Inspection Preparation

The U.S. Department of Justice Drug Enforcement Administration (DEA) makes periodic unannounced inspections to audit registered controlled substance storage locations and laboratories.

In a typical audit, DEA Diversion Investigators ensure that the controlled substance licensee/registrant is compliant with the Controlled Substance Act and, if applicable, bring them into compliance by verifying:

• Security practices: authorized personnel, controlled substance storage
• Record keeping practices: DEA Form 222's (if applicable), invoices, complete and accurate inventories, use, disposal, and waste logs. Particular attention will be paid to documented discrepancies.

The DEA is a law enforcement agency, with the ability to assess civil and criminal penalties. Non-compliance violations can result in increasing levels of penalty, including:

• Letter of Admonition
• $10,000 fine to the licensee/registrant for each violation
• Suspension or revocation of a controlled substance practitioner and/or research registration
• Prison sentence

Preparation

Always be prepared! DEA inspections may occur late in the day or near holiday weekends. The licensee/registrant and all authorized personnel must be knowledgeable about federal and state regulations, Roswell Park policies, as well as laboratory policies and procedures regarding security, ordering, storage, and administration of controlled substances in research. This includes record keeping requirements and an action plan to immediately retrieve records for a DEA inspection.

See the Policies page for links to the Federal, State, and Roswell Park controlled substance policies.

Refer to the Controlled Substances Inspection Guidelines in the event of a DEA or NYS BNE inspection.

Inspection procedure

Upon arrival of a DEA Diversion Investigator:

1. Review their credentials, photo identification, and obtain their contact information
2. Inquire about the reason for the inspection
3. Immediately notify the following of the reason for the inspection
   • The licensee/registrant
   • Amy Kirkpatrick , 716-845-4559
4. Reserve a conference room for the investigators use
5. Sign the Notice of Inspection (DEA Form 82), which acts as informed consent (licensee/registrant only)
6. Upon request, provide access to the controlled substance storage cabinet or safe (licensee/registrant or authorized agent only)
7. Upon request, be prepared to provide any of the following (any authorized personnel):
   • NYS controlled substance license and DEA Certificate of Registration (Form 223)
   • Authorized personnel log, with screening statements
   • Laboratory policies and procedures regarding security, ordering, storage, and administration of controlled substances
   • Most recent inventory (e.g., initial, biennial)
   • Current general and usage logs
   • Disposal records
   • Access to controlled substance storage cabinet or safe
   • Purchasing records (i.e., invoices, packing slips, DEA Form 222s), with Schedule I – II records separated from Schedule III – V.
   • Breakage-spillage reports, if applicable (DEA Form 41)
   • Theft/significant loss reports, if applicable (DEA Form 106)

During the inspection

• The DEA investigators may audit select controlled substances to track usage from the last biennial inventory or purchase invoice. This includes asking the licensee/registrant or authorized agents to physically count, weigh, or otherwise inventory the substance.
• Copy any records required by the DEA and obtain a receipt (DEA Form 12) for any original records and/or controlled substances taken off-site.
• Take notes of all recommendations and observations made by the DEA Investigators.
• Ask any questions you might have regarding the DEA findings so corrective actions can be implemented.
• Answer the DEA investigator’s questions as concisely as possible. Always be truthful; don't speculate. If you do not know the answer to a question, be thoughtful and helpful in your answer, explaining, “I don’t have the answer offhand, but I know where to find it,” or “Please let me find the person with the answer.” Ask for clarification if you do not understand a question.
• Be polite and cordial. Do not argue or debate with the DEA investigator.

Questions?

Jillianna Wasiura
Director, Diversion Prevention
Phone: 716-845-3425
Email: Jillianna.Wasiura@RoswellPark.org

Ericka Bennett
Vice President for Corporate Ethics, Research Integrity & Research Subject Protection
Phone: 716-845-8132
Email: Ericka.Bennett@roswellpark.org