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PA Bulletin, Doc. No. 17-207

NOTICES

Temporary Scheduling of Substance: U-47700 (aka PINK) as a Schedule I Controlled Substance

[47 Pa.B. 738]
[Saturday, February 4, 2017]

 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 the synthetic opioid, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700 or PINK) as a schedule I controlled substance under The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). The Secretary is taking this action because the scheduling of this synthetic opioid 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 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 Secretary transmitted the notice to the Attorney General.

Background

 The United States Drug Enforcement Administration (DEA) temporarily scheduled this synthetic opioid as a schedule I narcotic under the Federal Controlled Substance Act (CSA) (21 U.S.C.A. §§ 801—971) effective November 14, 2016. 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, including U-47700, is published at 21 CFR Part 1308. See 21 CFR 1308.11(h)(18) (2017).

 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 such action is necessary to avoid an imminent hazard to the public safety. The United States Attorney General has delegated his scheduling authority under 21 U.S.C.A. § 811 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 of the DEA 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 U-47700: (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 U-47700 was effective on November 14, 2016, the date of publication in the Federal Register, 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.

 This synthetic opioid, however, is not currently a scheduled substance in the Commonwealth. The Commonwealth has recently seen an increase in use of U-47700 to mix with other narcotics such as heroin. The substance has a high potential for abuse and is 7.5 times stronger than morphine. It is also widely available over the internet as a ''research chemical,'' allowing for potential widespread use and abuse within the Commonwealth. Because U-47700 poses a substantial risk to the citizens of the 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 §§ 25.72and 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 U-47700 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) the increased current use of U-47700 in combination with other narcotics; (2) U-47700's addictive nature; (3) the availability of U-47700 through online distributors; and (5) the lack of a valid, medical use for U-47700. Accordingly, the Secretary determined that U-47700 is a danger 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 U-47700 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

 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 V/TT (717) 783-6514 or Pennsylvania AT&T Relay Service at (800) 654-5984.

KAREN M. MURPHY, PhD, RN, 
Secretary

[Pa.B. Doc. No. 17-207. Filed for public inspection February 3, 2017, 9:00 a.m.]


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