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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations to revolutionize gastrointestinal endoscopy because it does not cause respiratory depression. Lastly, the commenter stated that since oliceridine is not indicated for home-use, abuse of the medication by drug users would be difficult.
DEA Response: DEA notes that FDA
approved a New Drug Application NDA for oliceridine and provided DEA
with a scheduling recommendation for oliceridine. The scheduling recommendation by Health and Human Services HHS and their notification to DEA regarding the FDA approval of the NDA initiated the DEA review and scheduling action. As stated in the IFR, after careful consideration of data from preclinical and clinical studies, DEA
concurred with the HHS
recommendation that oliceridine has abuse potential comparable to other schedule II opioids and therefore supportedand continues to support through this final ruleplacement of oliceridine in schedule II under the CSA. Contrary to the commenters opinion about schedule II controls on a drug limiting its medical applications and access due to manufacturing quota requirements, DEA notes that currently several schedule II drugs oxycodone, hydrocodone etc. are extensively prescribed and used in medical practice.
Comment: One commenter stated that the chemical name provided in the interim final rule indicates oliceridine is N-3-methoxythiophen-2ylmethyl2-9R-9-pyridin-2-yl-6oxaspiro4.5decan-9-ylethylamine fumarate, though this is the name of the fumarate salt of oliceridine. The commenter noted that the other substances listed in 21 CFR 1308.12, and in most other sections of the CSA
list only the base form of the drug, and control salts by definition. The commenter suggested to provide the chemical name for oliceridine base, and the fumarate salt would be controlled under the preamble in 12 CFR 1308.12.
DEA Response: DEA agrees with commenter regarding the error in the chemical name of oliceridine and corrects appropriately by removing the word fumarate to read oliceridine as, N-3-methoxythiophen-2-ylmethyl29R-9-pyridin-2-yl-6oxaspiro4.5decan-9-ylethylamine.
The correction will make clear precisely which substance is being controlled because the fumarate salt was not the accurate designation for the controlled substance. The listing of the base form and removal of the salt designation is consistent with other controlled substance listings under the CFR and the substance designated for control remains unchanged. The base form
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listing minus the salt designation fumarate is readily understood by those registered to handle the substance and would not be misunderstood by the public. For this reason, DEA believes the change will not have an impact.
Based on the rationale set forth in the interim final rule, DEA adopts the IFR, with the above mentioned correction to the chemical name of oliceridine.
Requirements for Handling Oliceridine As indicated above, oliceridine has been a schedule II controlled substance by virtue of an IFR issued by DEA in October 2020. Thus, this final rule does not alter the regulatory requirements applicable to handlers of oliceridine that have been in place since that time.
Nonetheless, for informational purposes, we restate here those requirements. Oliceridine is subject to the CSAs schedule II regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule II substances, including the following:
1. Registration. Any person who handles manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses oliceridine, or who desires to handle oliceridine, must be registered with 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. Any person who currently handles or intends to handle oliceridine, and is not registered with DEA, must submit an application for registration and may not continue to handle oliceridine, unless DEA has approved the application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. These registration requirements, however, are not applicable to patients end users who possess oliceridine pursuant to a lawful prescription.
2. Quota. Only registered manufacturers are permitted to manufacture oliceridine in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303.
3. Disposal of stocks. Any person who does not desire or is not able to maintain a schedule II registration must surrender all quantities of currently held oliceridine, or may transfer all quantities of currently held oliceridine
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to a person registered with DEA in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
4. Security. Oliceridine is subject to schedule II security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823 and in accordance with 21 CFR 1301.71
1301.93. Non-practitioners handling oliceridine must also comply with the employee screening requirements of 21
CFR 1301.901301.93.
5. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of oliceridine must comply with 21 U.S.C. 825 and 958e and be in accordance with 21 CFR part 1302.
6. Inventory. Every DEA registrant who possesses any quantity of oliceridine must take an inventory of oliceridine on hand, pursuant to 21
U.S.C. 827 and 958e, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
Any person who becomes registered with DEA to handle oliceridine must take an initial inventory of all stocks of controlled substances containing oliceridine on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21
U.S.C. 827 and 958e, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA
registrant must take a new inventory of all stocks of controlled substances including oliceridine on hand every two years, pursuant to 21 U.S.C. 827
and 958e, and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. DEA
registrants must maintain records and submit reports for oliceridine, pursuant to 21 U.S.C. 827 and 958e, and in accordance with 21 CFR parts 1304, 1312, and 1317.
8. Orders for oliceridine. Every DEA
registrant who distributes oliceridine is required to comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
9. Prescriptions. All prescriptions for oliceridine or products containing oliceridine must comply with 21 U.S.C.
829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.
10. Manufacturing and Distributing.
In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule II controlled substances, such registrants should be advised that consistent with the foregoing considerations any manufacturing or distribution of oliceridine may only be for the
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