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April 19, 2023

Pennsylvania to make animal sedative xylazine a schedule III drug

Gov. Josh Shapiro said the emergence of tranq dope is 'poisoning our communities' and vowed to strengthen controls

The veterinary sedative xylazine, the drug commonly mixed with fentanyl to make "tranq dope," will be classified as a schedule III controlled substance in Pennsylvania. The drug has become a major contributor to opioid overdose deaths and was designated an "emerging threat" by the White House last week.

Acting Pennsylvania Secretary of Health Debra Bogen submitted a notice of intent to temporarily add xylazine to the list of schedule III drugs under the state's Controlled Substances Act. 

"Scheduling these drugs allows us to put tighter controls, security and record-keeping requirements in place to keep them out of our communities," Gov. Josh Shapiro said Tuesday at a press briefing in Kensington, one of the hardest hit communities in the nation's opioid epidemic. 

Pennsylvania will join a small group of other states including Ohio, Florida and West Virginia that have classified xylazine as a controlled substance under state law. By making xylazine a schedule III drug, Pennsylvania can give law enforcement the ability to prosecute those who illegally possess and sell it. 

Xylazine is FDA-approved as a veterinary drug and still will be available to animal care providers in Pennsylvania. 

The drug increasingly has been diverted from veterinary sources for use as mixing agent with fentanyl, the synthetic opioid that has led to an uptick in fatal overdoses. When taken by people, xylazine slows their breathing and heart rates and also causes severe outbreaks of skin ulcers that require medical attention to prevent infections.

The drug's interaction with fentanyl can mask the effects of the overdose reversal drug Narcan, making it difficult for first responders to interpret vital signs in life-or-death situations. In addition to dependency on opioids, people who use tranq dope also may become dependent on xylazine, which has its own set of withdrawal symptoms and recovery protocols.

In Pennsylvania, xylazine was linked as a contributor to 90 overdose deaths in 2017. That number jumped to 575 across 30 counties in 2021, an increase of more than 600% in five years, the Shapiro administration said.

Philadelphia is considered "ground zero" for the spread of xylazine in the United States during this timeframe. The drug was found in 90% of the dope samples the city tested in 2021, according to the health department, which started routinely analyzing the Philadelphia's drug supply in 2017. It was detected in more than 44% of fentanyl-involved overdose deaths and 34% of overdose deaths across all categories.

Fentanyl dealers have turned to xylazine as a way to prolong the high that users experience, since the synthetic opioid has largely replaced the longer-lasting heroin in street drugs. Fentanyl is at least 50 times more powerful than heroin, by volume, making it cheaper and easier for drug dealers to acquire.

The Biden administration took the unprecedented step last week to designate xylazine an "emerging threat," opening a 90-day period for federal officials to develop a national response plan. This will include work on xylazine testing, treatment, supportive care protocols and rapid research to better understand the drug's interaction with fentanyl. The plan also will cover the development of data systems to track the sourcing and supply of xylazine, as well as strategies to reduce the illicit use of the drug.

Xylazine is not a federally scheduled controlled substance, but could become one as a result of last week's actions. A bipartisan bill currently in the Senate aims to make it a schedule III drug.

The U.S. Drug Enforcement Agency issued a safety alert in March warning about the dangers of xylazine, noting more than 3,000 overdose deaths were linked to the sedative in 2021. Significant increases in fatalities were reported in southern and western states, where the drug has spread from the East Coast.

The FDA also restricted importation of the drug last month, hoping to limit its diversion from legitimate veterinary uses.

Philadelphia Health Commissioner Cheryl Bettigole welcomed the prospect of new federal resources in the city's effort to address the public health problems caused by tranq dope. The city is working with the Health Federation of Philadelphia and other local partners, including nonprofits, to support care for xylazine-associated wounds. The health department also has updated its overdose response trainings to incorporate the risks of xylazine

In the near future, the city plans to distribute xylazine test strips to enable better identification of what's contained in street drugs.

Last year, epidemiologists with the city's health department expressed concerns about scheduling xylazine a controlled substance, saying it could lead to black market production of synthetic versions of the drug with greater potency.

Similar problems have arisen from synthetic analogs of fentanyl, which originally was developed pharmaceutically as an intravenous anesthetic. It was made a schedule II narcotic in 1970, but in recent years, the DEA has classed several dozen "fentanyl-related substances" as schedule I controlled drugs since they have no accepted medical uses in the U.S.

Bogen also issued a notice of intent Tuesday to make nitazines, another class of synthetic opioids not approved for medical use, a schedule I drug in Pennsylvania. The notices for xylazine and nitazine will be sent to the Attorney General's Office, which will have 30 days to comment on the measures.

The acting health secretary said Tuesday that the growing threat posed by xylazine demands regulatory action in Pennsylvania alongside harm reduction. 

"Across the country and here in Pennsylvania we are seeing an alarming increase in the number of overdose deaths in which xylazine was a contributing factor," Bogen said. "Our focus remains on harm reduction strategies and helping people get treatment for substance use disorders. At the same time, we need to take action to protect people from xylazine that is increasingly found in the drug supply."

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