Hydrocodone-containing products set to become Schedule II drugs on Oct. 6

Beginning Oct. 6, all hydrocodone-containing products (HCPs) will be classified as Schedule II drugs by the DEA.

According to a blog entry from Lynne White-Shim, DVM, assistant director in the AVMA's Scientific Activities Division, the DEA's new final rule will eliminate the divide that currently categorizes some HCPs as Schedule II substances and others as Schedule III.

The final rule is based on findings presented by the United States Department of Health and Human Services (HHS) to the DEA in a report titled ‘‘Basis for the Recommendation to Place Hydrocodone Combination Products in Schedule II of the Controlled Substances Act,’’ in which the HHS reached the conclusion that HCPs have a high potential for abuse.

Impact on animal hospitals

Because HCPs are sometimes used to control coughing and manage pain control in dogs, the AVMA said that animal hospitals need to ensure they are registered with the DEA to legally handle Schedule II substances on or before Oct. 6.

When handling HCPs, hospitals will need to follow the DEA's Schedule II requirements covering aspects such as security protocols, labeling and packaging, inventory, recordkeeping, and reporting. The AVMA specifically recommended that animal hospitals:

  • Use Form 222 to order HCPs and secure storage of Form 222.
  • If dispensing from the clinic: check state rules that might limit the dispensed amount to a 30-day supply at one time.
  • If prescribing: provide a written prescription (not phone or fax, unless it's for a short-term emergency, followed by sending a prescription in written form within seven days) with zero refills. The prescription, or set of prescriptions, can provide up to a 90-day supply maximum for the client to have dispensed at a pharmacy of their choice.
  • Maintain detailed records in a physical file for Schedule II, separate from Schedule III-V records.
  • Keep accurate and detailed inventory records for HCPs and other Schedule II substances.

The DEA also stated in the final rule that HCP prescriptions issued before Oct. 6, 2014, and authorized for refilling may be dispensed in accordance with 21 CFR 1306.22–1306.23, 1306.25, and 1306.27, if dispensing occurs before April 8, 2015.

Additional resources

Veterinary Compliance with the DEA and the Controlled Substance Act (AVMA resource)

NEWStat Legislation & regulation