Panoramic: Automotive and Mobility 2025
Controlled Substances and DEA
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Manufacturers, distributors, researchers, and pharmacies rely on our substantial experience with controlled substances regulation at the state and federal levels. We are particularly familiar with how federal and state agencies implement the complex requirements applicable to controlled substances, as well as products that are not scheduled, but have abuse potential.
We will counsel you on state and DEA regulatory compliance in a variety of circumstances, including suspicious order monitoring and reporting, scheduling, registration, recordkeeping, importation and exportation, security, theft and loss reporting, and drug disposal. We can also conduct compliance reviews of your standard operating procedures and employee training materials to assist in developing and enhancing your internal compliance procedures. And should it be necessary, we will work with you in the event of a state or federal investigation or administrative action.
Additionally, we frequently assist manufacturers with scheduling issues, whether for a new pharmaceutical product or a change in the scheduling status of an already marketed product. Combined with our extensive FDA background, our deep understanding of state and federal controlled substances laws gives us a uniquely informed perspective on, and integrated approach to, the range of regulatory issues you face in developing, marketing, and distributing controlled substances.
Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
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.
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