FDA Warning on Xylazine: Mitigating Human Risk

 | by: Sumeet Singh, Founder & Chairman | Article Posted: November 6, 2023 |

The U.S. Food and Drug Administration (FDA) has issued a warning regarding mitigating risks from human Xylazine exposure. FDA has not approved xylazine for human use and it is currently not a controlled substance under the U.S. Controlled Substances Act, nor is it approved for human-use. However, according to the Congressional Research Service, xylazine is subject to regulation by the FDA and some state laws. Since 2019, xylazine has become an adulterant in the illicit drug supply and is increasingly being detected in fatal overdoses in several cities in the United States. 

Xylazine, also known as “tranq,” is a non-opiate sedative, analgesic, and muscle relaxant only authorized in the United States for veterinary use, as approved by the FDA. Research has shown xylazine is often added to illicit opioids, including fentanyl, and people report using xylazine-containing fentanyl to lengthen its euphoric effects.  

Xylazine is a central nervous system depressant that can cause drowsiness and amnesia and slow breathing, heart rate, and blood pressure to dangerously low levels. Repeated xylazine use is also associated with skin ulcers, abscesses, and related complications.  People report using xylazine or xylazine-containing drugs by injecting, snorting, swallowing, or inhaling.  

To address the significant health challenges caused by Xylazine, several state legislatures have also introduced bills related to Xylazine. Governors have begun to implement a variety of policy solutions, ranging from bolstering drug checking initiatives to scheduling Xylazine as a controlled substance at the state level. This includes listing Xylazine as a scheduled drug and creating testing requirements for Xylazine during toxicology screenings.

Governors and legislators can classify Xylazine as a scheduled drug using authority provided to them in their state’s statutory law defining controlled substances. Although these laws generally mirror the federal Controlled Substances Act (CSA), state policy may deviate from this standard as long as the changes do not conflict with the federal policy, as defined by federal preemption standards.  Furthermore, state statutes or regulations frequently include language that provides flexibility and permits a Governor or state agency to make alterations to drug schedules in extraordinary or emergency circumstances. 

• Delaware – On June 16. 2023, Delaware Introduced SB 189 to add Xylazine to Schedule III of the Delaware Uniform Controlled Substance Act. This Act becomes effective upon the expiration of the Emergency Order issued by the Secretary of State placing Xylazine in Schedule III of the Uniform Controlled Substance Act or November 29, 2023, whichever is earlier. 

• Florida – Approved effective July 1, 2023, Xylazine to be listed as a scheduled drug under Florida Stat. 893.03 as a Schedule I substance. Citing this act as the “Prescription Drug Reform Act”; specifying additional prohibited acts related to the Florida Drug and Cosmetic Act; requiring certain drug manufacturers to notify the Department of Business and Professional Regulation of reportable drug price increases on a specified form on the effective date of such increase; requiring the Division of Consumer Services of the Department of Financial Services to designate an employee as the primary contact for consumer complaints involving pharmacy benefit managers; providing a grandfathering provision for certain pharmacy benefit managers operating as administrators; requiring pharmacy benefits plans and programs, beginning on a specified date, to annually submit a certain attestation to the Office of Insurance Regulation. 

• Illinois – On February 9, 2023, Illinois introduced SB 2089 to amend the Illinois Controlled Substance Act to add Xylazine as a Schedule I controlled substance. 

• Louisiana – On March 14,2023, Louisiana introduced HB 106 (Companion bill 645) to add Xylazine to Scheduled II of the Uniform Controlled Dangerous Substance Law. Creates the crime of unlawful production, manufacturing, distribution, or possession of Xylazine.  

• New Jersey – On May 18, 2023, New Jersey introduced AB 5488 (Companion bill 3902) as classifying Xylazine as a Schedule III Controlled Dangerous substance under certain circumstances; requires reporting of Xylazine prescriptions. 

• New York – On October 13, 2023, New York introduced AB 8130 as it relates to the classification of the drug Xylazine as a Schedule I controlled substance, and to the criminal sale and possession of Xylazine or preparations, compounds, mixtures, or substances containing xylazine. 

• Ohio – Effective September 28, 2023, Ohio Governor Mike DeWine signed an executive order directing the State Board of Pharmacy to immediately classify Xylazine as a Schedule III controlled substance.  

• Pennsylvania – On April 18, 2023, Pennsylvania Governor Josh Shapiro announced the state would be submitting a notice of intent to temporarily classify Xylazine as a Schedule III drug. On September 7, 2023, HB 1661 was introduced.  An Act amending the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, further providing for definitions and for prohibited acts and penalties; and providing for secure storage of Xylazine. 

• Tennessee – On February 1, 2023, Tennessee introduced SB 3918 (Companion bill 1242); Criminal Offenses – As enacted, makes it a Class A misdemeanor to knowingly possess Xylazine; makes it a Class C felony to knowingly manufacture, deliver, or sell xylazine, or to knowingly possess Xylazine with intent to manufacture, deliver, or sell xylazine; provides exceptions for veterinarians. – Amends TCA Title 39 and Title 40. 

• West Virginia – Effective June 10, 2023, West Virginia amended and reenact code §60A-2-210 to list Xylazine as Schedule IV of the Uniform Controlled Substance Act.  On March 29, 2023, Senate Bill 546 passed the legislature and was signed into law by West Virginia Governor Justice to classify Xylazine as a Schedule IV drug 

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