87 FR 14 pgs. 3335-3340 - Exempt Chemical Preparations Under the Controlled Substances Act
Type: NOTICEVolume: 87Number: 14Pages: 3335 - 3340
Pages: 3335, 3336, 3337Docket number: [Docket No. DEA-372]
FR document: [FR Doc. 2022-01125 Filed 1-20-22; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-372]
Exempt Chemical Preparations Under the Controlled Substances Act
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Order with opportunity for comment.
SUMMARY:
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 1, 2021, and June 30, 2021, as listed below, were accepted for filing and have been approved or denied as indicated.
DATES:
Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). Electronic comments must be submitted, and written comments must be postmarked, on or before March 22, 2022. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
ADDRESSES:
To ensure proper handling of comments, please reference "Docket No. DEA-372" on all correspondence, including any attachments.
Electronic comments: Drug Enforcement Administration encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a comment tracking number, your comment has been successfully submitted and there is no need to resubmit the same comment.
Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Ph.D., Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-8201.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received.
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.
An electronic copy of this document is available at http://www.regulations.gov for easy reference.
Legal Authority
Section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain compounds, mixtures, or preparations containing a controlled substance, if he finds that such compounds, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B). 1 The Drug Enforcement Administration (DEA) regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Assistant Administrator may exempt a chemical preparation or mixture from certain provisions of the CSA. The Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time.
Footnotes:
1 ?This authority has been delegated from the Attorney General to the DEA Administrator by 28 CFR 0.100, and subsequently redelegated to the Deputy Assistant Administrator pursuant to 28 CFR 0.104 and Section 7 of the appendix to subpart R of part 0.
Exempt Chemical Preparation Applications Submitted Between April 1, 2021, and June 30, 2021
[top] The Assistant Administrator received applications between April 1, 2021, and June 30, 2021, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. Pursuant to the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart I below is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or animal and either: (1) Contains no narcotic controlled substance and is packaged in such a form or concentration that the packaged quantity does not present any significant potential for abuse; or (2) contains either a narcotic or non-narcotic controlled substance and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion, or concentration that the preparation or mixture does not present any potential for abuse and, if the preparation or mixture contains a narcotic controlled substance, is formulated in such a manner that it incorporates methods of denaturing or other means so that the preparation or
Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), 21 CFR 1308.23, and 21 CFR 1308.24, the Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by DEA is exempt, to the extent described in 21 CFR 1308.24, from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the date that was provided in the approval letters to the individual requesters.
Scope of Approval
The exemptions are applicable only to the precise preparation or mixture described in the application submitted to DEA in the form(s) listed in this order and only for those above mentioned sections of the CSA and the CFR. In accordance with 21 CFR 1308.24(h), any change in the quantitative or qualitative composition of the preparation or mixture, or change in the trade name or other designation of the preparation or mixture after the date of application requires a new application. The requirements set forth in 21 CFR 1308.24(b)-(e) apply to the exempted materials. In accordance with 21 CFR 1308.24(g), DEA may prescribe requirements other than those set forth in 21 CFR 1308.24(b)-(e) on a case-by-case basis for materials exempted in bulk quantities. Accordingly, in order to limit opportunity for diversion from the larger bulk quantities, DEA has determined that each of the exempted bulk products listed in this order may only be used in-house by the manufacturer, and may not be distributed for any purpose, or transported to other facilities.
Additional exempt chemical preparation requests received between April 1, 2021, and June 30, 2021, and not otherwise referenced in this order, may remain under consideration until DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. DEA's order on such requests will be communicated to the public in a future Federal Register publication.
DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR 1308.24(a). All other requirements of the CSA and the CFR apply, including registration as an importer as required by 21 U.S.C. 957.
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| Supplier | Product name | Form | Application date |
|---|---|---|---|
| Aalto Scientific, Ltd | Immunoassay Base (Level A-E) | Glass or plastic bottle or flask: 500 mL-1 L | 4/13/2021 |
| Aalto Scientific, Ltd | Immunoassay Base (Level A-E) | Glass or plastic bottle or flask: 100 mL-500 mL | 4/13/2021 |
| Aalto Scientific, Ltd | Immunoassay Base (Level A-E) | Glass or plastic bottle or flask: 1 mL-100 mL | 4/13/2021 |
| Aalto Scientific, Ltd | Immunoassy Base (Level A-E) | Glass vial, bottle, or flask: 1 mL | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Base (Level A-E) | Glass vial, bottle, or flask: 500 mL-1L | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Base (Level A-E) | Glass vial, bottle, or flask: 100mL-500 mL | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Base (Level A-E) | Glass vial, bottle, or flask: 1 mL-100 mL | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Beckman AU Base (Level A-E) | Glass vial, bottle, or flask: 500 mL-1L | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Beckman AU Base (Level A-E) | Glass vial, bottle, or flask: 100mL-500 mL | 4/1/2021 |
| Aalto Scientific, Ltd | TDM Beckman AU Base (Level A-E) | Glass vial, bottle, or flask: 1 mL-100 mL | 4/1/2021 |
| ARK Diagnostics, Inc | DRI Fentanyl II Control | Kit: 4 Dropper vials, 10 mL each | 4/15/2021 |
| ARK Diagnostics, Inc | DRI Fentanyl II Cutoff Calibrator | Kit: 2 Dropper vials, 10 mL each | 4/15/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur | Kit: 5 vials; 3 mL each | 4/29/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level A | Glass vial: 3 mL | 4/29/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level B | Glass vial: 3 mL | 4/29/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level C | Glass vial: 3 mL | 4/29/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level D | Glass vial: 3 mL | 4/29/2021 |
| Audit MicroControls | Linearity FD Fertility Siemens Atellica/Centaur, Set 2 Level E | Glass vial: 3 mL | 4/29/2021 |
| Audit MicroControls | Linearity FD TDM Siemens Atellica/Centaur | Kit: 5 vials; 5 mL each | 4/27/2021 |
| Cayman Chemical Company | (S)-5-fluoro ADB (CRM); 100 µg/mL in Acetonitrile | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 2'-fluoro ortho-Fluorofentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-ANPP (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-ANPP (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-ANPP-13C6 (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-ANPP-d5 (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-ANPP-d5 (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4'-chloro-a-Pyrrolidinovalerophenone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-cyano CUMYL-BUTINACA (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4'-methyl Acetyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4'-methyl Acetyl fentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4-methyl-a-Ethylaminopentiophenone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 4'-methyl-a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | 5-fluoro CUMYL-PINACA; 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Acrylfentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Acrylfentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Butyryl fentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cocaethylene (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cyclohexyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cyclohexyl fentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cyclopentyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cyclopropyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Cyclopropyl fentanyl-13C6 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | D8-THCA-A (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D8-THCA-A (CRM) 100 µg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D8-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D8-THCH (CRM) 1 mg/ml, 1 mL in methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D8-THCH (CRM) 100 µg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D8-THCH (CRM) 100 µg/ml, 1 mL in methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCB (CRM) 100 µg/mL, 1 mL acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCB (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCB (CRM) 1 mg/ml, 1 mL methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCB (CRM) 100 µg/mL, 1 mL methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCBA-A (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCBA-A (CRM) 100 µg/mL, 1 mL acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCH (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCH (CRM) 1 mg/ml, 1 mL in methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCH (CRM) 100 µg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCH (CRM) 100 µg/ml, 1 mL in methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCHA-A (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCHA-A (CRM) 100 µg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCP (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCP (CRM) 1 mg/ml, 1 mL methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCP (CRM) 100 µg/mL, 1 mL acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCP (CRM) 100 µg/mL, 1 mL methanol | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCPA-A (CRM) 1 mg/ml, 1 mL in acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | D9-THCPA-A (CRM) 100 µg/mL, 1 mL acetonitrile | Glass ampule: 1 mL | 6/8/2021 |
| Cayman Chemical Company | FIBF (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | FIBF-d7 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Furanyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Furanyl fentanyl-13C6 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Furanyl fentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Isobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Isobutyryl fentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Lorcaserin (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | meta-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | meta-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Methoxyacetyl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | MMB-FUBINACA (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | MT-45-d11 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | N-ethyl Pentylone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Ocfentanil (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Ocfentanil-d5 (hydrochloride); 100 µg/mL in Methanol (CRM) | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | ortho-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | ortho-Fluoroisobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-Chloroisobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-Fluorobutyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-Fluorobutyryl fentanyl-13C6 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-Fluorobutyryl fentanyl-d7 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-Fluorofentanyl-d5 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-methoxy-Butyryl fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | para-methoxy-Butyryl fentanyl-d7 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | PV8 (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Tetrahydrofuran fentanyl (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Valeryl fentanyl (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Valeryl fentanyl-13C6 (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | Valeryl fentanyl-d5 (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | a-Ethylaminohexanophenone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cayman Chemical Company | a-Pyrrolidinohexanophenone (hydrochloride) (CRM); 100 µg/mL in Methanol | Glass ampule: 1.0 mL | 4/14/2021 |
| Cerilliant Corporation | 6-Acetylcodeine-D3 | Glass ampule: 1.0 mL | 4/15/2021 |
| Cerilliant Corporation | Normorphine-D3 | Glass ampule: 1.0 mL | 4/15/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 1, Part: 43746 | Bottle: 500 ml | 4/27/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 1, Part: 83737 | Vial: 5 ml | 4/27/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 2, Part: 43747 | Bottle: 500 ml | 4/27/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 2, Part: 83738 | Vial: 5 ml | 4/27/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 3, Part: 43747 | Bottle: 500 ml | 4/27/2021 |
| Cliniqa Corporation | TDM + MTX Control Level 3, Part: 83739 | Vial: 5 ml | 4/27/2021 |
| College of American Pathologists | 2022 DMPM-01 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 DMPM-02 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 DMPM-03 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 DMPM-05 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 DMPM-06 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 DMPM-07 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-02 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-03 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-04 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-05 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-07 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-08 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-10 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-12 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-13 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 FTC-14 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-01 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-02 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-03 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-04 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-05 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-06 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-07 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-08 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-10 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-11 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-12 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-13 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-14 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-15 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-16 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-17 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-18 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-19 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 OFD-20 | HDPE vial: 2 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-03 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-04 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-05 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-07 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-08 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-09 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-12 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 T-13 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-01 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-02 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-03 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-04 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-05 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 THCB-06 | Glass vial: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-01 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-02 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-03 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-04 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-05 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-06 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-07 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-08 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-09 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-10 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-11 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-12 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-13 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-14 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UDS-15 | HDPE bottle: 10 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-01 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-02 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-03 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-04 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-05 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-06 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-07 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-08 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-09 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-10 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-11 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-12 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-13 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-14 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UT-15 | HDPE bottle: 50 mL | 4/19/2021 |
| College of American Pathologists | 2022 UTCO-01 | HDPE bottle: 40 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-01 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-02 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-03 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-04 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-05 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022 ZE-06 | Glass vial: 5 mL | 4/19/2021 |
| College of American Pathologists | 2022FTC-01 | HDPE bottle: 20 mL | 4/19/2021 |
| College of American Pathologists | 2022-OFD-09 | HDPE vial: 2 mL | 4/19/2021 |
| CPI International | (-)-delta9-tetrahydrocannabinol (d9-THC) 1000 mg/L, 1 mL | Amber ampule: 1 mL | 4/7/2021 |
| LGC-Dr. Ehrenstorfer | Custom (-)-delta9-tetrahydrocannabinol (d9-HC) 1000 µg/mL in acetonitrile | Amber ampule: 1 mL | 4/12/2021 |
| LGC-Dr. Ehrenstorfer | Custom Pharmaceutical Mix 6509 100-10000 µg/mL in methanol | Amber ampule: 1 mL | 6/8/2021 |
| LGC-Dr. Ehrenstorfer | Custom Pharmaceutical Mix 6509 100-10000 µg/mL in methanol | 1 kit: 5 ampules × 1 mL each | 4/12/2021 |
| LGC-Dr. Ehrenstorfer | ?11-Tetrahydrocannabinol (?11-THC) 100 µg/mL in Methanol | Amber ampule: 1 mL | 6/14/2021 |
| LGC-Dr. Ehrenstorfer | ?11-Tetrahydrocannabinol (?11-THC) 100 µg/mL in Methanol | Amber ampule: 1 mL | 4/20/2021 |
| LGC-Dr. Ehrenstorfer | ?11-Tetrahydrocannabinol (?11-THC) 1000 µg/mL in Methanol | Amber ampule: 1 mL | 6/14/2021 |
| LGC-Dr. Ehrenstorfer | ?11-Tetrahydrocannabinol (?11-THC) 1000 µg/mL in Methanol | Amber ampule: 1 mL | 4/20/2021 |
| LGC-Dr. Ehrenstorfer | ?9-Tetrahydrocannabivarinic acid (THCVA) 100 µg/mL in Methanol | Amber ampule: 1 mL | 6/8/2021 |
| LGC-Dr. Ehrenstorfer | ?9-Tetrahydrocannabivarinic acid (THCVA) 1000 µg/mL in Methanol | Amber ampule: 1 mL | 6/8/2021 |
| LGC-Dr. Ehrenstorfer | Boldenone cypionate 100 µg/mL in Acetonitrile | Amber ampule: 1 mL | 5/4/2021 |
| Lin-Zhi International | LZI Norfentanyl (Q) Qualitative Calibrator (5 ng/mL), Ref# C68815 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | LZI Norfentanyl Level 1 Control (3.75 ng/mL), Ref# C68821 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | LZI Norfentanyl Level 2 Control (6.25 ng/mL), Ref# C68822 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | LZI Norfentanyl Qualitative Calibrator (5 ng/mL), Ref# C68810 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | LZI Norfentanyl Semi-Quantitative Calibrator Set, Ref# C68811 | Kit: 4 dropper bottles; 15 mL each | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprcnorphinc, Intermediate Calibrator #2 (40 ng/mL), Ref# A68829 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine Level 2 Control (13 ng/mL), Ref# A68825 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine Low Calibrator (5 ng/mL), Ref# A68826 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine, Cutoff Calibrator (10 ng/mL), Ref# A68827 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine, High Calibrator (100 ng/mL), Ref# A68830 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine, Intermediate Calibrator #1 (20 ng/mL), Ref# A68828 | Dropper bottle: 5 mL | 6/9/2021 |
| Lin-Zhi International | Norbuprenorphine DAU Calibrator, Norbuprenorphine, Level 1 Control (7 ng/mL), Ref# A68824 | Dropper bottle: 5 mL | 6/9/2021 |
| Microgenics Corporation | Alinity c Benzodiazepines Qual Calibrator Kit, Catalog Number: 10027281/09P5201 | Kit: 1 vial, 2.9 mL | 4/2/2021 |
| Microgenics Corporation | Alinity c Cannabinoids Control 1 Kit, Catalog Number: 10024827/09P5410 | Kit: 2 LDPE, 5 mL each | 4/2/2021 |
| Microgenics Corporation | Alinity c Cannabinoids Control 2 Kit, Catalog Number: 10027212/09P5411 | Kit: 1 LDPE, 5 mL | 4/2/2021 |
| Microgenics Corporation | Alinity c Cannabinoids Qual Calibrator, Catalog Number: 10024821/09P5401 | Kit: 1 vial, 3.0 mL | 4/2/2021 |
| Microgenics Corporation | Alinity c Cannabinoids SemiQuant 100 Calibrator Kit, Catalog Number: 10026530/09P5402 | Kit: 3 vials, 3 mL each | 4/2/2021 |
| Microgenics Corporation | Alinity c Cannabinoids SemiQuant 200 Calibrator Kit, Catalog Number: 10026531/09P5403 | Kit: 3 vials, 3 mL each | 4/2/2021 |
| Microgenics Corporation | Alinity c Ecstasy Qual Calibrator Kit, Catalog Number: 10024822/09P5801 | Kit: 1 vial, 3.0 mL | 4/2/2021 |
| Microgenics Corporation | Alinity c Ecstasy Semiquant Calibrator Kit, Catalog Number: 10026532/09P5802 | Kit: 4 vials, 3.0 mL each | 4/2/2021 |
| Microgenics Corporation | Alinity c Opiates Qual Calibrator Kit, Catalog Number: 10024823/09P6501 | Kit: 1 vial, 3.0 mL | 4/2/2021 |
| Microgenics Corporation | Alinity c Opiates Semiquant Calibrator Kit, Catalog Number: 10026534/09P6502 | Kit: 4 vials, 3 mL each | 4/2/2021 |
| o2si Smart Solutions | Codeine monohydrate as codeine Solution, 2,000 mg/L-Parent Stock Solution-Not For Sale | Glass cryule: 2 mL | 5/28/2021 |
| o2si Smart Solutions | Heroin Solution, 2,000 mg/L-Parent Stock Solution-Not For Sale | Glass cryule: 2 mL | 5/28/2021 |
| o2si Smart Solutions | Hydrocodone (+)-bitartrate salt as hydrocodone Solution, 2,000 mg/L-Parent Stock Solution-Not For Sale | Glass cryule: 2 mL | 5/28/2021 |
| o2si smart solutions | ISO 17034-Custom Toxin/Poison Standard Kit, 45-46, 100 mg/L, 1 × 1 ml of Each Level (G34-140319-01, G34-140339-01, G34-140340-01) | Kit: 2 amber ampules, 1 mL each | 5/28/2021 |
| o2si smart solutions | ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10-318, 100 mg/L, 1 mL | Amber ampule: 1 mL | 5/28/2021 |
| o2si smart solutions | ISO 17034 Custom Toxin/Poison Stock Standard Mix, 10-319, 100 mg/L, 1 mL | Amber ampule: 1 mL | 5/28/2021 |
| o2si smart solutions | ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34-318, 100 mg/L, 1 mL | Amber ampule: 1 mL | 5/27/2021 |
| o2si Smart Solutions | ISO 17034 Custom Toxin/Poison Stock Standard Mix, 34-318, 100 mg/L, 1 mL | Amber ampule: 1 mL | 4/26/2021 |
| o2si smart solutions | Levorphanol (+)-tartrate salt dehydrate as levorphanol Solution, 2,000 mg/L-Parent Stock Solution-Not For Sale | Glass cryule: 2 mL | 5/28/2021 |
| o2si Smart Solutions | Oxycodone Solution, 2,000 mg/L-Parent Stock Solution-Not For Sale | Glass cryule: 2 mL | 5/28/2021 |
| o2si Smart Solutions | Pentazocine Solution, 2,000 mg/L-Parent Stock Solution | Glass cryule: 2 mL | 5/28/2021 |
| Restek Corporation | Custom D-Methamphetamine Standard | Glass Ampule: 1.3 mL | 4/15/2021 |
| UTAK Laboratories, Inc | DAU High Cutoff 1 Urine Control | Kit: 4 bottles, 10 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | DAU High Cutoff 2 Urine Control | Kit: 4 bottles, 10 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | DAU Low Cutoff 1 Urine Control | Kit: 4 bottles, 10 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | DAU Low Cutoff 2 Urine Control | Kit: 4 bottles, 10 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | Drugs of Abuse Level 1 Whole Blood Control | Kit: 5 bottles, 5 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | Fentanyl Analogues 2 NG/ML Whole Blood Control | Kit: 5 bottles, 3 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | Fentanyl Analogues 5 NG/ML Urine Control | Kit: 5 bottles, 3 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | PM 100 Urine Control | Kit: 5 bottles, 5 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | PM 100 Whole Blood Control | Kit: 5 bottles, 5 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | PM Plus High Urine Control | Kit: 5 bottles, 5 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | PM Plus Low Urine Control | Kit: 5 bottles, 5 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | SAMHSA Confirm Level 1 SMX Oral Fluid Control | Kit: 5 bottles, 3 mL each | 4/16/2021 |
| UTAK Laboratories, Inc | SAMHSA Confirm Level 2 SMX Oral Fluid Control | Kit: 5 bottles, 3 mL each | 4/16/2021 |
The Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart II below is not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23. Accordingly, the Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II below and specifically described in the application materials received by DEA, are not exempt from application of any part of the CSA or from application of any part of the CFR, with regard to the requested exemption pursuant to 21 CFR 1308.23, as of the date that was provided in the determination letters to the individual requesters.
| Supplier | Product name | Form | Application date |
|---|---|---|---|
| Aalto Scientific, Ltd | Immunoassy Base (Level A-E) | Glass vial, bottle, or flask: 500 mL-1L | 4/1/2021 |
| Aalto Scientific, Ltd | Immunoassy Base (Level A-E) | Glass vial, bottle, or flask: 100mL-500 mL | 4/1/2021 |
| Aalto Scientific, Ltd | Immunoassy Base (Level A-E) | Glass vial, bottle, or flask: 100 mL | 4/1/2021 |
Opportunity for Comment
Pursuant to 21 CFR 1308.23(e), any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.
Approved Exempt Chemical Preparations Are Posted on the DEA's Website
A list of all current exemptions, including those listed in this order, is available on the DEA's website at http://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01125 Filed 1-20-22; 8:45 am]
BILLING CODE 4410-09-P