## Facts

- Methadone was FDA-approved as safe and effective for severe pain and antitussive purposes.
- Methadone later became widely used in heroin addiction maintenance and detoxification, accompanied by evidence of diversion and abuse.
- FDA had permitted methadone’s addiction-treatment use under an investigational new drug framework.
- In 1972, FDA ended methadone’s investigational status for addiction treatment and adopted a regulatory scheme limiting methadone distribution to specified outlets and provider classes.
- The rule effectively barred most community pharmacies from dispensing methadone even when prescribed by a physician, while allowing certain institutional settings (including approved hospital pharmacies) to dispense methadone for analgesic and antitussive uses.
- The American Pharmaceutical Association and individual health professionals sued federal officials seeking judicial review and invalidation of the FDA regulation on statutory and constitutional grounds.

## Issues

1. Whether the FDCA authorizes FDA to restrict the channels of distribution of an approved prescription drug by limiting dispensing to specified outlets and provider classes.
2. Whether FDA may impose distribution-channel limits even after the agency has determined a drug is safe and effective for approved indications.
3. Whether the Controlled Substances Act displaces or limits FDA’s authority to regulate distribution controls for a controlled substance.

## Decision

- The court upheld the regulation and denied the relief sought by plaintiffs.
- The court held that FDA had statutory authority, under the combined operation of the FDCA and the Controlled Substances Act, to restrict methadone’s distribution channels.
- The court rejected the contention that FDA’s power ends once a drug is approved as safe and effective.
- The court concluded that the controlled-substances regime did not preempt FDA’s drug-safety authority to impose distribution restrictions aimed at preventing diversion and abuse.

## Legal Principles

- FDA’s authority under the FDCA extends beyond initial approval decisions and may include post-approval conditions and controls reasonably related to safe use of a drug.
- Channeling distribution of an approved drug to specified outlets can be a permissible regulatory tool when directed at documented risks of misuse or diversion and when it preserves lawful medical uses under regulated conditions.
- The FDCA and the Controlled Substances Act may operate as complementary federal regimes; regulation under one statute does not necessarily exclude overlapping controls under the other.

## Conclusion

The court sustained FDA’s methadone distribution rule, holding that FDA could lawfully restrict dispensing to specified outlets as a safety-related measure and that the Controlled Substances Act did not foreclose FDA’s concurrent authority to impose such distribution-channel controls.


Am. Pharm. Ass’n v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974)