Authorized Collector Program: Safe Disposal of Controlled Substances

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The Secure and Responsible Drug Disposal Act of 2010 allows retail pharmacies and other authorized entities to collect controlled substances from patients (ultimate users) for safe disposal. Participating as an authorized collector helps prevent drug misuse, abuse, and diversion while promoting community safety. 

This guide outlines how pharmacies can establish and maintain compliant drug disposal programs. 

Who Can Be an Authorized Collector 

Authorized collectors may include: 

• Retail pharmacies  
• Hospitals/clinics with on-site pharmacies  
• Narcotic treatment programs  
• Manufacturers, distributors, and reverse distributors  

Collection may occur: 

• At the registered pharmacy location  
• At long-term care facilities (LTCFs) serviced by the pharmacy  

Authorized collectors may accept controlled substances from: 

• Ultimate users (patients)  
• Individuals legally handling a deceased patient’s property  
• LTCFs on behalf of residents  

Becoming an Authorized Collector 

To participate: 

• Modify your DEA registration to include authorized collector status  
• Maintain active registration and renew as required  

If discontinuing participation: 

• Notify the DEA and properly discontinue collection activities  

Collection Receptacle Requirements 

Location 

• Retail pharmacy:  
  • Must be inside the pharmacy  
  • Must be visible to staff  
• Long-term care facility:  
  • Must be in a secure, regularly monitored area  

Authorized Collection Practices 

• Patients must place items directly into the receptacle  
  • Staff cannot handle or accept drugs for deposit  
• Pharmacies without onsite destruction:  
  • May install and manage receptacles  
  • Must arrange timely disposal of sealed liners  

Collection Receptacle Design 

Outer Container Requirements 

• Permanently affixed to prevent removal  
• Locked and substantially constructed  
• Includes a small deposit opening that prevents retrieval  
• Displays required signage indicating acceptable items  
• Secured or inaccessible when staff are not present  

Inner Liner Requirements 

• Waterproof, tamper-evident, and tear-resistant  
• Removable and sealable without handling contents  
• Opaque when sealed (contents not visible)  
• Clearly marked with size  
• Assigned a unique identification number for tracking  
• Access restricted to authorized employees  

Handling Inner Liners 

Installation & Removal 

• Must be performed by two employees  
  • At LTCFs:  
    • Two pharmacy employees, or  
    • One pharmacy employee + one LTCF supervisor  

Sealing 

• Inner liners must be sealed immediately upon removal  
• Two employees must witness and document the process  

What Can Be Collected 

Collection receptacles may accept: 

• Schedule II–V controlled substances  
• Non-controlled prescription medications  

Not permitted: 

• Schedule I substances  
• Illicit or unlawfully possessed substances  

Important: 

• Once deposited, contents:  
  • Cannot be sorted, counted, or handled individually  

Inner Liner Recordkeeping Requirements 

Accurate documentation is essential for compliance. The following must be tracked: 

Unused Liners 

• Date acquired  
• Unique ID number  
• Size  

Installation 

• Date and location  
• Inner liner ID and size  
• DEA registration number  
• Names and signatures of both employees  

Removal 

• Date and location  
• Inner liner ID and size  
• DEA registration number  
• Names and signatures of both employees  

Transfer to Storage 

• Date transferred  
• Inner liner ID and size  
• Names and signatures of both employees  

Transfer for Destruction 

• Date of transfer  
• Reverse distributor name, address, and registration number  
• Inner liner ID and size  
• DEA registration number  
• Names and signatures of both employees  

Record Retention 

• All inner liner and disposal records must be:  
  • Accurate  
  • Organized  
  • Readily retrievable  
• Maintain records for at least 2 years  
• Ensure availability for inspection by regulatory authorities  

Best Practices for Compliance 

• Regularly inspect receptacles for security and integrity  
• Train staff on proper handling and documentation procedures  
• Maintain strict access controls for liners and records  
• Schedule routine pickups and disposal to avoid overflow  
• Audit records periodically for completeness and accuracy  

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.