Controlled Substances and DEA

Representative experience

Advise on the interplay between FDA and DEA during the drug development process and through FDA approval and scheduling under the CSA.

Advise an OTC products distributor to assure compliance with the Comprehensive Methamphetamine Control Act.

Analyze the impact of all 50 states' controlled substances laws on launching a newly approved and scheduled new chemical entity.

Help develop SOPs to comply with security, registration, and recordkeeping requirements, and reporting and disposal obligations.

Advise manufacturers on quota issues, including increases in quota allotment to avoid drug shortages.

Help manufacturers with state and federal registration and licensing requirements during transactions to assure a seamless transfer with no business activity interruption.

Advise on the export restrictions taking into account U.S., EU, and international treaty law, so that a global pharmaceutical company could export controlled substances from the U.S. to the EU.

Advise health care providers and pharmaceutical companies on the requirements governing narcotics use for addiction treatment.

Assist clients with DEA applications to obtain exemptions for chemical preparations and mixtures.