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GRAND LABORATORIES, INC. v. HARRIS

No. 80-1331.

644 F.2d 729 (1981)

GRAND LABORATORIES, INC., Appellee, v. Patricia HARRIS, Secretary of Health, Education and Welfare, Appellant.

United States Court of Appeals, Eighth Circuit.

Decided March 25, 1981.

Rehearing and Rehearing Granted May 29, 1981.

Attorney(s) appearing for the Case

Sanford M. Litvack, Asst. Atty. Gen., John J. Powers, III, Peter L. De La Cruz, Attys., Dept. of Justice, Washington, D. C., for appellant; John J. Ulrich, Asst. U. S. Atty., Sioux Falls, S. D., of counsel.

Nancy L. Buc, Chief Counsel, Fredrick H. Degnan, Asst. Chief Counsel, for Veterinary Medicine Food and Drug Administration, Rockville, Md.

George T. Qualley, Qualley, Larson & Jones, Sioux Falls, S. D., Philip C. Jones, Harold M. Carter, Alan W. Brick, Qualley, Larson & Jones, Washington, D. C., for appellee.

Before HEANEY, Circuit Judge, GIBSON, Senior Circuit Judge, and ARNOLD, Circuit Judge.

Rehearing and Rehearing En Banc Granted May 29, 1981.

FLOYD R. GIBSON, Senior Circuit Judge.

This case presents the question whether animal biologics constitute drugs within the meaning of the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 321(g)(1) (1976).

I.

In February 1979, two field officers from the Food and Drug Administration (FDA) attempted to inspect the facilities of Grand Laboratories, Inc. (Grand) in Freeman, South...

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