jury, within the Northern District of Iowa and elsewhere, defendant XXXX X. XXXXXXXX did unlawfully, knowingly and willfully combine, conspire, confederate, and agree with persons known and unknown to the Grand Jury, to commit offenses against the United States; that is, to violate the Federal Food, Drug, and Cosmetic Act, Title 21, United States Code, Sections 331 and 333.

9. It was a part of the purpose and object of this conspiracy that the defendant and his coconspirators, with the intent to defraud and mislead, agreed to and did -- contrary to Title 21, United States Code, Section 331(a), (c) & (k) -- receive, manufacture, package, hold for sale, distribute, and introduce and cause to be introduced into interstate commerce animal drug products that were adulterated within the meaning of Title 21, United States Code, Section 351(a)(2)(B) and (a)(5) in that they were new animal drugs which were unsafe within the meaning of Title 21, United States Code, Section 360b, because they lacked approval from FDA.

10. It was a further part of the purpose and object of the conspiracy that the defendant and his coconspirators, with the intent to defraud and mislead, agreed to and did -- contrary to Title 21, United States Code, Section 331(a), (c) & (k) -- receive, manufacture, package, hold for sale, distribute, and introduce and cause to be introduced into interstate commerce animal drug products that were misbranded within the meaning of Title 21, United States Code, Section 352(a), (b)(1), and (f)(1), in that their labeling:
          (a) was false and misleading;

(b) lacked the name and place of business of the manufacturer, packer or distributor; and,

(c) lacked adequate directions for use.

11. In furtherance of the conspiracy and to effect the objects and purposes thereof, the defendant and his coconspirators committed the following overt acts, among others, within the Northern District of Iowa, and elsewhere:
                 (1) On or about December 31, 1987, defendant XXXX
X. XXXXXXXX
issued
                 a check to XYZ Veterinary Clinic of Algona, Iowa,
as payment for
animal
                 drugs.

(2)On or about June 21, 1988, defendant XXXX X. XXXXXXXX caused a package containing animal drugs to be shipped to Everfriendly Veterinary Clinic.

(3) On or about July 5, 1988, defendant XXXX X. XXXXXXXX caused a package containing animal drugs to be shipped to Everfriendly Veterinary Clinic.

(4) On or about August 12, 1988, defendant XXXX X. XXXXXXXX prepared a billing statement reflecting that he had treated a client's animals with "Spec" when in fact he had used the drug chloramphenicol to treat those animals.

All in violation of Title 18, United States Code, Section 371.

COUNT 2 (Misbranded Drug)

1. Paragraphs 1 through 5 of Count 1 are hereby realleged and incorporated by reference as if set forth in full herein.

2. On or about December 7, 1987, within the Northern District of Iowa and elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to defraud and mislead, receive in interstate commerce and proffer the delivery for pay of a quantity of the animal drug chloramphenicol which drug was misbranded, within the meaning of Title 21, United States Code, Section 352(a) and (f)(l), in that the labeling was false and misleading because, among other reasons, it did not indicate that the drug was chloramphenicol, and in that the labeling did not bear adequate directions for use because, among other reasons, it failed to state that chloramphenicol should not be administered to food-producing animals.

All in violation of Title 21, United States Code, Sections 331(c) and 333(b).
                  COUNT 3  (Misbranded Drug)
1. Paragraphs 1 through 5 of Count 1 are hereby realleged and incorporated by reference as if set forth in full herein.

2. On or about June 21, 1988, within the Northern District of Iowa and elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to defraud and mislead, receive in interstate commerce and proffer the delivery for pay of a quantity of the animal drug chloramphenicol which drug was misbranded, within the meaning of Title 21, United States Code, Section 352(a) and (f)(l), in that the labeling was false and misleading because, among other reasons, it did not indicate that the drug was chloramphenicol, and in that the labeling did not bear adequate directions for use because, among other reasons, it failed to state that chloramphenicol should not be administered to food-producing animals.

All in violation of Title 21, United States Code, Sections 331(c) and 333(b).
                   COUNT 4  (Misbranded Drug)
1. Paragraphs 1 through 5 of Count 1 are hereby realleged and incorporated by reference as if set forth in full herein.

2. On or about August 12, 1988, within the Northern District of Iowa and elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to defraud and mislead, receive in interstate commerce and proffer the delivery for pay of a quantity of the animal drug chloramphenicol which drug was misbranded, within the meaning of Title 21, United States Code, Section 352(a) and (f)(l), in that the labeling was false and misleading because, among other reasons, it did not indicate that the drug was chloramphenicol, and in that the labeling did not bear adequate directions for use because, among other reasons, it failed to state that chloramphenicol should not be administered to food-producing animals.

All in violation of Title 21, United States Code, Sections 331(c) and 333(a)(2).

A TRUE BILL

Foreperson

CHARLES W. LARSON
United States Attorney

HENRY I. LaHAIE
Attorney
United States Department of Justice

[cited in USAM 4-8.255]