Combat Methamphetamine Epidemic Act (CMEA) – Key Tips for Compliance

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The Combat Methamphetamine Epidemic Act (CMEA) sets federal requirements for the sale, storage, and tracking of certain over-the-counter products containing pseudoephedrine, ephedrine, and phenylpropanolamine. Pharmacies must follow these rules carefully to prevent diversion and avoid penalties. 

Key Requirements for CMEA-Regulated Products 

1. Product Placement  
   • All CMEA-regulated products must be stored behind the counter or in a locked cabinet to prevent unauthorized access.  
2. Customer Identification and Logbook  
   • Sellers must verify the identity of each purchaser.  
   • Maintain a log of each sale including:  
     • Purchaser’s full name and address  
     • Purchaser’s signature  
     • Product sold  
     • Quantity sold  
     • Date and time of the sale  
3. Record Retention  
   • Logbooks, whether paper or electronic, must be retained for at least 2 years.  
4. Employee Training and Certification  
   • Employers must ensure all staff are trained on CMEA requirements.  
   • Pharmacies must self-certify with the DEA that training has been completed.  
5. Sale Limits  
   • Daily limit: 3.6 grams per regulated product per purchaser  
   • Monthly limit: 9 grams per regulated product per purchaser  

Reporting Requirements 

• Suspicious Orders  
  • Report verbally to the DEA as soon as possible.  
  • Follow up with a written report within 15 days via the DEA Diversion Website.  
• Loss or Disappearance of Listed Chemicals  
  • Report verbally at the earliest opportunity.  
  • File DEA Form 107 within 15 days after discovery on the DEA Diversion Website.  

Common Inspection Findings & Best Practices 

1. Warning Notice Not Displayed  
   • Pharmacies often fail to display the required customer warning notice.  
   • Tip: Reference 21 CFR 1314.35 / 1340.30(d) for correct wording and placement.  
2. Incomplete Employee Training Records  
   • Employers may not be able to locate all employee documentation.  
   • Tip: Print and maintain training records for every employee in your regulatory file.  
3. Expired DEA Self-Certification  
   • Pharmacies sometimes fail to renew self-certification but continue stocking products.  
   • Tip: Verify DEA self-certification monthly. Renew on the DEA Diversion Webpage and keep copies posted in the pharmacy and in regulatory records.  
4. Incomplete or Inaccurate Logbook Records  
   • Records may lack purchaser information or product details.  
   • Tip: Audit logbooks monthly for completeness. If using electronic logs, ensure all staff know how to access the log and display the warning notice.  

Penalties for Noncompliance 

Violating CMEA requirements may result in civil penalties of $18,000 or $80,000 per violation, depending on the severity and frequency of the violation. 

Resources 

• Full CMEA regulations: DEA Combat Methamphetamine Epidemic Act  
• Summary guidance: Pharmacist DEA Manual  

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.