FDA Urges Rescheduling of Hydrocodone

The Food and Drug Administration (FDA) believes stricter oversight is needed for hydrocodone-containing drug products to curb abuse and misuse, triggering its statement Thursday that hydrocodone products should be moved to Schedule II status by the Drug Enforcement Administration (DEA). Specifically, FDA’s coordinating with its overarching Department (Health and Human Services/HHS) to work with the DEA to initiate the scheduling process change this December.

Citing misuse and abuse of opioid drugs, FDA says it’s been challenged with “determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”

The AVMA has advocated for several years the need for adequate veterinary medical access to opioids including hydrocodone, for the health of our animal patients, while recognizing the need for protecting the public health. Our most recent letter to the FDA’s Drug Safety and Risk Management Committee underscores veterinarians’ needs for hydrocodone in clinical veterinary practice, while also highlighting the minimal diversion risk associated with misuse and abuse of opioids used in veterinary medicine.

Please stay tuned for more, as AVMA gains additional updates on the proposed scheduling changes for hydrocodone products.

2 thoughts on “FDA Urges Rescheduling of Hydrocodone

  1. Jennifer

    I dont think this will greatly impact private practice significantly. Other C-II drugs are already routinely used in practice such as hydryomorphone, fentanyl and morphine. For our practice if hydrocodone goes to C-II it will not negatively impact our practice. Feel free to contact me

    Fred Gingrich