## Facts

- In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) to deem a drug “adulterated” if the methods used in, or the facilities or controls used for, manufacturing, processing, packing, or holding do not conform to “current good manufacturing practice” (CGMP). See 21 U.S.C. § 351(a)(2)(B).
- The FDA issued CGMP regulations after the 1962 amendments and later determined that the existing rules should be revised and updated.
- In February 1976, the FDA published a notice of proposed rulemaking to revise the CGMP regulations and stated the Commissioner’s view that CGMP regulations should be “binding specific requirements” and that failure to comply would render a drug adulterated under § 351(a)(2)(B).
- After notice-and-comment rulemaking, the FDA issued revised CGMP regulations in 1978, codified at 21 C.F.R. Parts 210 and 211, with an effective date in 1979.
- Two trade associations—the National Association of Pharmaceutical Manufacturers and the National Pharmaceutical Alliance—filed suit against the FDA in the Southern District of New York seeking declaratory relief, arguing that the FDCA did not authorize the FDA to issue substantive CGMP regulations with the force of law.
- The district court granted the FDA’s Rule 12(b)(6) motion to dismiss for failure to state a claim, and the associations appealed.

## Issues

1. Whether the FDCA’s general rulemaking provision, 21 U.S.C. § 371(a) (authorizing regulations “for the efficient enforcement” of the Act), permits the FDA to promulgate CGMP regulations as binding requirements with the force of law.
2. Whether CGMP regulations may be treated as enforceable requirements such that noncompliance can be used to show adulteration under 21 U.S.C. § 351(a)(2)(B).

## Decision

- The Second Circuit affirmed the district court’s dismissal of the complaint.
- The court held that FDCA § 371(a), read in context with the Act and the 1962 CGMP adulteration amendment, authorizes the FDA to issue CGMP regulations through notice-and-comment rulemaking that are binding, not merely advisory.
- The court accepted that treating noncompliance with valid CGMP regulations as a basis for adulteration under § 351(a)(2)(B) is consistent with the statute, because Congress itself made failure to meet CGMP a form of adulteration and the regulations specify what CGMP requires.

## Legal Principles

- A general statutory authorization to issue regulations “for the efficient enforcement” of a regulatory statute may permit substantive rules when the statute establishes a standard that requires administrative specification to be workable.
- When Congress sets an open-textured standard (such as “current good manufacturing practice”), an agency may lawfully issue rules that give concrete content to that standard, so long as the rules remain tied to the statute.
- Agency regulations may function as enforceable requirements when they implement a statutory prohibition; doing so does not create a new prohibition separate from the statute.
- Legislative history and the practical needs of enforcement can support reading a broad rulemaking clause to allow public, prospective rules rather than case-by-case determinations in enforcement litigation.
- Binding technical regulations can reduce repeated disputes over what the statutory standard requires and can provide clearer notice to regulated parties and courts.

## Conclusion

In *National Association of Pharmaceutical Manufacturers v. Food and Drug Administration*, the Second Circuit held that the FDCA authorizes the FDA, under § 371(a), to issue binding CGMP regulations through notice-and-comment rulemaking, and that failure to comply with those regulations may be used to establish adulteration under § 351(a)(2)(B); the court therefore affirmed dismissal of the manufacturers’ trade associations’ challenge.


National Association of Pharmaceutical Manufacturers v. Food and Drug Administration, 637 F.2d 877 (1981)