In this episode, Sam welcomes Dennis Wichern, a retired DEA special agent who now runs Prescription Drug Consulting, to discuss various aspects of compliance and regulatory guidance essential for running a ketamine infusion clinic. 

Dennis shares his extensive background in federal law enforcement and provides valuable insights into the DEA's procedures for audits, record keeping, and security. 

The episode also covers the historical context of the DEA, the impact of telehealth on controlled substance regulations, and advice for clinicians on risk mitigation and best practices.

Friendly reminder: this podcast is for educational purposes only. The views expressed in this episode are those of the speaker and do not constitute legal or medical advice. Always consult with a professional before making decisions for your business or medical practice.

What You'll Learn in This Episode:

• Understanding DEA Audits: Learn about what triggers a DEA visit and the focus areas of these audits.

• Record Keeping Essentials: Discuss the critical elements of record keeping and how to avoid common pitfalls.

• Advice for New Clinicians: Practical advice for clinicians new to the field, focusing on compliance and ethical practice.

Episode 23 show notes:

00:00 Teaser - When The DEA Visits You…

00:22 Welcome to the Ketamine Startup Podcast

00:35 Meet Dennis Wichern: DEA Special Agent Turned Consultant

01:45 Dennis Wichern's Career Journey with the DEA

03:13 Transition to Pharmaceutical Control and Consulting

06:27 Understanding the DEA's Role and Regulations

08:08 The Banking Model Metaphor for DEA Regulations

12:29 Key Elements of Record Keeping and Security

15:22 Risk and Penalties for Ketamine Clinics

23:25 Red Flags and DEA Audits

27:14 Free Ketamine Clinic Startup Checklist

27:58 State-Level DEA Enforcement Variations

31:25 Advice for Clinicians on Inventory Management

33:31 Witnessing and Documentation in Small Clinics

35:47 Online Ketamine Therapy and DEA Perspectives

40:51 Political Influence on DEA Regulations

44:20 Starting a Ketamine Clinic: Key Advice

50:40 Rapid Fire Questions and Contact Information

52:53 Closing remarks

Thanks for listening

Connect with Dennis:

LinkedIn

Prescription Drug Consulting Website

Email: dennis.wichern@prescriptiondrugconsulting.com

Phone: (312) 859-2430

Selected links and references:

Ryan Haight Act

This doctor prescribed ketamine from his home. DEA shut it down.

Missoula doctor settles alleged Controlled Substances Act recordkeeping violations for $85,000

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