United States v. An Article of Drug … Bacto-Unidisk
United States Supreme Court
394 U.S. 784 (1969)
- Written by Alex Ruskell, JD
Facts
The secretary of health, education, and welfare determined that a laboratory aid known as an antibiotic sensitivity disc, which was used as a screening test in determining the proper antibiotic for a patient, was a drug. As a drug, it was subject to premarket clearance regulations. If the aid was a device, it was only subject to the misbranding and adulteration proscriptions of the Federal Food, Drug, and Cosmetic Act and did not need to be pretested before marketing. After the aid was declared a drug, the United States (plaintiff) sued to condemn the discs (defendant). The district court ruled that the aids were devices not subject to pretesting. After the United States Court of Appeals for the Sixth Circuit affirmed, the United States appealed to the United States Supreme Court.
Rule of Law
Issue
Holding and Reasoning (Warren, C.J.)
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