DEPARTMENT OF HEALTH
Temporary Scheduling of Substances; Nitazene Class of Compounds: Isotonitazene; Protonitazene; Flunitazene; Metodesnitazene; Metonitazene; Etonitazene; Butonitazene; and Etodesnitazene as Schedule I Controlled Substances
[53 Pa.B. 3033]
[Saturday, June 3, 2023]
The Acting Secretary of Health (Secretary) of the Department of Health (Department) is issuing this final order temporarily scheduling any material, compound, mixture or preparation which contains any quantity of the following Nitazene substances, their salts, isomers and salts of isomers: Isotonitazene; Protonitazene; Flunitazene; Metodesnitazene; Metonitazene; Etonitazene; Butonitazene; and Etodesnitazene (Nitazene class of compounds). These substances are not currently listed in any schedule of The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). This final order will place this group of substances in Schedule I under the act. The Secretary is taking this action because the scheduling of this Nitazene class of compounds in this Commonwealth on a temporary basis is necessary to avoid an imminent hazard to public safety.
On April 12, 2023, under section 3(d)(4) of the act (35 P.S. § 780-103(d)(4)), the Secretary transmitted to the Attorney General for review, a copy of the notice of intent to issue a final order. On April 13, 2023, the Attorney General's Office agreed in writing that the temporary scheduling of the Nitazene class of compounds as Schedule I controlled substances under the act was appropriate. The Secretary's notice of intent was published at 53 Pa.B. 2271 (April 22, 2023).
Under the act, 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 the 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 to the Attorney General.
This formal order temporarily scheduling the Nitazene class of compounds as Schedule I controlled substances is effective for 1 year from the date of publication of this final order in the Pennsylvania Bulletin. The Secretary may, during proceedings to permanently control the Nitazene class of compounds under section 3(d)(2) of the act, extend the temporary scheduling for up to 1 additional year.
The United States Drug Enforcement Administration (DEA) scheduled several Nitazenes including: Isotonitazene; Protonitazene; Flunitazene; Metodesnitazene; Metonitazene; Etonitazene; Butonitazene; and Etodesnitazene, as Schedule I controlled substances under the Federal Controlled Substance Act (CSA) (21 U.S.C.A. §§ 801—971).1 Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States and the degree of dependence the drug or other substance may cause. 21 U.S.C.A. § 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C.A. § 812(c), and the current list of all scheduled substances is published at 21 CFR Part 1308 (relating to schedules of controlled substances).
Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical supervision. 21 U.S.C.A. § 812(b)(1). The DEA determined that, because Nitazenes, including: Isotonitazene; Protonitazene; Flunitazene; Metodesnitazene; Metonitazene; Etonitazene; Butonitazene; and Etodesnitazene: (1) have high potential for abuse; (2) have no currently accepted medical use in treatment in the United States; (3) lack accepted safety for use under medical supervision; and (4) have been responsible for numerous deaths, it was, therefore, necessary to schedule these substances into Schedule I of the CSA to avoid an imminent and continued hazard to the public safety.
While scheduled Federally, the substances are not scheduled in the act. Pharmacological data suggest that this Nitazene class of compounds have potency similar to or greater than Fentanyl based on their structural modifications. Because the Nitazene class of compounds pose a substantial risk to the residents of this Commonwealth, the Secretary has determined to schedule them as Schedule I controlled substances on a temporary basis. In doing so, the Secretary is acting to protect the residents of this Commonwealth and bring the Commonwealth into conformity with Federal law.
Legal Authority and Action
Under section 3 of the act, the Secretary shall control all substances listed in Schedules I—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 (35 P.S. § 780-104), 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). As previously noted, the United States Food and Drug Administration has not approved Isotonitazene, Protonitazene, Flunitazene, Metodesnitazene, Metonitazene, Etonitazene, Butonitazene or Etodesnitazene for any type of medical use.
Because these substances are Schedule I narcotics under the CSA, the Secretary has the authority to temporarily schedule these substances under the act. Although not required to do so in taking this action, the Secretary has considered: (1) that these Nitazene class compounds are currently not approved for legitimate use in the United States; (2) that these Nitazene class compounds have potency similar to or greater than Fentanyl; (3) the availability of the Nitazene class compounds through online sites; and (4) the addictive nature of these Nitazene class compounds. Accordingly, the Secretary determined that these Nitazene class compounds are a dangerous hazard to public safety.
To revise 28 Pa. Code § 25.72 to conform to this final notice issued by the Secretary under section 3(c) of the act to temporarily schedule the Nitazene class of compounds as Schedule I controlled substances, the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.
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,
[Pa.B. Doc. No. 23-735. Filed for public inspection June 2, 2023, 9:00 a.m.]
1 Isotonitazene was permanently placed on the list of Schedule I controlled substances under the CSA in 2021. Protonitazene, Flunitazene, Metodesnitazene, Metonitazene, Etonitazene, Butonitazene and Etodesnitazene were temporarily scheduled as Schedule I controlled substances under the CSA effective December 2021, and extended through April 2024.
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