Innovations-Magazine-NovDec-2023 - 8

[Xylazine's] inclusion in illicit opioids
poses significant health risks,
complicating overdose identification
and treatment.
In spring 2023, Congress introduced the Combating
Illicit Xylazine Act (S 993/HR 1839). The proposed bill
would make xylazine subject to regulation as a Schedule III
substance under the CSA. Illicit use would include any use
or intended use in people and would address any diversion
of xylazine from veterinary sources. Veterinary uses would
remain under their current prescription status. Statements of
support for the legislation were announced by organizations
such as the National Association of Attorneys General
and the American Veterinary Medical Association.
Other organizations, such as the National Harm Reduction
Coalition, have stated that the bill would be a move in the
wrong direction by further criminalizing people who use
drugs. " Drug users are not seeking xylazine. It's often mixed
into drugs that they're taking, " the director of overdose
prevention policy at the organization told CNN. " So we have
concerns that we'd be punishing drug users for a substance
that they may not even know is found in their drug. "
At press time, the Combating Illicit Xylazine Act had been
referred to committees in both the House of Representatives
and the Senate.
Meanwhile, several federal agencies have also taken actions
intended to restrict or regulate the proliferation of illicit xylazine.
In November 2022, FDA published an alert for health care
providers on the risks to patients exposed to xylazine in illicit
drugs. In February 2023, FDA announced further action taken
to restrict the unlawful entry of xylazine into the country.
" The FDA remains concerned about the increasing prevalence
of xylazine mixed with illicit drugs, and this action is one part of
broader efforts the agency is undertaking to address this issue, "
said FDA Commissioner Robert M. Califf, MD, in an FDA
press release. " We will continue to use all tools at our disposal
and partner with the Drug Enforcement Administration and
other federal, state, local agencies and stakeholders as appropriate
to stem these illicit activities and protect public health. "
In July, three months after declaring fentanyl combined with
xylazine as an " emerging threat, " the White House Office of
National Drug Control Policy released the " Fentanyl Adulterated
or Associated with Xylazine Response Plan, " which outlined
6 | NOV/DEC 2023
action steps the federal government would pursue to address the
challenges of xylazine and its impact on the opioid crisis. These
steps include improving standardized forensic testing to better
estimate use and exposure to xylazine alone or in combination with
other drugs, increasing access to evidence-based prevention and
harm reduction strategies, and identifying the sources of the illicit
xylazine. The plan also included a goal to reduce xylazine-positive
drug poisoning deaths by 15% by 2025 (compared to 2022).
In addition, FDA has issued an alert for US Customs and
Border Protection (CBP) to detain shipments of xylazine that
appear to be adulterated or misbranded. Further, FDA's Center
for Veterinary Medicine and CBP are working to identify xylazine
shipments that are packaged and declared other products.
At the state level, several governors have taken independent
action to address xylazine regulation. A 2018 law in Florida
requires that xylazine be treated as a Schedule I substance,
making it illegal to possess or sell it in the state for any reason.
Since xylazine combined with fentanyl began gaining national
attention, several other states have taken temporary or emergency
actions to similarly regulate the drug, though not as strictly.
For example, in May 2023, the governor of Ohio signed an executive
order directing the state's board of pharmacy to " immediately
classify xylazine as a Schedule III controlled substance. "
Since then, several other states have taken similar actions,
including Pennsylvania and Delaware (Schedule III), as well as
West Virginia (Schedule IV).
Xylazine has emerged as a pressing concern in the context
of the ongoing opioid crisis in the US. Its inclusion in illicit
opioids poses significant health risks, complicating overdose
identification and treatment. Regulatory efforts at the federal and
state levels are underway, aiming to address this issue from various
angles. While these measures hold promise, they also warrant
careful consideration of potential unintended consequences,
particularly in the context of harm reduction strategies. As
the opioid crisis evolves, NABP will continue to monitor and
report on trends and regulatory efforts to mitigate harm.

Innovations-Magazine-NovDec-2023

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