Controlled Substances – Regulation, Litigation, and Enforcement

Meet the fictional company, review the initial government contact, and establish response teams that will work together throughout the day.

• Reviewing the fictional company, business operations, and facts surrounding the initial government inquiry
• Identifying key stakeholders and assigning responsibilities across legal, compliance, regulatory, quality, operations, and executive leadership
• Establishing response objectives, communication protocols, and decision-making priorities for the first 72 hours

LAB Output: Response Team Role Map

Determine whether the organization is facing an inspection, records request, subpoena, civil investigative demand, search warrant, or broader enforcement matter, and determine the immediate response priorities that will shape the first 72 hours.

• Distinguishing between inspections, subpoenas, civil investigative demands, records requests, search warrants, and other enforcement actions
• Determining immediate response obligations, notification requirements, and escalation procedures
• Avoiding common mistakes that can increase regulatory exposure during the first hours of government engagement

LAB Output: Government Contact Decision Tree & First-Response Checklist

Establish authority, decision-making responsibilities, and escalation protocols across legal, compliance, quality, regulatory, investigations, and operations teams.

• Establishing clear authority and accountability across cross-functional response teams
• Defining decision-making, reporting, and escalation pathways during fast-moving investigations
• Coordinating internal and external communications while preserving consistency and privilege

LAB Output: Response Command Structure & Responsibility Matrix

Manage regulator interactions, preserve evidence and privilege, and control document and information requests as scrutiny intensifies.

• Managing regulator access to facilities, personnel, records, systems, and controlled information
• Preparing employees for interviews while protecting legal rights and preserving privilege
• Implementing document preservation, data collection, and evidence-management protocols

LAB Output: Regulator Access, Interview & Preservation Protocol

Compare response structures, identify operational gaps, and assess whether existing procedures will withstand real-world regulatory scrutiny.

• Assessing whether existing response plans and governance structures will perform under real-world scrutiny
• Identifying gaps between written procedures and actual organizational capabilities
• Benchmarking response practices against peer organizations and regulatory expectations

LAB Output: Response Readiness Gap Assessment

A second agency or authority enters the matter. Navigate parallel investigations, overlapping requests, and multiple regulatory workstreams without creating conflicting positions.

• Managing simultaneous inquiries from multiple agencies without creating conflicting positions
• Coordinating legal, regulatory, and investigative workstreams across jurisdictions
• Maintaining consistent communications, documentation, and response strategies throughout the investigation

LAB Output: Multi-Agency Coordination Map & Communications Log

Balance regulatory obligations with manufacturing, distribution, pharmacy, healthcare, and patient-access responsibilities as scrutiny intensifies.

• Balancing regulatory obligations with manufacturing, distribution, pharmacy, healthcare delivery, and patient access priorities
• Evaluating operational, reputational, and business-continuity risks during an active investigation
• Making difficult decisions regarding product movement, operations, staffing, and customer communications

LAB Output: Business Continuity & Operational Risk Decision Framework

Prepare executive and board-level updates, prioritize corrective actions, and avoid common mistakes that can increase risk during an active investigation.

• Preparing executive leadership and board-level briefings during an evolving enforcement matter
• Prioritizing corrective actions and remediation efforts while facts are still being developed
• Avoiding admissions, communications, or remediation decisions that may increase future liability

LAB Output: Executive Reporting Template & Remediation Decision Matrix

Respond to a final escalation, such as a media inquiry, whistleblower allegation, or expansion of government scrutiny, while integrating the tools developed throughout the day.

• Responding to escalation events including media inquiries, whistleblower allegations, parallel investigations, and expanded search activity
• Testing response plans against evolving facts and unexpected developments
• Finalizing a practical 72-hour response framework that can be adapted for future FDA, DEA, DOJ, and state enforcement actions

LAB Output: Completed First 72-Hour Enforcement Response Manual

By the end of the LAB, participants will have developed a practical framework for managing the first 72 hours of a government inquiry and strengthening their organization’s readiness for future FDA, DEA, DOJ, and state enforcement activity.

As regulatory expectations continue to evolve across the pharmaceutical and healthcare sectors, organizations must stay ahead of FDA priorities impacting controlled substances, drug security, supply chain integrity, emerging therapies, and compliance oversight. This address will provide insight into FDA’s current areas of focus and the issues shaping the agency’s regulatory and compliance agenda for 2027.

As regulatory expectations evolve and concerns around drug shortages persist, companies must navigate how quota decisions impact production planning, inventory management, patient access, and compliance obligations. This session will examine recent developments in quota administration, explore operational implications for registrants, and provide practical strategies for navigating an increasingly complex quota environment.

Discussion points include:

• Navigating DEA’s evolving approach to quota administration and the implications for manufacturers, importers, and supply chain planning
• Assessing how quota decisions influence production, procurement, inventory management, and patient access to critical medications
• Examining industry concerns related to transparency, predictability, communication, and timing within the quota process
• Developing strategies to manage compliance obligations, mitigate supply disruptions, and prepare for future quota-related changes

DEA administrative proceedings can present significant challenges for registrants seeking to understand the evidence against them and mount an effective defense. While the Controlled Substances Act, DEA regulations, and the Administrative Procedure Act provide various discovery mechanisms and procedural protections, practitioners often face substantial limitations in obtaining information critical to their case.

This session will examine how discovery operates in DEA administrative proceedings, the practical realities registrants face when responding to Orders to Show Cause, and strategies for building an effective defense before the Agency and on appeal.

As demand for compounded therapies continues to grow, organizations face increasing questions around patient access, FDA oversight, quality standards, and regulatory compliance. From compounded GLP-1 products to emerging therapies, stakeholders must navigate a rapidly evolving landscape where business opportunities, public health considerations, and enforcement risks increasingly intersect. This session will explore the key regulatory developments, compliance expectations, and operational challenges shaping the future of compounding.

• Assessing how the growth of compounded GLP-1s and other high-demand therapies is reshaping the regulatory and enforcement landscape
• Examining FDA expectations, quality standards, and compliance obligations for compounders, outsourcing facilities, manufacturers, and healthcare providers
• Evaluating the balance between patient access, drug shortages, affordability concerns, and regulatory oversight
• Preparing for emerging enforcement risks, investigations, and compliance challenges as compounding continues to expand across the healthcare marketplace

With DEA expected to finalize its long-awaited Special Registration framework, healthcare providers, telemedicine platforms, pharmacies, and compliance professionals must prepare for the next phase of controlled substance prescribing. This session examines evolving federal and state requirements and provides practical guidance for navigating remote prescribing while balancing compliance, diversion prevention, and patient access.

Discussion points include:

• Assessing the implications of DEA’s anticipated Special Registration framework and how organizations should prepare for new prescribing, documentation, and compliance requirements
• Navigating the growing complexity of federal and state telemedicine requirements, including practitioner licensure, patient-provider relationship standards, and prescription validity expectations
• Managing compliance and enforcement risks associated with remote prescribing, including corresponding responsibility, pharmacy verification obligations, and heightened scrutiny of controlled substance prescriptions
• Balancing patient access, operational efficiency, and diversion prevention as telemedicine providers, pharmacies, and healthcare organizations prepare for the next phase of DEA oversight

The proposed rescheduling of marijuana has the potential to fundamentally reshape the regulatory landscape for controlled substances. As organizations evaluate the possible transition from Schedule I to Schedule III, questions remain surrounding registration requirements, compliance obligations, enforcement priorities, research opportunities, and the future of state and federal oversight. This session will examine the latest developments, explore the practical implications for industry participants, and help organizations prepare for a rapidly evolving regulatory environment.

Discussion points include:

• Assessing the compliance, operational, and business implications of moving marijuana from Schedule I to Schedule III
• Understanding how DEA registration, manufacturing, distribution, prescribing, and research requirements may evolve under a new regulatory framework
• Examining the interaction between federal rescheduling efforts and existing state medical and adult-use cannabis programs
• Preparing for emerging enforcement, litigation, and compliance risks as regulators, healthcare providers, manufacturers, and distributors adapt to a changing cannabis landscape

The 2026 Executive Order signaled a major shift in the federal government’s approach to psychedelic research, development, and therapeutic access. As FDA, DEA, HHS, VA, and other stakeholders work to implement new policies and regulatory frameworks, organizations must navigate evolving expectations related to clinical development, scheduling, patient access, provider oversight, and commercialization. This session will examine the current state of psychedelic policy, emerging implementation challenges, and the opportunities and risks shaping the future of psychedelic therapeutics.

• Assessing progress since the 2026 Executive Order and examining how federal agencies are implementing psychedelic research, treatment, and access initiatives
• Evaluating the regulatory pathways for psilocybin, ibogaine, and other emerging psychedelic therapies, including clinical development, approval, and scheduling considerations
• Examining implementation challenges involving provider oversight, patient safety, reimbursement, treatment delivery models, and regulatory coordination
• Preparing for the compliance, operational, and commercialization implications of a rapidly evolving psychedelic therapeutic landscape

As expectations surrounding controlled substance prescribing and dispensing continue to evolve, pharmacies, healthcare systems, and telemedicine providers must navigate increasing scrutiny of the valid prescription standard and corresponding responsibility requirements. This session will examine recent enforcement trends, emerging risk areas, and practical strategies for evaluating red flags, documenting decision-making, and reducing liability exposure.

• How regulators are interpreting the valid prescription standard and corresponding responsibility requirements across pharmacies, healthcare systems, and telemedicine providers
• Recent enforcement actions and identify the prescribing, dispensing, and documentation practices that most frequently lead to regulatory scrutiny and liability exposure
• Assessing and responding to common red flags while maintaining appropriate patient access and meeting compliance obligations
• Exploring practical strategies for strengthening dispensing controls, documenting decision-making, and reducing civil, administrative, and criminal enforcement risk