Compliance with controlled substances regulations is one of the most highly regulated areas in the U.S. pharmaceutical industry. Companies dealing with narcotics, psychotropics, or precursor chemicals must comply with both the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). Overlapping requirements make compliance complex, requiring detailed knowledge of scheduling, security, and reporting obligations.

Controlled substances scheduling is established under the Controlled Substances Act (CSA). Drugs are classified into five schedules (I–V) based on their medical use, abuse potential, and safety profile. Sponsors, manufacturers, distributors, and researchers must understand the classification of their products to determine the applicable restrictions and authorization requirements.

Key compliance elements include:

• Scheduling Guidance – Determining whether a substance is listed under Schedule I–V and ensuring correct handling protocols.
• DEA Registration – Mandatory for facilities involved in manufacturing, distribution, research, import, or export of controlled substances.
• FDA Compliance – Labeling, clinical trial oversight, and product approval processes for drugs that also fall under FDA jurisdiction.
• Import/Export Authorization – DEA Form 357 (import) and DEA Form 236 (export) submissions, along with FDA prior notice requirements.
• Security & Recordkeeping – Maintaining stringent controls to prevent diversion, including inventory logs, restricted access, and reporting.
• Reporting Obligations – ARCOS (Automation of Reports and Consolidated Orders System) filings, theft/loss notifications, and adverse event reports.

At XPRO America, we support clients in navigating this complex DEA–FDA compliance overlap by offering:

• Controlled Substance Scheduling Reviews to assess product classification.
• DEA & FDA Registration Assistance for manufacturing, research, and distribution facilities.
• Import/Export Authorization Support to streamline cross-border movement of scheduled substances.
• Inspection & Audit Preparation for both DEA and FDA regulatory inspections.
• Ongoing Compliance Monitoring to ensure adherence to evolving regulatory updates.

With our expertise, companies can avoid enforcement risks, delays, and penalties while maintaining uninterrupted business operations. Our tailored solutions provide the assurance that your controlled substance operations are fully compliant with both DEA and FDA regulations.

XPRO America helps with DEA & FDA controlled substances compliance, scheduling guidance, registration, and import/export authorization support.