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Controlled Substance Inventory & Recordkeeping Guide

A clear overview of how pharmacies maintain accurate inventories, document controlled substances, and meet federal recordkeeping expectations.

RELATED LINKS 

For additional resources to support pharmacy controlled substance ordering and inventory compliance click HERE.  

 

FULL ARTICLE 

Maintaining accurate inventory and thorough records of controlled substances is a foundational requirement for pharmacy compliance. Proper inventory practices help prevent diversion, ensure accountability, and support audit readiness. 

 

While federal regulations establish baseline requirements, pharmacies should also be aware that state laws may impose additional or more stringent standards. 

 
 

Inventory Responsibility & Staff Awareness 

All pharmacy staff play a role in maintaining controlled substance accountability. 

  • Staff should be committed to maintaining a complete and accurate inventory at all times  
  • Any discrepancies must be reported immediately for investigation  
  • Ongoing training ensures staff understand inventory procedures and compliance expectations  

 
 

What Constitutes an Inventory 

A controlled substance inventory is a complete and accurate physical count of all controlled substances under the pharmacy’s control. 

This includes: 

  • Active stock inventory  
  • Medications set aside for reverse distribution (unsaleable items)  
  • Products designated for return to wholesalers  
  • Prescriptions prepared and waiting for patient pickup (will-call inventory)  

Inventories must be maintained in a written, typewritten, or printed format and stored at the registered pharmacy location. 

 
 

Required Inventory Components 

Each inventory record must include detailed and specific information: 

  • Date the inventory is taken  
  • Whether the inventory is conducted at the start or end of business  
  • Drug name and strength (e.g., 10 mg tablet)  
  • Dosage form (tablet, capsule, etc.)  
  • Package size (e.g., 100-count bottle)  
  • Number of containers on hand  
  • Total quantity of each controlled substance  

 
 

Counting Requirements 

  • Schedule II Substances  
    • Require an exact physical count  
  • Schedule III–V Substances  
    • Estimated counts are allowed if the container holds fewer than 1,000 dosage units  
    • Exact counts are required if containers exceed 1,000 units  
    • Best practice: perform exact counts for all controlled substances whenever possible  

 
 

Handling Unsaleable Inventory 

Controlled substances that cannot be dispensed must still be included in inventory records. 

These should be clearly identified as unsaleable, including items that are: 

  • Expired  
  • Damaged or deteriorated  
  • Recalled  
  • Unused or unwanted  

Proper designation ensures accurate tracking and supports compliant disposal or return processes. 

 
 

Documentation & Record Organization 

Each inventory must also include: 

  • Pharmacy name, address, and DEA registration number  
  • Signature of the individual responsible for completing the inventory  

Additionally: 

  • Schedule II inventories must be separated from Schedule III–V inventories  
  • Records must be readily retrievable for inspection  
  • All inventory records must be maintained on-site for at least 2 years  

Inventories do not need to be routinely submitted to regulatory agencies but must be available upon request. 

 
 

Maintaining detailed and accurate controlled substance inventory records is essential for compliance, operational integrity, and patient safety. By following consistent inventory procedures and ensuring proper documentation, pharmacies can reduce risk, detect discrepancies early, and remain fully prepared for regulatory inspections. 

 

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.