Wholesaler Controlled Substance Monitoring Program (CSMP) Audit Process

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Full Article: 

Wholesaler Controlled Substance Monitoring Program (CSMP) audits monitor the distribution of controlled substances to pharmacies, ensuring compliance with due diligence requirements established under injunctive relief settlements. These audits can be triggered for several reasons, including onboarding a new pharmacy, requesting a purchasing threshold increase, addressing red flags of diversion, or conducting random due diligence reviews. 

Audit Process Overview: 

There may be variations to these steps as each wholesaler has a slightly different process. This information is presented to provide a general concept of what to expect during a CSMP audit.  

1. Initial Notification:  
   • Wholesaler sends an email outlining the audit requirement.  
   • Pharmacy Questionnaire (site visit survey) link included, typically with a 3–5 day completion window.  
   • Reminder emails sent if the questionnaire is not completed. Non-response may disrupt controlled substance ordering.  
2. Pharmacy Questionnaire:  
   • Collects pharmacy and personnel information including:  
     • Legal name, address, DEA number, state licenses  
     • Ownership structure and prior regulatory inspections  
     • Pharmacy services and controlled substance dispensing history  
     • Controlled substances security and due diligence procedures  
   • Any disciplinary actions (fraud, diversion, penalties) must be disclosed and may be discussed during PIC interviews.  
3. Pharmacy Customer Data (PCD):  
   • Requested after the questionnaire is approved, sometimes combined in the initial email.  
   • Covers the prior 3 months of dispensing data, including:  
     • Total prescriptions and dosage units (controlled and noncontrolled)  
     • Top prescribers of highly diverted controlled substances  
     • Payment methods, especially cash transactions  
     • Patient zip codes for controlled substance prescriptions  
   • Must be submitted in the requested format to avoid delays.  
4. PCD Analysis:  
   • Wholesaler reviews the submitted data (typically 5–7 days).  
   • Generates reports for discussion during the on-site or virtual visit.  
   • Data is used to identify potential red flags such as:  
     • High controlled-to-noncontrolled ratios  
     • Excessive ordering growth or repeated threshold hits  
     • Out-of-area prescribers or patients  
     • Unusual formulation ordering  
     • Cash prescription patterns  
     • Regulatory actions or customer termination data  
5. On-Site or Virtual Visit:  
   • Scheduled after PCD analysis.  
   • Purpose: review reports, discuss red flags, and evaluate controlled substances due diligence procedures.  
   • Typically involves the PIC and/or pharmacy owners.  
   • Duration: 15–45 minutes depending on the wholesaler and PCD.  

Key Considerations and Expectations: 

• Respond promptly and professionally to all CSMP audit communications.  
• Ensure complete, accurate, and timely submission of Pharmacy Questionnaire and PCD.  
• Be prepared to disclose and discuss prior disciplinary actions if applicable.  
• Maintain awareness of controlled substance dispensing trends, particularly highly diverted substances.  
• Noncompliance can result in suspension or revocation of controlled substance ordering privileges, often for one year.  

Conclusion: 

CSMP audits are critical for regulatory compliance and uninterrupted pharmacy operations. Proper preparation, timely submissions, and adherence to due diligence protocols help pharmacies mitigate risks, maintain wholesaler relationships, and ensure patient care continuity. 

Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice. 

Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy. 

Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates.