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PA Bulletin, Doc. No. 23-546

NOTICES

DEPARTMENT OF HEALTH

Temporary Scheduling of Substance; Xylazine as a Schedule III Controlled Substance

[53 Pa.B. 2270]
[Saturday, April 22, 2023]

 The Acting Secretary of Health (Secretary) of the Department of Health (Department) is issuing this notice of intent to issue a final notice to temporarily schedule Xylazine which is not currently listed in any schedule of The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). This temporary final notice will place Xylazine in Schedule III under the act. The Secretary is taking this action because the scheduling of Xylazine in this Commonwealth on a temporary basis is necessary to avoid an imminent hazard to public safety.

 At the time of publication in the Pennsylvania Bulletin, the Secretary will transmit a copy of the proposed notice to the Attorney General under section 3(d)(4) of the act for review (35 P.S. § 780-103(d)(4)). The Attorney General shall, by law, have 30 days from receipt of the proposed notice to provide written comments to the Department, if any.

 A formal order may not be issued before the expiration of 14 days after both:

 (i) The date of publication in the Pennsylvania Bulletin of this proposed notice of the intention to issue a final notice and the grounds upon which the order is to be issued.

 (ii) The date the Secretary transmitted the notice of intent to the Attorney General.

Background

 Although approved only for veterinary use, Xylazine is a nonopioid with an increasing presence as an adulterant, often in combination with opioids, in the illicit drug supply. Adulterants are frequently added to clandestine drugs to: (1) increase or decrease a drug's effects; or (2) increase a drug's resale value. Following these trends, the earliest reports of Xylazine indicate that it was being used to enhance the effects of heroin. Both isolated and in combination with other drugs, Xylazine is implicated as a cause or contributing cause of death in the United States. According to the United States Drug Enforcement Administration (DEA): (1) the emergence of Xylazine across the United States appears to be following the same path as Fentanyl, beginning in the Northeast before spreading to the South and then working its way into drug markets westward; and (2) its low cost contributes, in part, to Xylazine's expanded presence in the Nation's illegal drug supply.

 Xylazine use may be accompanied by skin ulcers with wounds that excrete puss, have decaying tissue and bacterial infections, which can lead to amputation at higher rates than those who inject other drugs. Heroin and Xylazine have some similar pharmacological effects including bradycardia, hypotension, central nervous system depression and respiratory depression. When used in combination with an opioid, Xylazine may worsen respiratory depression in the event of a drug overdose. Because Xylazine is not an opioid, naloxone is not known to be effective at reversing overdoses caused by Xylazine.

 Xylazine is not currently scheduled in the Commonwealth. In 2021, 30 counties across this Commonwealth saw cases where Xylazine contributed to individual deaths. In 2021, Xylazine contributed to 575 overdose deaths in the Commonwealth, a significant increase from 377 in 2020. Further, Philadelphia reported that 90% of street opioid samples in 2021 contained Xylazine. Because Xylazine poses a substantial risk to the residents of this Commonwealth, the Secretary has determined to schedule it as a Schedule III controlled substance on a temporary basis under section 4(3) of the act (35 P.S § 780-104(3)). In doing so, the Secretary is acting to protect the residents of this Commonwealth. Substances in Schedule III are those that have a potential for abuse less than those listed in Schedules I and II; a well-documented and currently accepted medical use in the United States; and abuse may lead to moderate or low physical dependence or high psychological dependence.

Legal Authority and Action

 Under section 3 of the act, the Secretary shall control all substances listed in Schedules I through V of the act. Under section 3(d) of the act, the Secretary is authorized to schedule any substance on a temporary basis to avoid an imminent hazard to public safety. When determining whether a substance poses an imminent hazard to public safety, the Secretary is required to consider: (1) the substance's history and current pattern of abuse; (2) the substance's scope, duration and significance of its abuse; (3) the risk to the public health; and (4) whether the substance is controlled under Federal law. When a substance is already controlled under Federal law, the Secretary is not required to take the remaining factors into consideration.

 In addition, the Secretary is authorized under section 3(d) of the act to schedule on a temporary basis a substance under one of the schedules in section 4 of the act, regarding schedules of controlled substances, if the substance is not listed in any other schedule in section 4 of the act or 28 Pa. Code §§ 25.72 and 25.75 (relating to schedules of controlled substances; and paregoric) and if no exception or approval is in effect for the substance under section 505 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. § 355).

 In taking this action, the Secretary has considered: (1) that Xylazine has a documented, acceptable and important use in veterinary medicine; however, it currently is not approved for legitimate use by humans in the United States; (2) that Xylazine, both isolated and in combination with other drugs, is a cause or contributing cause of an increasing number of deaths in this Commonwealth; (3) the rise of Xylazine as one of the most common adulterants in the drug supply; and (4) Naloxone and other reversal agents' lack of effectiveness in the event of an overdose involving Xylazine. Accordingly, although not currently scheduled at the Federal level, the Secretary has determined that Xylazine is a dangerous hazard to public safety in this Commonwealth.

 To revise 28 Pa. Code § 25.72 to conform to any final notice issued by the Secretary under section 3(c) of the act to temporarily schedule Xylazine as a Schedule III controlled substance, the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final-form rulemaking with proposed rulemaking omitted.

Accessibility

 For additional information, or persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the Department of Health, Melissa Myers, Policy Office, 625 Forster Street, 8th Floor, Health and Welfare Building, Harrisburg, PA 17120, (717) 547-3104, or for speech and/or hearing impaired persons, call the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).

DR. DEBRA L. BOGEN, 
Acting Secretary

[Pa.B. Doc. No. 23-546. Filed for public inspection April 21, 2023, 9:00 a.m.]


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