## Facts

- The United States filed an in rem seizure and condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., against one drum containing about 104,000 tablets labeled “White Quadrisect.”
- The label identified the product as manufactured for Scrip, Inc., and referenced George N. Bell Manufacturing Chemists.
- White Quadrisect was a prescription drug used to treat spasms in the gastrointestinal/biliary tract.
- The government alleged the drug was “adulterated” under 21 U.S.C. § 351(a)(2)(B) because the methods, facilities, or controls used to manufacture the tablets did not conform to “current good manufacturing practice” (GMP).
- After trial, the district court found multiple GMP violations, including:
  - failure to keep basic production records,
  - inadequate testing of active ingredients before use, and
  - insufficient testing of the finished tablets before shipment.
- Based on those findings, the district court ordered condemnation of the seized shipment.
- On appeal, the claimant did not dispute the district court’s GMP-violation findings; instead, it argued that the statutory phrase “current good manufacturing practice” is void for vagueness under the Due Process Clause of the Fifth Amendment.

## Issues

1. Whether 21 U.S.C. § 351(a)(2)(B)’s “current good manufacturing practice” requirement is unconstitutionally vague under the Fifth Amendment’s Due Process Clause.

## Decision

- The Seventh Circuit affirmed the district court’s condemnation judgment.
- Because the GMP findings were not challenged on appeal, the court treated them as established.
- The court rejected the facial vagueness challenge, holding that § 351(a)(2)(B)’s “current good manufacturing practice” standard provides constitutionally sufficient notice, particularly in light of FDA regulations that specify GMP requirements in detail.

## Legal Principles

- A drug is deemed “adulterated” under 21 U.S.C. § 351(a)(2)(B) if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to current GMP designed to help assure safety and the drug’s represented identity, strength, quality, and purity.
- A statute is not void for vagueness if it gives regulated parties fair notice of what is required and supplies standards that limit arbitrary enforcement; exact precision is not required.
- In a technical, heavily regulated industry, Congress may use a general statutory standard and authorize an agency to issue detailed regulations that give the standard concrete content.
- FDA’s GMP regulations can provide the practical detail needed to make the statutory GMP requirement workable and enforceable.

## Conclusion

The Seventh Circuit upheld condemnation of the White Quadrisect shipment as adulterated, holding that the FDCA’s “current good manufacturing practice” requirement in 21 U.S.C. § 351(a)(2)(B) is not unconstitutionally vague and that, given the established recordkeeping and testing failures and the FDA’s detailed GMP regulations, the claimant had adequate notice of the conduct the statute and regulations require.


United States v. An Article of Drug … White Quadrisect, 484 F.2d 748 (1973)