Off to the Races with the xylazine state of affairs

With the 149th Kentucky Derby kicking off Triple Crown season for thoroughbreds coming on May 6, 2023, spectacular hats, iconic fashion and celebrity cameos may be on the sidelines at Churchill Downs. However, the attention is on a cocktail, but not one that’s made with bourbon, sugar and mint. This year, it’s all about the xylazine cocktail, a polydrug containing the commonly used equine sedative, xylazine, mixed with opioids like fentanyl or other controlled substances such as ketamine.

Photo: Todorean Gabriel/Adobe Stock

A dark horse

Prior to a surge in recent headlines and actions at the federal level, xylazine was, in many ways, a dark horse only recently emerging as an unknown contender for dominating illicit drug markets. Shocking both the veterinary industry and global communities at large, xylazine quickly moved from a pole position to breaking maiden as a non-human drug leading charge into a new human health crisis.

The federal pace

The federal government is notorious for moving at a slow legislative pace, in many cases, but its’ a proven “stayer” that goes the distance. Nonetheless, federal actions concerning xylazine have been moving at a surprising speed in 2023:

1. On February 28, 2023, the FDA restricted unlawful entry of xylazine into the United States, enacting authority to halt and review all xylazine shipments to verify licit purposes.¹
2. On March 20, 2023, the DEA released a Public Safety Alert concerning xylazine wherein DEA Administrator Ann Milgram declared that “xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier”.²
3. On March 28, 2023, The Combating Illicit Xylazine Act was introduced into Congress which was backed by the American Veterinary Medical Association seeking to make the manufacture, distribution, dispensing, or possession of illicit xylazine subject to Schedule III penalties under the federal Controlled Substances Act. Legitimate veterinary uses would remain under their current prescription status.³
4. On April 12, 2023, the White House Office of National Drug Control Policy named xylazine mixed with fentanyl an “emerging threat”.⁴

And they’re off!

With a myriad of unknowns concerning what will happen with xylazine at the federal level, states are off to the races, taking the reins to enact controls over xylazine.

Florida the pace setter

In 2018, Florida scheduled xylazine as a Schedule I under the Florida Controlled Substance Act⁵ due to its devastating effects on humans. As the first state to schedule xylazine Florida’s position is strong, and on March 29, 2023, Florida Attorney General Ashley Moody sent a letter to DEA Administrator Ann Milgram. In her letter, Moody refers to the DEA’s March 20, 2023, Public Safety Alert as “tardy” and urges the DEA to schedule xylazine as Florida has done. “Five years later, the [DEA] still has not taken any scheduling action Against Xylazine despite Xylazine’s abuse potential and the exponentially increasing harm that it is causing across the United States,” Moody wrote.⁶

The front runners

Ohio: On March 29, 2023, Ohio Governor Mike DeWine signed an executive order⁷ for the emergency classification of xylazine as a Schedule III controlled substance under Ohio Board of Pharmacy. To help veterinary facilities comply with Ohio Law, a temporary enforcement waiver⁸ was put in place giving Ohio veterinary clinics until June 30, 2023, to obtain a Category 3 Terminal Distributor of Dangerous Drugs license⁹, allowing continued ordering of xylazine from a licensed wholesaler. Veterinary clinics that do not obtain a terminal distributor license by June 30, 2023, will not be permitted to continue possessing and using xylazine in Ohio. Notably, only Ohio addresses xylazine use for veterinary patients.

West Virginia: Also on March 29, 2023, West Virginia Governor Jim Justice signed WV S.B. 546¹⁰ into law designating xylazine as a schedule IV-controlled substance, which will go into effect on June 8, 2023. The law places xylazine in the same category as alprazolam and diazepam.

Pennsylvania: On April 18, 2023, Pennsylvania Gov. Josh Shapiro announced that his administration will be moving forward to categorize xylazine as a Schedule III drug¹¹. This move is not surprising considering that Philadelphia has become the epicenter of the xylazine crisis in the United States.

The Stalkers

With Florida as the pacesetter and Ohio, West Virginia and now Pennsylvania following suit as front runners, additional states are also joining the running to regulate xylazine.

1. Illinois: On February 9, 2023, SB2089¹² was introduced to make xylazine a schedule I under the Illinois Controlled Substance Act with penalties for the knowing manufacture, delivery, or possession with intent to manufacture or deliver the drug. Additionally, on February 17, 2023, HB 3873¹³ was proposed to schedule xylazine as a schedule II-controlled substance.
2. Indiana: HB1286¹⁴ was introduced on January 11, 2023, for toxicology screening of xylazine in Indiana.
3. Louisiana: On March 14, 2023, HB 106¹⁵ was filed seeking to add xylazine as a Schedule II under the Louisiana Uniformed Controlled Dangerous Substances Law. As of April 10, 2023, the bill was referred to the Committee on Administration of Criminal Justice.
4. New York: In 2017, Senate Bill S7397¹⁶ sought to make xylazine a schedule III-controlled substance depressant. It was approved by the Senate but never passed in the Assembly. New York now has 2 new legislative bills in motion, SB 5439¹⁷ introduced on March 6, 2023, and AB 5914¹⁸ introduced on March 24, 2023, both of which are seeking to make xylazine a Schedule III depressant.
5. Massachusetts: Xylazine is currently classified as a schedule XI in Massachusetts according to MGL 94C Section 3¹⁹, with gabapentin and other drugs.
6. Rhode Island: HB 5922²⁰ and SB 738²¹ were introduced on March 1, 2023 seeking to designate xylazine HCL as a schedule V controlled substance.

All Bets Are Off

With the federal legislative landscape uncertain one thing is clear: no one wants xylazine to become a running mate for the opioid epidemic and states are “on the bit” for better xylazine control. Illicit use of xylazine is an escalating threat that has given our nation a challenging “Run for the Roses” of its own accord. On the brink of yet another national drug crisis we cannot afford to “spit the bit”. Betting across the board, it’s a guarantee that without action the problem will get worse.

We are far from nearing the home stretch in this race, and based on the current state of xylazine regulatory affairs it’s hard to predict how things will play out. Will states with proposed legislation withdraw and become non-runners? Will additional states join the race and propose new legislation of their own? What states will be the “also rans” and most importantly, who will be the “closer”? All bets are off, so for now, “Riders Up!”

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 has spoken on international platforms including the United Nations and is the coauthor of "Safeguarding Controlled Substances" published by American Animal Hospital Association. Contact: kelley@simplesolutionsforvets.com.

References

1. FDA takes action to restrict unlawful import of xylazine. FDA. February 28, 2023. Accessed March 10, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-restrict-unlawful-import-xylazine.
2. Public Safety Alert: DEA reports widespread threat of fentanyl mixed with xylazine. DEA. March 20, 2023. Accessed March 20, 2023. https://www.dea.gov/alert/dea-reports-widespread-threat-fentanyl-mixed-xylazine.
3. The Combatting Illicit Xylazine Use Act. United States Congress. March 28, 2023. Accessed March 28, 2023. https://www.congress.gov/bill/118th-congress/house-bill/1839/text/ih?overview=closed&format=xml.
4. Mulvihill G. White House names veterinary drug xylazine mixed with fentanyl an 'emerging threat. Time. April 12, 2023. Accessed April 12, 2023. https://time.com/6270916/xylazine-fentanyl-dangers/.
5. 2018 Florida Statutes, Title XLVI, Chapter 893, Section 03(1)(c)(37). Florida Senate. 2018. Accessed March 29, 2023. https://flsenate.gov/laws/statutes/2018/893.03.
6. Ashley Moody Attorney General. Letter RE: scheduling xylazine. Attorney General State of Florida. March 29, 2023. Accessed March 31, 2023. http://myfloridalegal.com/webfiles.nsf/WF/GPEY-CQDJSQ/$file/Xylazine+letter.pdf.
7. State of Ohio Board of Pharmacy website. Permanent Scheduling Action: placement of xylazine in Schedule III. March 29, 2023. Accessed March 30, 2023. https://www.pharmacy.ohio.gov/documents/compliance/lawenforcement/csrules/8-factor%20anlaysis%20-%20xylazine.pdf.
8. Section 4729.541: Exemption from licensure as terminal distributor of dangerous drugs. Ohio Laws & Administrative Rules. April 6, 2023. Accessed April 6, 2023. https://codes.ohio.gov/ohio-revised-code/section-4729.541.
9. ORC 4729.541[D][2]. Ohio Laws & Administrative Rules. April 6, 2023. Accessed April 7, 2023. https://codes.ohio.gov/ohio-revised-code/section-4729.541.
10. Senate Bill 546. West Virginia Legislature. March 29, 2023. Accessed April 12, 2023. http://www.wvlegislature.gov/bill_status/bills_history.cfm?INPUT=546&year=2023&sessiontype=RS.
11. Gillian McGoldrick and Ximena Conde. Pennsylvania will classify xylazine as a schedule III drug, Gov. Shapiro announces. Philadelphia Inquirer. April 18, 2023. Accessed April 18, 2023. https://www.inquirer.com/health/xylazine-schedule-iii-drug-pennsylvania-shapiro-20230418.html.
12. Sen. Patrick J. Joyce. SB2089. Illinois General Assembly. Updated March 10, 2023. Accessed March 10, 2023. https://ilga.gov/legislation/BillStatus.asp?DocTypeID=SB&DocNum=2089&GAID=17&SessionID=112&LegID=146962.
13. Rep. Jackie Haas. HB3873. Illinois General Assembly. February 17, 2023. Accessed March 8, 2023. https://www.ilga.gov/legislation/BillStatus.asp?DocNum=3873&GAID=17&DocTypeID=HB&SessionID=112&GA=103.
14. Meltzer, Lauer, Vermilion, Garcia Wilburn. HB1286. Indiana General Assembly. Updated February 14, 2023. Accessed March 8, 2023. https://in-proxy.openstates.org/2023/bills/HB1286/versions/HB1286.02.COMH.
15. L.A. H.B. 106. Louisiana State Legislature. March 17, 2023. Accessed April 13, 2023. https://www.legis.la.gov/legis/ViewDocument.aspx?d=1303169.
16. Sen. Terrence Murphy. Senate Bill S7397. New York State Senate. April 27, 2016. Accessed March 10, 2023. https://www.nysenate.gov/legislation/bills/2015/S7397.
17. Sen. James Skoufis. Senate Bill S5439. New York State Senate. March 6, 2023. Accessed March 29, 2023. https://www.nysenate.gov/legislation/bills/2023/S5439.
18. Assemblywoman Carrie Woerner. Assembly Bill A5914. New York State Senate. March 24, 2023. Accessed April 11, 2023. https://www.nysenate.gov/legislation/bills/2023/A5914.
19. Chapter 94C. Commonwealth of Massachusetts. Accessed April 6, 2023. https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXV/Chapter94C.
20. Rhode Island House Bill 5922. Rhode Island Legislature. March 1, 2023. Accessed April 3, 2023. http://webserver.rilegislature.gov/BillText/BillText23/HouseText23/H5922.pdf.
21. Rhode Island Senate Bill 738. Rhode Island Legislature. March 22, 2023. Accessed April 13, 2023. https://webserver.rilegislature.gov/BillText23/SenateText23/S0738.pdf.