Area of focus

Controlled Substances and DEA

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 ...

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.

Press Releases

Hogan Lovells obtains acquittals of all felony charges for former New York State Assemblyman

New York, 29 July 2019 – Global law firm Hogan Lovells represented former New York State Assemblyman Alec Brook-Krasny in a case brought by the Office of the Special Narcotics...

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Blog Post

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

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Blog Post

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

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Hogan Lovells Publications

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders Pharmaceutical and Biotechnology Alert

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that...

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Hogan Lovells Publications

U.S. House legislation highlights escalating government-wide focus on opioid abuse Pharmaceutical and Biotechnology Alert

On June 22 the U.S. House of Representatives passed sweeping legislation that represents "the biggest effort Congress has ever undertaken" to address the opioid epidemic, according to Rep....

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Current issues in the distribution of controlled substances

Join us for a complimentary webinar on current issues affecting the distribution of controlled substances. In an efficient hour, we will provide an overview of the current state of play in...

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