Controlled Substances SOPs

Controlled substances require clear policies for prescribing, handling, storage, documentation, and access. Jackson LLP drafts customized standard operating procedures (SOPs) that give your practice a consistent framework for managing controlled substances and preparing for DEA scrutiny.

Customized Controlled Substances SOPs

Controlled-substances requirements can affect multiple parts of your practice. Written SOPs can establish consistent processes for the clinicians and staff who prescribe, handle, store, or otherwise manage controlled substances.

Jackson LLP drafts controlled-substances SOPs tailored to your practice, the medications you use, your staffing structure, and applicable federal and state requirements.

Depending on your practice’s needs, your SOPs may address:

• Prescribing policies and procedures
• Controlled-substance storage and security
• Access and authorization
• Medication handling and inventory
• Documentation and recordkeeping
• Prescription and dispensing procedures
• Disposal and waste procedures
• Monitoring for loss, diversion, or unauthorized access
• Staff responsibilities
• Internal compliance reviews
• Procedures for responding to discrepancies or other compliance concerns

Your SOPs can be developed for a specific controlled substance or as part of a broader controlled-substances compliance program.

Controlled-Substances Storage and Handling Policies

The physical security of controlled substances is an important part of compliance. Your practice should have written procedures addressing who can access controlled substances, how they are stored, and how access and handling are documented. Those procedures should address DEA-compliant controlled substances storage, along with inventory controls, recordkeeping, and processes for addressing missing or improperly handled medications.

Jackson LLP can incorporate your practice’s storage and handling procedures into a broader controlled-substances SOP.

Controlled-Substance Prescribing Policies

Prescribing controlled substances can create additional regulatory obligations for your practice. Your written policies should give clinicians a consistent framework for prescribing while accounting for applicable federal and state requirements.

Depending on your practice and prescribing activities, SOPs may address:

• Patient evaluation and prescribing criteria
• Prescription documentation
• Required patient records
• Prescription monitoring requirements
• Refill procedures
• Communication with pharmacies
• Medication agreements and patient acknowledgments
• Circumstances requiring additional review or consultation
• Documentation of prescribing decisions
• Procedures for identifying potential misuse or diversion

The appropriate requirements can vary based on the controlled substance, the clinician’s license and authority, and the state where the practice operates. We draft your SOPs around those considerations rather than relying on a one-size-fits-all policy.

Preparing Your Practice for a DEA Audit

A DEA inspection can put your practice’s controlled-substances procedures under close scrutiny. Written SOPs can give your team a consistent process for maintaining the records, security measures, and internal controls that support compliance.

Jackson LLP can develop SOPs that address the areas your practice should have organized before an inspection, including storage, access, handling, prescribing, documentation, and internal review procedures.

SOPs That Fit Your Practice

Your controlled-substances policies should reflect how your practice operates. Jackson LLP considers your practice structure, the controlled substances you prescribe or maintain, the professionals involved, and the applicable legal requirements when drafting your SOPs. If you already have policies in place, we can also review and revise them when your prescribing practices, staffing, or regulatory requirements change.

Controlled-substances SOPs can also form part of a broader healthcare compliance plan addressing the policies and procedures your practice needs to operate within applicable legal requirements.

Schedule a Consultation for Your Controlled Substances SOPs

Your controlled-substances policies should give your clinicians and staff clear procedures for prescribing, handling, storage, documentation, and access.

Jackson LLP drafts customized controlled-substances SOPs based on your practice and its specific compliance needs. Schedule a consultation to discuss the policies and procedures your practice needs.

Frequently Asked Questions