Support for xylazine legislation builds in Congress

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Updated legislation pending in Congress presents a viable political pathway to help address the public health dangers of illicit xylazine while preserving the availability and current uses of this critical veterinary drug.

Supported by both the AVMA and the U.S. Drug Enforcement Administration (DEA), the updated version of the Combating Illicit Xylazine Act has bipartisan support in Congress. The DEA has even taken the unusual step of calling the bill out by name as legislation that should be signed into law. 

What the bill would do

The updated Combating Illicit Xylazine Act would equip the DEA with the necessary tools to help battle illicit xylazine by making xylazine a Schedule III drug. To protect continued veterinary access, it addresses the unintended consequences of scheduling xylazine by ensuring that the legitimate veterinary uses of this critical animal sedative would remain legal. 

The bill also includes provisions to help maintain the availability of veterinary xylazine and track the legitimate supply.

Among its provisions:

  • Xylazine would be scheduled as a Schedule III drug under the Controlled Substances Act.
  • For xylazine only, the definition of “ultimate user” under the Controlled Substances Act would be amended to protect the current legitimate uses of the drug.
  • Current manufacturers of FDA-approved xylazine would not have to make capital expenditures to facilities for the purpose of continuing to manufacture xylazine.
  • A one-year transition period would be provided to manufacturers and distributors for compliance related to labeling, packaging, and distribution logistics.
  • The DEA and U.S. Food and Drug Administration (FDA) would be required to facilitate and expedite any required manufacturer applications and submissions.
  • Veterinarians who use xylazine in their practice and aren’t already registered with the DEA would have 60 days after enactment to apply for DEA practitioner registration. They could continue their lawful activities while their application was under review.
  • Veterinarians who maintain an inventory of xylazine would have 60 days after enactment to comply with the record-keeping and inventory requirements for a Schedule III drug. 
  • The bill would require manufacturers and distributors (not veterinarians) to report product sales and movement to the DEA. 

Why this bill is needed

Without national legislation in place, xylazine restrictions are being enacted state by state. This creates a patchwork of differing rules for manufacturers and distributors to navigate, increasing the likelihood of supply disruption. Since the start of 2023, 26 states have considered xylazine legislation or regulations. Only Congress can amend the Controlled Substances Act to ensure the common uses of xylazine remain legal and include provisions to help maintain its availability and track the legitimate supply.

The updated legislation strikes the right balance between empowering law enforcement to combat illicit xylazine and maintaining veterinary access to this essential drug. While providing law enforcement tools to interdict illicit xylazine, it also includes many provisions to maintain the drug’s commercial availability for veterinary needs.

To ensure the bill’s provisions would meet the needs of veterinarians, the AVMA consulted closely with the American Association of Bovine Practitioners, the American Association of Equine Practitioners, and zoo, wildlife, and research veterinarians.

What happens next

The AVMA and other stakeholder groups are working alongside the bill’s sponsors to identify the most efficient route to get it passed. Currently, lawmakers are looking to include this legislation as part of a larger package moving through Congress.

If Congress passes the updated Combating Illicit Xylazine Act, the AVMA will work to ensure that veterinarians who use and have inventories of xylazine have the information they need to understand their obligations during the transition period.

Comments

Benjamin Pearson Jr. DVM
May 30, 2024 Permalink

Xyzaline rules done by State of Ohio since 5/12/2023

Since 5/12/2023 the state of ohio pharmacy board and Ohio dept of Health advised Govenor Dewine to impose new regulations re xylazine. I just wrote him asking for a review of this legislation after one year for a review of the # s of ohio licensed veterinarians charged with xylazine drug diversion and the # of convictions over the one year period. Also in the state of ohio we have a law that states for each new govt. regulation the law says lose two more regulations. I asked the Govenor what two regulations were removed. I know the Govenor personally so I know he will respond to my inquiry. I feel he was and still is receiving poor advice from ill informed govt. bureaucrats that impose regulations without understanding the ramifications of their actions. Example I use 20mg/ml strength xylazine in my practice, now it is available only in 100mg/ml so i need to dilute it, also we have lost more manufacturers making the drug resulting in price increases., the result is more paperwork ,more expense , more frustration and this leads to less time in our core mission of animal health. Care! I mentioned that I feel a review of arrests for involvement in diversion by vets will prove no vet involvement so what purpose did this new rule serve???

David Schmitt, DVM
January 30, 2025 Permalink

Oppose Federal Xylazine Act

Xylazine has and is regulated by FDA. Additionally requiring veterinarians who have used xylazine for the most part is by licensed veterinarians who are food animal veterinarians or equine veterinarians. Having the requirement to obtain a DEA license, which is expensive and onerous, would require additional record keeping. These veterinarians are busy as it is and this will add additional time to keep these records. Time is money. Companion animal veterinarians primarily make up the membership of the AVMA and these veterinarians have many other newer drugs and they routinely have adopted the newer drugs. Xylazine is a reliable and has been inexpensive for use food animal and equine species. If the concern is on the illegal importation of xylaxine and/or use mixed with fentanyl then I personally believe DEA should be working together with FDA - "Working Together Works". We have enough regulations currently and my fear it will be an added cost to a small group of veterinarians who rely on use of this drug. I oppose this legislation. Thank you for your consideration.

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