## Facts

- The United States sued Rx Depot, Inc., Rx of Canada, LLC, and two principals to stop an alleged scheme facilitating prescription-drug imports from Canada into the United States.
- Defendants operated U.S. storefronts where customers presented prescriptions, completed paperwork, and paid; store personnel transmitted the information to Canadian pharmacies.
- Canadian pharmacies arranged for a Canadian physician to reissue prescriptions and shipped drugs directly to U.S. customers.
- Defendants profited through commission-based compensation and advertised significant savings on prescription drugs.
- The government presented evidence that drugs obtained through defendants’ process included unapproved drugs, drugs lacking FDA-compliant labeling, and FDA-approved drugs that were exported and reimported by entities other than the original manufacturer.
- The court found defendants did not physically possess or ship the drugs but played an essential role in initiating and processing transactions that resulted in importation into the United States.
- After a two-day evidentiary hearing on cross-motions for preliminary injunction, the court issued findings of fact and conclusions of law.

## Issues

1. Whether defendants “caused” or were responsible for prohibited acts under the FDCA, including importation of unapproved or misbranded drugs (21 U.S.C. §§ 331(a), 331(d)) and unlawful reimportation (21 U.S.C. § 381(d)(1), enforced through § 331(t)).
2. Whether the United States satisfied the requirements for a preliminary injunction under 21 U.S.C. § 332 to restrain ongoing FDCA violations.
3. Whether defendants were entitled to a preliminary injunction barring the government from enforcing the FDCA against their business model.

## Decision

- The court granted the United States’ motion for a preliminary injunction.
- The court found a strong likelihood that defendants’ activities violated the FDCA by causing the importation and reimportation of prescription drugs outside the FDA regulatory system.
- The court concluded the public-health risks and statutory purpose of the FDCA supported injunctive relief, and that economic harm to defendants did not outweigh enforcement interests.
- The court denied defendants’ motion to enjoin FDCA enforcement, rejecting policy-based arguments as matters for Congress rather than judicial exemption.

## Legal Principles

- Introducing or delivering for introduction into interstate commerce an unapproved new drug or a misbranded drug is a prohibited act under the FDCA. 21 U.S.C. §§ 331(a), 331(d).
- Reimportation of an FDA-approved drug by a person other than the original manufacturer violates 21 U.S.C. § 381(d)(1) and constitutes a prohibited act under 21 U.S.C. § 331(t).
- FDCA liability can extend to parties who do not possess or ship drugs but who cause or facilitate prohibited importation through organizing, processing, and profiting from the transactions.
- Under 21 U.S.C. § 332, the United States may obtain injunctive relief to restrain ongoing violations of 21 U.S.C. § 331, particularly where the conduct threatens public health and cannot be adequately addressed by damages.
- Courts will not create equitable exceptions to explicit FDCA prohibitions based on consumer-cost or enforcement-policy arguments.

## Conclusion

The court preliminarily enjoined Rx Depot-related entities and principals from continuing a storefront-based system that facilitated Canadian prescription-drug shipments into the United States, holding the government showed a strong likelihood of FDCA violations and that public-health and statutory-enforcement interests warranted immediate injunctive relief.


United States v. Rx Depot, Inc., 290 F. Supp. 2d 1238 (N.D. Okla. 2003)