United States v. Article of Drug . . . Bacto-Unidisk

Background

The dispute involved antibiotic sensitivity discs (sold as Bacto-Unidisk by Difco Laboratories) seized by the Government for interstate shipment because they were marketed without pre-market certification. These paper discs are impregnated with antibiotics and used only in laboratory diffusion tests to help doctors choose which antibiotic may work; the discs never touch a patient. The Secretary of Health, Education, and Welfare adopted regulations in 1960 after complaints and a study found unreliable potency in such discs. The District Court and the Court of Appeals held the discs were not "drugs" and that seizure was improper.

Reasoning

The core question was whether the discs fall within the Act’s wording for items "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." The Court examined the statute’s language, legislative history, and remedial purpose. It concluded Congress intended a broad definition of "drug," not limited to narrow medical usage, and that the device exception was meant to exclude only plainly mechanical or quack contraptions. The Court deferred to the agency’s public-health judgment and held the discs are covered as drugs, allowing the Secretary to require pre-market batch testing and certification under the Act, and reversed the lower courts.

Real world impact

As a result, the Food and Drug Administration may require batch testing and pre-clearance of antibiotic sensitivity discs. Manufacturers must comply with certification rules or risk seizures of shipments. The ruling leaves open detailed boundaries of the device exception but affirms broad federal authority to regulate lab aids that affect antibiotic choice.

Dissents or concurrances

Justice Douglas would have affirmed the lower court, viewing the discs as "devices," and disagreed with the majority’s classification of the discs as drugs.