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PA Bulletin, Doc. No. 18-302

NOTICES

DEPARTMENT OF HEALTH

Temporary Scheduling of Substance; Fentanyl-Related Substances as a Schedule I Controlled Substance

[48 Pa.B. 1237]
[Saturday, February 24, 2018]

 The Acting Secretary of Health (Acting Secretary) of the Department of Health (Department) is issuing this notice of intent to issue a final notice to temporarily schedule fentanyl-related substances that 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 temporary final notice will place these substances in schedule I under the act. The Acting Secretary is taking this action because the scheduling of fentanyl-related substances 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 Acting 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 his 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 Acting Secretary transmitted the notice to the Attorney General.

Background

 The United States Drug Enforcement Administration (DEA) published its intent to classify fentanyl-related substances as schedule I synthetic opioids under the Federal Controlled Substances Act (CSA) (21 U.S.C.A. §§ 801—971) at 82 FR 61700 (December 29, 2017). The DEA's temporary scheduling order was issued upon its publication at 83 FR 5188 (February 6, 2018) and is effective February 6, 2018, until February 6, 2020. If the order is extended or made permanent, the DEA will publish a document in the Federal Register.

 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 he finds that the action is necessary to avoid an imminent hazard to the public safety. The United States Attorney General has delegated his 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. Section 201(h)(3) of the CSA.

 The Administrator of the DEA determined that because fentanyl-related substances have: (1) a high potential for abuse; (2) no currently accepted medical use in treatment in the United States; and (3) a lack of accepted safety for use under medical supervision, it was necessary to temporarily schedule I of the CSA to avoid an imminent hazard to the public safety. 83 FR 5188, 5190 (February 6, 2018). A substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA (21 U.S.C.A. § 812), or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.A. § 355). If an exemption or approval is in effect under section 505 of the FD&C Act with respect to a substance that falls within the definition of a fentanyl-related substance set forth in this notice and the final notice, the substance will be excluded from the temporary scheduling order.

 The DEA has further determined that its current temporary scheduling notice would define fentanyl-related substances to include any substance that is structurally related to fentanyl by one or more of the following modifications:

 1. Replacement of the phenyl portion of the phenethyl groups by any monocycle, whether further substituted in or on the monocycle.

 2. Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, halo, haloalkyl, amino or nitro groups.

 3. Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, haloalkyl, amino or nitro groups.

 4. Replacement of the aniline ring with an aromatic monocycle whether further substituted in or on the aromatic monocycle.

 5. Replacement of the N-propionyl group by another acyl group.

 83 FR 5188, 5191 and 5192. The DEA's temporary scheduling order includes all substances that fall within the previous definition—even if the substances have not yet emerged on the illicit market in the United States or this Commonwealth. The DEA further noted in its temporary scheduling order that none of the substances being temporarily controlled has a currently accepted medical use in treatment in the United States.

 In this Commonwealth, fentanyl-related substances are not currently scheduled. The Commonwealth has recently seen an increase in use of the drug to mix with heroin and other substances (such as cocaine and methamphetamine) or used in counterfeit pharmaceutical prescription drugs. Consequently, users who buy these substances on the illicit market are often unaware of the specific substance they are actually consuming and the associated risk with that substance. Fentanyl-related substances have a high potential for abuse and are approximately 100 times stronger than morphine. Typically, these substances are manufactured outside the United States by clandestine manufacturers and then smuggled into the United States. They are also widely available over the internet as a ''research chemical,'' allowing for potential widespread use within this Commonwealth.

 These factors, in addition to fentanyl-related substances not currently listed in any schedule having no currently acceptable medical use in the United States, show that fentanyl-related substances pose a substantial risk to the public. This has prompted the Acting Secretary to schedule fentanyl-related substances as schedule I controlled substances on a temporary basis. In doing so, the Acting 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 Acting Secretary shall control all substances listed in schedules I through V of the act. Under section 3(d) of the act, the Acting 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 Acting 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 Acting Secretary is not required to take the remaining factors into consideration.

 In addition, the Acting 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 FD&C Act. As previously noted, the FDA has not approved fentanyl-related substances not currently listed in any schedule under the CSA for any type of medical use.

 Because fentanyl-related substances are not currently listed in any schedule of the CSA, the Acting Secretary has the authority to temporarily schedule fentanyl-related substances under the act. Although not required to do so in taking this action, the Acting Secretary has considered: (1) the increased current use of fentanyl-related substances in combination with other substances; (2) fentanyl-related substances' addictive nature; (3) the fact that fentanyl-related substances are approximately 100 times more potent than morphine; (4) the availability of fentanyl-related substances through online distributors; and (5) the lack of a valid, medical use. Accordingly, the Acting Secretary determined that fentanyl-related substances are a dangerous hazard to public safety.

 To revise 28 Pa. Code § 25.72 to conform to any final notice issued by the Acting Secretary under section 3(c) of the act to temporarily schedule as schedule I controlled substances fentanyl-related substances that are not currently listed in any schedule under the act, the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.

Accessibility

 Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the Department of Health, Bureau of Community Program Licensure and Certification, Division of Home Health, Drug, Device and Cosmetic Program, 132A Kline Plaza, Harrisburg, PA 17104, (717) 783-1379, 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, 
Acting Secretary

[Pa.B. Doc. No. 18-302. Filed for public inspection February 23, 2018, 9:00 a.m.]


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