Xylazine: What’s Next?

The federal government announced an action plan this week to address illegitimate drug use of this veterinary sedative

More than 3 months have passed since The Combating Illicit Xylazine Act (HR 1839/S 993)1 was introduced into Congress on March 28, 2023. If passed, this act would provide law enforcement with the tools to go after those trafficking in illicit xylazine and apply the same penalties that are found under Schedule III of the federal Controlled Substances Act. At the same time, it would not schedule the legitimate veterinary uses of xylazine that would continue to be regulated as a prescription drug under the Food, Drug, and Cosmetic Act. Any diversion of the veterinary drug for human use would fall within the definition of illicit use and be subject to penalties.

On July 11, 2023, The White House announced its Fentanyl Adulterated or Associated with Xylazine Response Plan consisting of 6 pillars and calling for whole-government actions such as testing, research, treatment and regulatory controls. The plan did not include any updates on the Combating Illicit Xylazine Act.

Increased Concerns

Xylazine has been detected in illicit drug supplies across all 50 states and is currently the leading substance used to adulterate fentanyl. In addition to concerns surrounding the fatal human health crisis xylazine-laced fentanyl has created, veterinary professionals are also faced with the threat of their legitimate supply of xylazine required for patient care potentially being disrupted as access, manufacturing, and distribution of xylazine lies in the balance, as they continue to be debated.

Federal Scheduling

There is agreement that the need to ensure legitimate use and appropriate regulatory controls of xylazine is a priority. The White House’s fact sheet reiterates that the administration wants to “ensure we are using every lever we have to protect public health and public safety.” One of the ways to do that is through legislative scheduling. As federal legislation remains in limbo, many are asking why as well as what is really being done to fix this.

Xylazine’s existing “unscheduled” status means that penalties for illegitimate use are limited and subject to much less scrutiny from law enforcement than scheduled controlled substances. Without legislation enacted, executive powers are limited. If xylazine becomes a DEA Schedule III controlled substance it will enforce sanctions making the illicit sales and trafficking of xylazine more difficult. Federal scheduling is not a “fix all” but it is a key component. The Combating Illicit Xylazine Act would provide a national baseline for enacting critical measures to combat the widespread illicit use and trafficking of xylazine with the goal of preventing xylazine-related deaths while protecting the licit supply of xylazine for veterinary use.

State Scheduling

Florida was the first state to schedule xylazine by designating it a schedule I controlled substance in 2018, a decision that is allowing Florida to act against illicit xylazine trafficking. On June 27, Attorney General Ashley Moody’s Office of Statewide Prosecution announced that it is set to prosecute 12 individuals involved with a fentanyl, xylazine and cocaine trafficking ring that was shut down by law enforcement in the Orlando, Florida area. The investigation uncovered that the drugs were being transported to Florida from a supplier in New Jersey. Twelve people were arrested and are being charged with a combined 52 felony counts carrying a 25-year mandatory minimum prison sentence under Florida law.4

After The Combating Illicit Xylazine Act was introduced on March 28, 2023, other states began scheduling xylazine as follows:

State Xylazine Scheduling Snapshot:

West Virginia designated xylazine a schedule IV-controlled substance on March 29, 2023.

Ohio designated xylazine a schedule III-controlled substance on March 29, 2023

New Jersey introduced Senate No. S3902 on June 1, 2023, to take immediate effect classifying xylazine as Schedule III dangerous controlled dangerous substance (CDS), except when licitly acquired, prescribed, administered, or dispensed by a veterinarian. Delaware issued a temporary order on June 2, 2023 scheduling xylazine as a schedule III controlled substance for an initial 120 days, which can be extended an additional 60 days with options allowing the General Assembly to vote and make the restrictions permanent.Additionally, on June 28, 2023 Delaware Lt. Governor Bethany Hall-Long, PhD, RN, announced a pilot program to distribute the nation’s first combination fentanyl and xylazine test strip–a groundbreaking development as fentanyl and xylazine test strips have previously been 2 separate tests.

Pennsylvania temporarily added xylazine to the list of schedule III drugs on June 3, 2023, under Pennsylvania’s Controlled Substance, Drug, Device, and Cosmetic Act. The order is effective for 1 year and the PA Secretary of Health can extend the temporary scheduling for up to 1 additional year.

States with pending xylazine legislation include New York, Illinois, Rhode Island and Louisiana.

What’s Next?

One of the plan’s 6 pillars is Regulatory Control and Monitoring Options that states, “the US government should assess regulatory options to disrupt the production, distribution, illegal sale and trafficking (even if not scheduled), and exposure to illicit xylazine.” The plan further calls for “exploring scheduling and other regulatory options under the Controlled Substances Act; including consideration of other potential avenues for prosecuting those who manufacture, import, export, sell, or distribute xylazine in order to support fentanyl trafficking.”

With no hard lines or progress updates on Federally scheduling xylazine, what’s next in terms of legislative action remains unknown. What is becoming more and more apparent is that states aren’t willing to sit around and wait. States are actionizing their rights under the 10th Amendment and taking legislative matters into their own hands so that civil and criminal penalties for individuals involved in illicit supply and distribution of xylazine can be enforced.

Kelley Detweiler is a DEA regulatory compliance expert who provides controlled-substance risk-management solutions to veterinarians through her partnership with Dr Peter Weinstein in Simple Solutions 4 Vets, Inc. Detweiler addresses controlled substance regulatory issues on a global level and has been a featured speaker at the United Nations and is the co-author of “Safeguarding Controlled Substances” published by the American Animal Hospital Association. Contact: kelley@simplesolutionsforvets.com.