Important Notice: Gabapentin Becomes a Schedule 5 Controlled Substance in Kentucky

Amendments to 902 KAR 55:035 were finalized and adopted on March 3, 2017. The regulation may be accessed on the Kentucky Legislative Research Commission website at: http://www.lrc.ky.gov/kar/902/055/035reg.htm

For questions, please call the Drug Enforcement and Professional Practices Branch at 502-564-7985.
Effective July 1, 2017, all gabapentin products will be Schedule 5 controlled substances in Kentucky.
All applicable provisions of KRS Chapter 218A, 902 KAR Chapter 55 and other licensure board regulations will apply to gabapentin. Please review all controlled substance security, storage, record keeping, inventory, prescribing and dispensing requirements. This document is not intended to be an all-inclusive overview.
Authorized practitioners MUST be properly licensed and registered with the DEA to order the dispensing of a controlled substance. Therefore, only DEA registered practitioners may issue prescriptions for gabapentin or order the direct administration or dispensing of gabapentin to a patient.

After July 1, 2017, any existing orders for gabapentin (including Rx refills) issued by a practitioner WITHOUT a DEA registration will no longer be valid and MAY NOT be administered or dispensed. Existing orders for gabapentin that were issued by a practitioner WITH a DEA registration will not be affected, except that existing gabapentin prescriptions will expire after 5 refills or 6 months from the date the prescription was issued, whichever comes first. It will not be legal to distribute Gabapentin samples in Kentucky. Please note that Physician Assistants (PAs) are not authorized to prescribe controlled substances in Kentucky.

How does moving gabapentin to Schedule 5 affect prescribing practitioners?
• Advance Practice Registered Nurses will no longer be able to prescribe gabapentin unless they have a DEA license.
• Gabapentin dispensed in Kentucky will appear on KASPER reports.
• Prescribers must comply with the legal standards for prescribing controlled substances promulgated by their licensure board.
 • Prescribers may issue written or oral prescriptions for gabapentin.
• Written prescriptions must be issued on a controlled substance Security Prescription Blank or transmitted to a pharmacy using a certified electronic prescribing application.
• Prescriptions for gabapentin may include up to 5 refills and expire 6 months after the date issued.
• Prescriptions for gabapentin may not be pre-signed or post-dated.

How does moving gabapentin to Schedule 5 affect dispensing practitioners?
• Only authorized practitioners may directly dispense controlled substances to patients. In Kentucky, no mid-level practitioners are authorized to directly dispense controlled substances.
• Practitioners who directly dispense gabapentin FROM their stock TO a patient, including both administering and dispensing, shall transmit the required dispensing data to the KASPER system in accordance with KRS 218A.202 and 902 KAR 55:110.
• Practitioners must perform an initial gabapentin inventory on or after July 1 but before July 30, 2017.
• Practitioners must include gabapentin in their biennial controlled substance inventory.
• Practitioners must comply with the legal standards for dispensing controlled substances that were promulgated by their licensure board.

How does moving gabapentin to Schedule 5 affect pharmacies?
• Pharmacies must perform an initial gabapentin inventory on or after July 1, but before July 30, 2017.
• Pharmacies must include gabapentin in their biennial controlled substance inventory.
• Dispensing data for gabapentin must be transmitted to the KASPER system in accordance with KRS 218A.202 and 902 KAR 55:110.
 • Gabapentin dispensing data will not successfully upload to KASPER if the prescriber does not have a DEA number, so please ensure that your computer system reflects the correct prescriber data.
• Refills on existing gabapentin prescriptions MAY be filled if the prescriber is authorized to prescribe Schedule 5 controlled substances AND the prescriber has a DEA number AND the prescription has
 ot been refilled more than 5 times AND the prescription was written less than 6 months prior.

Filed under: General Problems