Schedule 3N Controlled Substances
Schedule 3N drugs are controlled substances with moderate to low potential for physical and psychological dependence, specifically those containing narcotic (N) components, that are subject to regulatory controls under the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Classification Characteristics
Schedule 3 controlled substances are defined by three key criteria:
- Lower potential for abuse than Schedule 1 and 2 substances
- Currently accepted medical use in treatment in the United States
- Abuse may lead to moderate or low physical dependence or high psychological dependence 1
Common Schedule 3N Medications
Schedule 3N specifically refers to narcotic-containing medications within Schedule 3:
- Hydrocodone combination products (containing 15 mg or less of hydrocodone)
- Hydrocodone/acetaminophen (e.g., Vicodin, Lortab)
- Hydrocodone/ibuprofen (e.g., Vicoprofen)
- Codeine combination products
- Codeine/acetaminophen (when containing moderate amounts of codeine) 2
Regulatory Controls for Schedule 3N Drugs
Schedule 3N medications are subject to specific regulatory requirements:
- Prescriptions may be written or oral (called in to pharmacy)
- Prescriptions may be refilled up to 5 times within 6 months
- Prescriber must have valid DEA registration
- Detailed record-keeping required by pharmacies
- Less restrictive than Schedule 2 drugs which require written prescriptions and prohibit refills 1
Clinical Considerations
When prescribing Schedule 3N medications:
- For acute pain, Schedule 3N medications like hydrocodone/acetaminophen have similar efficacy to Schedule 2 opioids at equianalgesic doses 2
- Studies have shown no difference in pain relief between Schedule 2 oxycodone combinations and Schedule 3 hydrocodone combinations for conditions like acute low back pain 2
- Consider the lowest practical dose for a limited duration (e.g., 1 week) to minimize risk of misuse, abuse, or diversion 2
Comparison to Other Schedules
- Schedule 1: No accepted medical use, high abuse potential (e.g., heroin, LSD)
- Schedule 2: High abuse potential but with accepted medical use (e.g., morphine, oxycodone, fentanyl, hydromorphone)
- Schedule 3N: Moderate abuse potential with accepted medical use, containing narcotic components
- Schedule 4: Lower abuse potential (e.g., benzodiazepines, tramadol)
- Schedule 5: Lowest abuse potential of controlled substances (e.g., certain cough preparations with limited codeine) 3
Important Notes
- Schedule classifications may change over time based on reassessment of abuse potential
- There have been calls to reclassify hydrocodone combination products from Schedule 3 to Schedule 2 due to increasing abuse concerns 2
- In fact, in October 2014 (after some of these guidelines were published), hydrocodone combination products were reclassified from Schedule 3 to Schedule 2
- Some substances like anabolic steroids are also classified under Schedule 3, but these are not considered Schedule 3N as they lack narcotic components 4
Schedule 3N medications represent an important category of controlled substances that balance therapeutic utility with appropriate regulatory controls to minimize potential for abuse and diversion.