DEA Requirements for Schedule IV Controlled Substances
Schedule IV controlled substances require specific prescribing, record-keeping, and security measures to ensure appropriate use and minimize diversion risk.
Prescription Requirements
- Schedule IV medications require a valid DEA registration number from the prescriber 1, 2
- Prescriptions for Schedule IV medications must include:
- Patient's full name and address
- Prescriber's full name, address, and DEA registration number
- Drug name, strength, dosage form, and quantity
- Directions for use
- Date of issue
- Prescriber's signature 3
- Schedule IV prescriptions may be issued orally, in writing, or by electronic transmission where permitted by state law 3
- Schedule IV prescriptions may be refilled up to 5 times within 6 months from the date of issue, after which a new prescription is required 2
Record-Keeping Requirements
- Prescribers must maintain complete and accurate records of all Schedule IV controlled substances dispensed directly to patients 1
- Records must be kept for at least 2 years and be readily retrievable for DEA inspection 3
- Pharmacies must maintain accurate dispensing records for Schedule IV medications 2
Security Requirements
- Schedule IV medications must be stored in a secure location to prevent theft or diversion 1
- Any theft or significant loss of Schedule IV medications must be reported to the local DEA office 2
Special Considerations for Telemedicine
- The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires at least one in-person evaluation before prescribing controlled substances via telemedicine 3
- The DEA has indicated it does not intend to interfere with legitimate prescribing of controlled substances during telemedicine practice, though further rules on telemedicine prescribing are pending 3
- Some states have enacted legislation to specifically allow prescribing of controlled substances during telemedicine practice 3
Common Schedule IV Medications
- Benzodiazepines (alprazolam, lorazepam, clonazepam) 1
- Non-benzodiazepine sedative-hypnotics (zolpidem, eszopiclone, zaleplon) 3, 2
- Some weight loss medications (phentermine) 3
- Other medications that have been specifically placed into Schedule IV by the DEA, such as zopiclone 4, suvorexant 5, and fospropofol 6
Important Considerations
- Schedule IV substances have a lower potential for abuse compared to Schedule II and III substances, but still require careful monitoring 1, 2
- Physical and psychological dependence can occur with Schedule IV medications, particularly with extended use or at higher doses 1
- Prescribers should be aware of both federal DEA requirements and state-specific regulations, which may be more restrictive 3
- Pharmacists with collaborative practice agreements may obtain DEA registration to prescribe controlled substances in some settings 7
Potential Pitfalls to Avoid
- Failing to check state-specific regulations that may be more restrictive than federal requirements 3
- Prescribing Schedule IV medications without appropriate documentation or medical necessity 1
- Not recognizing that some medications may be temporarily rescheduled by the DEA based on public safety concerns 8
- Overlooking the need for patient monitoring for signs of dependence, tolerance, or misuse 1, 2