Source: https://www.deadiversion.usdoj.gov/fed_regs/rules/2017/fr1026_5.htm
Timestamp: 2018-02-24 02:31:09
Document Index: 457857100

Matched Legal Cases: ['arts 1301', 'arts 1301', 'art 1302', 'arts 1304', 'arts 1304', 'art 1305', 'art 1312', 'art 1303']

2017 - Temporary Amendment; Temporary Scheduling Order: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
RESOURCES > Federal Register Notices > Rules - 2017 > Temporary Amendment; Temporary Scheduling Order: Temporary Placement of ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
[Pages 49504-49508]
[FR Doc No: 2017-23206]
[Docket No. DEA-473]
SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.
DATES: This temporary scheduling order is effective October 26, 2017, until October 28, 2019. If this order is extended or made permanent, the DEA will publish a document in the Federal Register.
Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into Schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling \1\ for up to one year. 21 U.S.C. 811(h)(2).
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.\2\ The Administrator transmitted notice of his intent to place ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in Schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter. Notice for these actions was transmitted on the following dates: May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl). The Assistant Secretary responded by letters dated June 9, 2017 (ortho-fluorofentanyl) and July 14, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for ortho-
[[Page 49505]]
fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl into Schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in Schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to issue a temporary order to schedule ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl was published in the Federal Register on September 12, 2017. 82 FR 42754.
Available data and information for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, summarized below, indicate that these synthetic opioids 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. The DEA's three-factor analysis, and the Assistant Secretary's June 9, 2017 and July 14, 2017 letters are available in their entirety under the tab "Supporting Documents" of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2017-0005 (Docket Number DEA-473).
The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have recently been encountered by law enforcement and public health officials. Adverse health effects and outcomes are demonstrated by fatal overdose cases involving these substances. The documented adverse health effects of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are consistent with those of other opioids.
On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on June 19, 2017. STARLiMS registered four reports containing ortho-fluorofentanyl from California and five reports containing tetrahydrofuranyl fentanyl from Florida and Missouri. According to STARLiMS, the first laboratory submissions of ortho-fluorofentanyl and tetrahydrofuranyl fentanyl occurred in April 2016, and March 2017, respectively.
The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state, and local forensic laboratories across the country. Data from NFLIS was queried on June 20, 2017. NFLIS registered three reports containing ortho-fluorofentanyl from state or local forensic laboratories in Virginia.\3\ According to NFLIS, the first report of ortho-fluorofentanyl was reported in September 2016. NFLIS registered two reports containing tetrahydrofuranyl fentanyl from state or local forensic laboratories in New Jersey and was first reported in January 2017. The identification of methoxyacetyl fentanyl in drug evidence submitted in April 2017 was reported to DEA from a local laboratory in Ohio.\4\ The DEA is not aware of any laboratory identifications of ortho-fluorofentanyl prior to 2016 or identifications of tetrahydrofuranyl fentanyl or methoxyacetyl fentanyl prior to 2017.
\3\ Data are still being collected for March 2017-June 2017 due to the normal lag period for labs reporting to NFLIS.
\4\ Email from Cuyahoga County Medical Examiner's Office, to DEA (May 8, 2017 02:29 p.m. EST) (on file with DEA).
Evidence suggests that the pattern of abuse of fentanyl analogues, including ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been encountered in powder form similar to fentanyl and heroin and have been connected to fatal overdoses.
Reports collected by the DEA demonstrate ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are being abused for their opioid properties. Abuse of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have resulted in mortality (see DEA 3-Factor Analysis for full discussion). The DEA collected post-mortem toxicology and medical examiner reports on 13 confirmed fatalities associated with ortho-fluorofentanyl which occurred in Georgia (1), North Carolina (11), and Texas (1), two confirmed fatalities associated with tetrahydrofuranyl fentanyl which occurred in New Jersey (1) and Wisconsin (1), and two confirmed fatalities associated with methoxyacetyl fentanyl which occurred in Pennsylvania. It is likely that the prevalence of these substances in opioid related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate fentanyl analogues from fentanyl.
ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been identified in drug evidence collected by law enforcement. NFLIS and STARLiMS have a total of seven drug reports in which ortho-fluorofentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 from law enforcement encounters in California and Virginia and seven drug reports in which tetrahydrofuranyl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2017 from law
[[Page 49506]]
enforcement encounters in Florida, Missouri, and New Jersey. The identification of methoxyacetyl fentanyl in drug evidence submitted in April 2017 was reported to DEA from Ohio.
The population likely to abuse ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl, and other fentanyl-related substances. This is evidenced by the routes of drug administration and drug use history documented in ortho-fluorofentanyl and tetrahydrofuranyl fentanyl fatal overdose cases. Because abusers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are likely to obtain these substances through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e. use a drug for the first time) ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.).
ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl exhibit pharmacological profiles similar to that of fentanyl and other [micro]-opioid receptor agonists. The toxic effects of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in humans are demonstrated by overdose fatalities involving these substances. Abusers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl may not know the origin, identity, or purity of these substances, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.
Based on information received by the DEA, the misuse and abuse of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl lead to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are high. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.
ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have been associated with numerous fatalities. At least 13 confirmed overdose deaths involving ortho-fluorofentanyl abuse have been reported from Georgia (1), North Carolina (11), and Texas (1). At least two confirmed overdose deaths involving tetrahydrofuranyl fentanyl have been reported from New Jersey (1) and Wisconsin (1). At least two confirmed overdose deaths involving methoxyacetyl fentanyl have been repored from Pennsylvania. As the data demonstrate, the potential for fatal and non-fatal overdoses exists for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl and these substances pose an imminent hazard to the public safety.
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl fentanyl in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in Schedule I. 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. Available data and information for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl indicate that these substances 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. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through letters dated May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), notified the Assistant Secretary of the DEA's intention to temporarily place these substances in Schedule I. A notice of intent was subsequently published in the Federal Register on September 12, 2017. 82 FR 42754.
In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I of the CSA, and finds that placement of these synthetic opioids into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety.
Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl is effective on the date of publication in the Federal Register, and is in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
Upon the effective date of this temporary order, ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of Schedule I controlled substances including the following:
1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of October 26, 2017. Any person who currently handles ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl as of October 26, 2017, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of Schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of these substances in a manner not authorized by the CSA on or after October 26, 2017 is unlawful and those in possession of any quantity of these substances may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is not able to obtain a Schedule I registration to handle ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, must surrender all quantities of currently held ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.
3. Security. ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are subject to Schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of October 26, 2017.
4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from October 26, 2017, to comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl on the effective date of this order must take an inventory of all stocks of these substances on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect to ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and Sec. 1307.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.
7. Reports. All DEA registrants who manufacture or distribute ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of October 26, 2017.
8. Order Forms. All DEA registrants who distribute ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of October 26, 2017.
9. Importation and Exportation. All importation and exportation of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of October 26, 2017.
10. Quota. Only DEA registered manufacturers may manufacture ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of October 26, 2017.
11. Liability. Any activity involving ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl not authorized by, or in violation of the CSA, occurring as of October 26, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.
As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, "any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines." 5 U.S.C. 808(2). It is in the public interest to schedule these substances immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place these substances into Schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule.
2. In Sec. 1308.11, add reserved paragraphs (h)(15) through (18) and paragraphs (h)(19), (20), and (21) to read as follows:
[FR Doc. 2017-23206 Filed 10-25-17; 8:45 am]