BENTEX PHARMACEUTICALS, INC., et al., Appellants,
v.
Elliot P. RICHARDSON, Secretary of the Department of Health, Education and Welfare and Charles C. Edwards, Commissioner of the Food and Drug Administration, Appellees.
United States Court of Appeals, Fourth Circuit.https://leagle.com/images/logo.png
Argued December 8, 1971.
Decided May 23, 1972.
Attorney(s) appearing for the Case
George F. Townes, Greenville, S. C. (Sol E. Abrams, Greenville, S. C., on brief), for appellants.
Charles R. McConachie, Atty., Dept. of Justice (Will Wilson, Asst. Atty. Gen., John L. Murphy, Chief, Administrative Regulations Section, William W. Goodrich, Asst. Gen. Counsel, Food, Drugs, and Environmental Health Div., Robert N. Anderson, Atty., U. S. Dept. of Health, Education and Welfare, and Howard S. Epstein, Atty., Dept. of Justice, on brief), for appellees.
Before WINTER, RUSSELL and FIELD, Circuit Judges.
United States Court of Appeals, Fourth Circuit.
RUSSELL, Circuit Judge:
This appeal turns on a construction of the Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962.1 21 U.S.C. § 301 et seq. This statute requires premarketing approval and clearance of any "new drug" by the Secretary of Health, Education and Welfare.2 The term "new drug" is defined as one "not generally recognized, among experts qualified by scientific training...
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