## Facts

- Maine amended its pharmacy statute in 2013 to permit Maine residents to obtain prescription drugs by mail or carrier from certain foreign pharmacies without those entities being licensed as Maine pharmacies.
- The amendments covered pharmacies located in Canada, the United Kingdom, Australia, or New Zealand, and certain contracting entities in those countries, allowing dispensing and shipment to Maine residents for personal use.
- Two Maine pharmacists and several pharmacist trade organizations sued Maine’s Attorney General and the Commissioner of Administrative & Financial Services in their official capacities, seeking declaratory and injunctive relief.
- Plaintiffs alleged the amendments conflicted with the federal Food, Drug, and Cosmetic Act (FDCA), which comprehensively regulates prescription-drug approval, labeling, and importation into U.S. commerce.
- The State argued the amendments concerned only state licensure and registration, an area traditionally regulated by states, and did not authorize violations of federal law.
- The court treated plaintiffs’ summary-judgment motion as a Rule 12(c) motion for judgment on the pleadings, resolving the facial preemption question without discovery.

## Issues

1. Whether the challenged provisions of Maine’s 2013 pharmacy-law amendments were facially preempted by the FDCA under the Supremacy Clause.
2. Whether the amendments created a conflict by standing as an obstacle to Congress’s objectives in the FDCA’s prescription-drug approval and importation scheme.
3. Whether characterizing the statute as a pharmacy-licensing measure avoided preemption where the statute’s legal operation facilitated importation of foreign prescription drugs to Maine residents.

## Decision

- The court granted plaintiffs’ motion for judgment on the pleadings and denied the State’s competing motion.
- The court declared the challenged provisions invalid under the Supremacy Clause because they were preempted by the FDCA.
- The court held the conflict was facial and could be determined from the statutes’ text and operation, without factual development through discovery.

## Legal Principles

- State law is preempted when it conflicts with federal law or when it stands as an obstacle to the accomplishment and execution of Congress’s purposes and objectives.
- The FDCA establishes a comprehensive federal scheme regulating the distribution of prescription drugs in interstate commerce, including strict controls on importation, approval status, and labeling.
- A state statute framed as regulating a traditional state domain (such as pharmacy licensure) may still be preempted if its practical and legal effect authorizes or facilitates conduct inconsistent with federal regulatory objectives.
- Facial preemption may be found where the structure and operation of a statute creates a categorical obstacle to federal policy, regardless of how the statute is implemented in particular cases.

## Conclusion

The court held that Maine’s statutory pathway for Maine residents to obtain prescription drugs by mail from specified foreign pharmacies, exempting those entities from Maine pharmacy licensure, facially interfered with the FDCA’s federally controlled prescription-drug importation and safety regime and was therefore preempted under the Supremacy Clause.


Ouellette v. Mills, 91 F. Supp. 3d 1 (D. Me. 2015)