## Facts

- Positron emission tomography (PET) uses short half-life radiopharmaceuticals prepared near the point of use, often in nuclear pharmacies at hospitals and universities.
- In 1984, FDA issued guidelines stating PET radiopharmaceuticals were not subject to the Federal Food, Drug, and Cosmetic Act (FDCA).
- In 1995, FDA published a “Notice” stating PET radiopharmaceuticals “should be regulated” as drugs under the FDCA and that PET producers would be subject to the approval, manufacturing, and labeling requirements applicable to conventional prescription drugs.
- The 1995 Notice stated it “superseded” the 1984 guidelines and was issued without notice-and-comment rulemaking because FDA treated it as nonbinding guidance (an interpretive rule or policy statement).
- Syncor and related professional organizations challenged the Notice under the Administrative Procedure Act (APA), asserting it was a legislative rule adopted without required procedures.
- The district court granted summary judgment to FDA, concluding the Notice was non-substantive and exempt from notice and comment.

## Issues

1. Whether the FDA’s 1995 PET Notice was an interpretive rule or general statement of policy exempt from APA notice-and-comment requirements.
2. Whether the Notice instead functioned as a substantive (legislative) rule because it changed regulated parties’ legal obligations by bringing PET radiopharmaceuticals under the FDCA.

## Decision

- The D.C. Circuit reversed the district court.
- The court held the 1995 PET Notice was a substantive (legislative) rule, not an interpretive rule or policy statement.
- Because it was substantive, the Notice could not be issued without APA notice-and-comment procedures.
- The court remanded with instructions to vacate the Notice and enter summary judgment for Syncor.

## Legal Principles

- Under APA § 553(b)(3)(A), interpretive rules and general statements of policy are exempt from notice-and-comment requirements, but legislative rules are not.
- A document is not exempt merely because the agency labels it “guidance” or a “policy statement”; courts look to the document’s substance and practical effect.
- An interpretive rule ordinarily reflects an agency’s construction of a statute it administers; a legislative rule modifies or adds to the governing legal norm based on the agency’s delegated authority.
- An agency pronouncement that reverses a prior definitive position and imposes new binding obligations on regulated parties is strong evidence of a legislative rule requiring notice and comment.

## Conclusion

The court concluded that FDA’s 1995 PET Notice effectuated a regulatory change—subjecting PET radiopharmaceuticals to the FDCA after previously stating the opposite—and therefore constituted a legislative rule that had to be promulgated through APA notice-and-comment procedures; the Notice was vacated.


Syncor Int'l Corp. v. Shalala, 127 F.3d 90 (D.C. Cir. 1997)