NOTICES
DEPARTMENT OF HEALTH
Temporary Scheduling of Substance; Isotonitazene as a Schedule I Controlled Substance
[50 Pa.B. 4616]
[Saturday, September 5, 2020]The Secretary of Health (Secretary) of the Department of Health (Department) is issuing this notice of intent to issue a final notice to temporarily schedule Isotonitazene, 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 this substance in Schedule I under the act. The Secretary is taking this action because the scheduling of Isotonitazene 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 (35 P.S. § 780-103(d)(4)) for review. The Attorney General shall, by law, have 30 days from receipt of the proposed notice to provide written comments to the Department, if any.
Any 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
The United States Drug Enforcement Administration (DEA) temporarily scheduled Isotonitazene as a Schedule I narcotic under the Federal Controlled Substance Act (CSA) (21 U.S.C.A. §§ 801—971) on August 20, 2020. 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).
Section 201 of the CSA (21 U.S.C.A. § 811) provides the United States Attorney General with the authority to temporarily place a substance in Schedule I of the CSA for 2 years if they find that the action is necessary to avoid an imminent hazard to the public safety. The Attorney General has delegated scheduling authority under section 201 of the CSA to the Administrator of the DEA. To find that placing a substance temporarily into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider: (1) the substances' history and current pattern of abuse; (2) the scope, duration and significant of abuse; and (3) what, if any, risk there is to the public health. 21 U.S.C.A. § 811(h)(3).
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 Administrator for the DEA determined that, because Isotonitazene: (1) has a high potential for abuse; (2) has no currently accepted medical use in treatment in the United States; and (3) lacks accepted safety for use under medical supervision, it was necessary to temporarily schedule the substance into Schedule I of the CSA to avoid an imminent hazard to the public safety. The final order temporarily scheduling Isotonitazene was effective on August 20, 2020, and will be in effect for a period of 2 years, with a possible extension of 1 additional year, pending completion of the regular (permanent) scheduling process.
However, Isotonitazene is not currently a scheduled substance in this Commonwealth. In the United States, Isotonitazene is considered one of the most persistent and prevalent new opioids. Isotonitazene has been identified in at least 18 deaths in the United States that occurred between August 2019 and January 2020. Pharmacological data suggest that the group of synthetic opioids that includes Isotonitazene (along with Etonitazene, Metonitazene and Clonitazene) has potency similar to or greater than fentanyl based on their structural modifications. Because Isotonitazene poses a substantial risk to the citizens of this Commonwealth, the Secretary has determined to schedule it as a Schedule I controlled substance on a temporary basis. In doing so, the Secretary is acting to protect the citizens 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 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 (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 for any type of medical use.
Because this substance is a Schedule I narcotic under the CSA, the Secretary has the authority to temporarily schedule this substance under the act. Although not required to do so in taking this action, the Secretary has considered: (1) that Isotonitazene currently is not approved for legitimate use in the United States; (2) that Isotonitazene has potency similar to or greater than fentanyl; (3) the availability of Istonitazene through online distributors; and (4) the addictive nature of Isotonitazene. Accordingly, the Secretary determined that Isotonitazene is a dangerous hazard to public safety.
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 Isotonitazene as a Schedule I controlled substance, the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final 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, Lori Gutierrez, MPA, Deputy Director, Policy Office, 625 Forester Street, 8th Floor, Health and Welfare Building, Harrisburg, PA 17120, (717) 317-5426, or for speech and/or hearing impaired persons, call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
RACHEL L. LEVINE, MD,
Secretary
[Pa.B. Doc. No. 20-1225. Filed for public inspection September 4, 2020, 9:00 a.m.]
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