Injunctive Relief & Wholesaler CSMP Audits — Quick Guide

RELATED LINKS 

For additional resources to support wholesaler CSMP compliance click HERE. 

FULL ARTICLE: 

What is Injunctive Relief? 

• National settlement with major wholesalers (AmerisourceBergen, Cardinal Health, McKesson) 
• Establishes stricter oversight of controlled substance distribution 
• Standardizes wholesaler responsibilities: 
  • Customer due diligence 
  • Data monitoring and analysis 
  • Ordering thresholds 
  • Suspicious order reporting 
   

What is a CSMP Audit? 

• Wholesaler-led review of pharmacy controlled substance practices 
• Can be routine (random) or triggered by risk factors 
• Typically occurs every 1–2 years 

Core Audit Components 

• Pharmacy Questionnaire: Licenses, registrations, ownership, compliance history 
• Pharmacy Customer Data (PCD): 3 months of dispensing data (if requested) 
• On-site or Virtual Audit: Staff interviews, policy review, red flag analysis 

Common Audit Triggers 

• New pharmacy onboarding 
• Request for threshold increase 
• Identified or suspected diversion red flags 
• Routine/random selection 

Highly Monitored Controlled Substances 

• Oxycodone, Hydrocodone, Morphine 
• Fentanyl, Methadone, Hydromorphone 
• Alprazolam, Carisoprodol, Tramadol 

Key Red Flags 

• High ratio of controlled vs. noncontrolled prescriptions 
• Rapid growth in controlled substance dispensing 
• Repeated attempts to exceed ordering thresholds 
• Unusual strengths, formulations, or quantities 
• High volume of cash prescriptions 
• Out-of-area patients or prescribers 
• Prescribers contributing disproportionate volume 
• Pattern prescribing (same drug, quantity, directions) 
• Prior regulatory or disciplinary actions 

Pharmacy Expectations 

• Respond promptly and professionally to all requests 
• Provide complete and accurate data 
• Maintain awareness of dispensing trends 
• Be prepared to explain: 
  • Business model 
  • Prescriber relationships 
  • Controlled substance practices 
   

Consequences of Noncompliance 

• Loss of controlled substance ordering privileges 
• Suspension often lasting up to 1 year 
• Significant disruption to pharmacy operations and patient care 

Bottom Line 

• CSMP audits are high-impact and unavoidable 
• Ongoing monitoring, documentation, and staff awareness are essential 
• Proactive compliance helps prevent audits, flags, and supply disruptions 

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.