CHAPTER § 2.07 Practical Considerations

• Jurisdiction: United States

§ 2.07 Practical Considerations

Pharmaceutical firms intending to handle or broker transactions involving controlled substances or listed chemicals must plan carefully for compliance across a range of business functions.

On a day-to-day basis, the need for control systems, employee screening and training, internal powers of attorney, customer credentialing, and other compliance activities add a layer of management obligation and expense. Regulatory-compliance programs should incorporate controlled-substance and listed-chemical concepts (both threshold assessments to determine whether specific requirements apply, and then in-depth review if applicable).

Registration, quota, and sourcing rules circumscribe opportunities or, at least potentially, timelines for new product offerings, supply-chain development, and corporate partnering (e.g., selection of contract manufacturers or other third-party vendors). Applicable laws affect business transactions (e.g., company mergers or acquisitions) to the extent that registration and other regulatory transfers must be approved and implemented.

Finally, firms must remain vigilant, and respond proactively and thoughtfully, to both actual and perceived product-diversion concerns. DEA has quoted a Substance Abuse and Mental Health Services Administration finding that...