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CMEA Overview: Managing Pseudoephedrine (PSE) Sales in Pharmacies

A clear, practical overview of training, sales limits, storage, documentation, and reporting requirements for over-the-counter PSE products under federal law.

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For additional resources to support pharmacy licensing and registration click HERE.  

 

FULL ARTICLE 

The Combat Methamphetamine Epidemic Act (CMEA) establishes strict federal requirements for the sale of over-the-counter products containing ephedrine, pseudoephedrine (PSE), and phenylpropanolamine (PPA). These substances can be used in the illegal manufacture of methamphetamine, making compliance essential for all pharmacies that stock or sell these products. 

This guide outlines the key responsibilities pharmacies and staff must follow to ensure compliance, including training, certification, sales controls, storage, and reporting obligations. 

 
 

Employee Training Requirements 

All pharmacy staff involved in the sale of PSE-containing products must complete training: 

  • Initial and Annual Training 
    Training must occur at hire and at least annually thereafter. Pharmacies may use DEA-provided materials or equivalent programs that meet federal requirements.  
  • Training Documentation 
    Completion records must be maintained and readily accessible. Regular review ensures all staff remain compliant and up to date.  

 
 

DEA Self-Certification 

Pharmacies must complete a self-certification process with the DEA before selling PSE-containing products. 

  • Initial & Annual Certification 
    Certification must be completed after all staff training is finished and renewed annually.  
  • Certificate Handling 
    After certification:  
    • Print the certificate  
    • Display it in the pharmacy  
    • Store it with regulatory records for at least 2 years  
  • Expiration Monitoring 
    Certification status should be reviewed regularly. Renewal should occur before expiration to avoid interruptions in PSE sales.  
  • Important Restriction 
    Pharmacies may not sell PSE-containing products without an active DEA self-certification—even if dispensing only via prescription.  

 
 

Sales Limits & Product Controls 

Strict limits apply to how much PSE a customer can purchase: 

  • Daily Limit: 3.6 grams  
  • 30-Day Limit:  
    • 9 grams (in-store purchases)  
    • 7.5 grams (mail-order purchases)  
  • Packaging Requirements  
    • Non-liquid forms must be packaged in blister packs (no more than two dosage units per blister)  
    • If blister packaging is not feasible, unit-dose packets must be used  

 
 

Storage Requirements 

All PSE-containing products must be securely stored: 

  • Behind the pharmacy counter or  
  • In a locked cabinet that prevents unauthorized access  

This helps reduce theft and ensures regulatory compliance. 

 
 

Sales Process & Logbook Requirements 

Each sale of PSE-containing products must be documented. 

  • Required Information 
    Pharmacies must maintain a written or electronic logbook that includes:  
    • Purchaser name and address  
    • Purchaser signature  
    • Product name  
    • Quantity sold  
    • Date and time of transaction  
    • The logbook or electronic list must include a notice to purchasers that entering false statements or misrepresentations in the logbook may subject purchasers to criminal penalties under 18 U.C.S. § 1001. 
  • Customer Verification 
    Customers must:  
    • Present valid, government-issued photo identification  
    • Sign the logbook  
  • Record Retention 
    Logbook records must be maintained for at least 2 years.  
  • Privacy & Access 
    Logbook information may only be shared with authorized law enforcement or for product recalls.  

 
 

Acceptable Identification 

Customers must provide valid, unexpired identification. Common acceptable forms include: 

  • Government-issued photo ID (e.g., driver’s license, passport)  
  • Military ID or federal/state-issued identification  
  • Certain school or institutional IDs (depending on age and state requirements)  

Pharmacies should verify state-specific rules for acceptable identification. 

 
 

Theft, Loss, & Suspicious Activity Reporting 

Theft or Loss 

If a significant or unusual loss occurs: 

  • Notify the local DEA Diversion Office immediately  
  • Contact the State Board of Pharmacy  
  • Notify local law enforcement if necessary  
  • Submit a written report (DEA Form 107) within 15 days  

Suspicious Transactions 

Transactions must be reported if they involve: 

  • Unusual quantities  
  • Suspicious payment methods  
  • Circumstances suggesting illegal use  

Reports should be made promptly to the DEA, followed by a written report within 15 days. 

 
 

Maintaining compliance with CMEA requirements is critical to preventing misuse of PSE-containing products and ensuring lawful pharmacy operations. With proper training, accurate recordkeeping, secure storage, and timely reporting, pharmacies can confidently meet regulatory expectations while supporting public safety. 

 

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.