Tennessee Pharmacists Association

Gabapentin Becomes Schedule V

June 21, 2018

Effective July 1, 2018, all gabapentin products will be Schedule V controlled substances in the state of Tennessee. It is known under the brand names Neurontin, Horizant, Gralise, Gabarone, and Fanatrex. Gabapentin is often used to potentiate the effects of opioids and potentially increases the risk of overdose death when used in combination with them. The US has seen substantial increases in the rate of gabapentin prescribing and abuse, leading to this change. The new scheduling of gabapentin will not only affect patients, but pharmacists and pharmacy technicians as well.

Patients:

  • Gabapentin will be illegal for someone to possess without a prescription. Those found in possession of it without a prescription will be subject to a Class E felony and fines of no more than $5,000.
  • Gabapentin refill dates will be left to the discretion of the practicing pharmacist and/or pharmacy and presumably follow current refill practices of controlled substances.

Pharmacies:

  • Inventory of gabapentin must be performed after close of business on June 30, 2018, or prior to opening of business on July 1, 2018, the effective date of the new scheduling. Thereafter, a new inventory must be performed at least every two years and should be added to the pharmacy’s biennial inventory.
  • Information must be submitted for each gabapentin prescription to the controlled substance monitoring database (CSMD) each business day, no later than the close of business the next day.
  • Transferring of gabapentin prescriptions between pharmacies may only be done on a one-time basis. For pharmacies who share an electronic database, it can be transferred up to the maximum number of refills, if the pharmacy software allows.
  • Required documentation on gabapentin prescription should match other controlled substances in accordance with the requirements outlined by the DEA and state of Tennessee.
    • Medical or prescription order serial number
    • Date of issuance of the medical or prescription order
    • Patient’s name and address
    • Prescriber’s name, address, and DEA registration number
    • Product name, strength, dosage form, and quantity prescribed
    • Directions for use, and labeling instructions
    • Refill instructions
    • Date of dispensing, quantity dispensed, and identity (name, initials, or identification code) of the dispensing pharmacist for the original dispensing and each refill.
  • While the DEA is unclear on guidance for refills on Schedule V prescriptions, the Tennessee Pharmacists Association (TPA) encourages pharmacies to adopt a policy of filling or refilling no more than six months after the date the prescription was issued, and refilling no more than five times. (CFR 1306.22CFR 1306.23)
  • Pursuant to Federal law, partial filling of gabapentin is permissible as long as the total quantity does not exceed the total quantity prescribed and no dispensing occurs after six months after the date the prescription was issued.
  • Gabapentin should be filed with other controlled substances in accordance with the requirements outlined by the DEA and state of Tennessee.
  • Gabapentin should be disposed of in a similar manner to other controlled substances in accordance with the requirements outlined by the DEA and state of Tennessee.

If valid refills remain on prescriptions dated before July 1, 2018, they are able to be filled for 6 months, but should be reported to the CSMD and follow other policies on filling of controlled substances. Prescriptions dated on or after July 1, 2018, should be treated as controlled substance prescriptions and contain all controlled substance requirements listed above.

Remember to review all controlled substance record keeping, inventory, prescribing and dispensing requirements as outlined by the DEA and state of Tennessee.