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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter II - Drug Enforcement Administration, Department of Justice |
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Part 1310 - Records and Reports of Listed Chemicals and Certain Machines |
§ 1310.13 - Exemption of chemical mixtures; application.
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§ 1310.13 Exemption of chemical mixtures; application.
(a) The Administrator may, by publication of a Final Rule in the Federal Register, exempt from the application of all or any part of the Act a chemical mixture consisting of two or more chemical components, at least one of which is not a List I or List II chemical, if:
(1) The mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and
(2) The listed chemical or chemicals contained in the chemical mixture cannot be readily recovered.
(b) Any manufacturer seeking an exemption for a chemical mixture, not exempt under § 1310.12, from the application of all or any part of the Act, may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
(c) An application for exemption under this section shall contain the following information:
(1) The name, address, and registration number, if any, of the applicant;
(2) The date of the application;
(3) The exact trade name(s) of the applicant's chemical mixture and:
(i) If the applicant formulates or manufactures the chemical mixture for other entities, the exact trade names of the chemical mixtures and the names of the entities for which the chemical mixtures were prepared; and
(ii) If a group of mixtures (e.g. formulations having identical function and containing the same listed chemical(s)), the information required in paragraph (c)(3)(i) of this section and a brief narrative of their use.
(4)
(i) The complete qualitative and quantitative composition of the chemical mixture (including all listed and all non-listed chemicals); or
(ii) If a group of mixtures, the concentration range for the listed chemical and a listing of all non-listed chemicals with respective concentration ranges.
(5)
(i) The chemical and physical properties of the mixture and how they differ from the properties of the listed chemical or chemicals; and
(ii) If a group of mixtures, how the group's properties differ from the properties of the listed chemical.
(6) A statement that the applicant believes justifies an exemption for the chemical mixture or group of mixtures. The statement must explain how the chemical mixture(s) meets the exemption criteria set forth in paragraph (a) of this section.
(7) A statement that the applicant accepts the right of the Administrator to terminate exemption from regulation for the chemical mixture(s) granted exemption under this section.
(8) The identification of any information on the application that is considered by the applicant to be a trade secret or confidential and entitled to protection under U.S. laws restricting the public disclosure of such information.
(d) The Administrator may require the applicant to submit such additional documents or written statements of fact relevant to the application that he deems necessary for determining if the application should be granted.
(e) Within a reasonable period of time after the receipt of an application for an exemption under this section, the Administrator will notify the applicant in writing of the acceptance or rejection of the application for filing. If the application is not accepted for filing, an explanation will be provided. The Administrator is not required to accept an application if any information required pursuant to paragraph (c) of this section or requested pursuant to paragraph (d) of this section is lacking or not readily understood. The applicant may, however, amend the application to meet the requirements of paragraphs (c) and (d) of this section. If the exemption is subsequently granted, the applicant shall again be notified in writing and the Administrator shall issue, and publish in the Federal Register, an order on the application. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order. If any comments or objections raise significant issues regarding any findings of fact or conclusions of law upon which the order is based, the Administrator may suspend the effectiveness of the order until he has reconsidered the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as deemed appropriate.
(f) The Administrator may, at any time, terminate or modify an exemption for any product pursuant to paragraph (e) of this section. In terminating or modifying an exemption, the Administrator shall issue, and publish in the Federal Register, notification of the removal of an exempt product or group of exempt products for which evidence of diversion has been found. This order shall specify the date on which the termination of exemption shall take effect. The Administrator shall permit any interested party to file written comments on or objections to the order within 60 days of the date of publication of the order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator may suspend the effectiveness of the order until he has reconsidered the order in light of comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as determined appropriate.
(g) A manufacturer of an exempted chemical mixture shall notify DEA in writing, of any change in the quantitative or qualitative composition of a chemical mixture that has been granted an exemption by application. Changes include those greater than the range of concentration given in the application or that remove non-listed chemical(s) given in the application as part of the formulation. A new application will be required only if reformulation results in a new product having a different commercial application or can no longer be defined as part of a group of exempted chemicals. DEA must be notified of reformulation at least 30 days in advance of marketing the reformulated mixture. For a change in name or other designation, code, or any identifier, a written notification is required. DEA must be notified of any changes at least 60 days in advance of the effective date for the change.
(h) Each manufacturer seeking exemption must apply for such an exemption. A formulation granted exemption by publication in the Federal Register will not be exempted for all manufacturers.
(i) The following chemical mixtures, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as exempt chemical mixtures for the purposes set forth in this section and are exempted by the Administrator from application of Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971):
Table 1 to Paragraph (i)—Exempt Chemical Mixtures
Manufacturer Product name1 Form Date Cerilliant Corporation 1R,2S(-)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation 1S,2R(+)-Ephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation 1S,2R(+)-Ephedrine-D3 hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation 1S,2R(+)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation Pseudoephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation R,R(-)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20) methylene chloride, or tetrahydrofuran Liquid 8/2/2007 Cerilliant Corporation S,S(+)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran Liquid 8/2/2007 E.I. DuPont deNemours & Co RC–5156 Liquid 4/22/2005 E.I. DuPont deNemours & Co VH–6037 Liquid 4/22/2005 GFS Chemicals WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 5 mg/ml Liquid 11/26/2018 GFS Chemicals WaterMark® Karl-Fisher Reagent, 5 mg/ml Single Solution NON–HAZ Liquid 11/26/2018 GFS Chemicals WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 2 mg/ml Liquid 11/26/2018 GFS Chemicals WaterMark® Karl-Fisher Reagent, 2 mg/ml Single Solution NON–HAZ Liquid 11/26/2018 GFS Chemicals WaterMark® Karl-Fisher Reagent, 5 mg/ml, Stabilized, Pyridine-Based Liquid 11/26/2018 Dr. Haces, L.L.C PodoPhylis, Podiatric Insole Polyurethane Iodine Insole 12/15/2021 Hawthorne Products, Inc Sole Pack Hoof Dressing Paste 8/14/2007 Hawthorne Products, Inc Sole Pack Hoof Packing Paste 8/14/2007 Lord Corporation Chemlok TS701–52 Liquid 05/03/2018 Lord Corporation Chemlok TS701–53 Liquid 05/03/2018 Mitsubishi Chemical Corporation Aquamicron AKX Liquid 04/08/2021 Mitsubishi Chemical Corporation Aquamicron AS Liquid 04/08/2021 Mitsubishi Chemical Corporation Aquamicron Titrant SS 1 mg Liquid 04/08/2021 Mitsubishi Chemical Corporation Aquamicron Titrant SS 3 mg Liquid 04/08/2021 Mitsubishi Chemical Corporation Aquamicron Titrant SS 10 mg Liquid 04/08/2021 Mitsubishi Chemical Corporation Aquamicron Titrant SS–Z 1 mg Liquid 09/01/2020 Mitsubishi Chemical Corporation Aquamicron Titrant SS–Z 3 mg Liquid 09/01/2020 Mitsubishi Chemical Corporation Aquamicron Titrant SS–Z 5 mg Liquid 04/08/2021 Quality Assurance Service Corporation 10 to 1000 nanograms per milliliter of ephedrine in blood, serum, or urine Liquid 9/26/2007 Quality Assurance Service Corporation 10 to 1000 nanograms per milliliter of pseudoephedrine in blood, serum, or urine Liquid 9/26/2007 Quality Assurance Service Corporation 10 to 1000 nanograms per milliliter of phenylpropanolamine in blood, serum, or urine Liquid 9/26/2007 Reichhold, Inc Beckosol® 12021–00 AA–200, IA–441, P531–T Liquid 5/05/2005 Reichhold, Inc Urotuf® L06–30S, F78–50T Liquid 5/05/2005 Reichhold, Inc Beckosol AA–220 Liquid 6/14/2005 Sigma-Aldrich Hydranal®-Composite 1 Liquid 5/29/2013 Sigma-Aldrich Hydranal®-Composite 2 Liquid 5/29/2013 Sigma-Aldrich Hydranal®-Composite 5K Liquid 5/29/2013 Sigma-Aldrich Hydranal®-Composite 5 Liquid 5/29/2013 Standard Homeopathic Co Baby Cough Syrup Liquid 9/28/2012 Standard Homeopathic Co Defend Cough & Cold Night Liquid 9/28/2012 Standard Homeopathic Co Defend Cough & Cold Liquid 9/28/2012 Standard Homeopathic Co Diarrex Liquid 9/28/2012 Waterbury Companies, Inc Waterbury 332500 Liquid 4/11/2005 Waterbury Companies, Inc Waterbury 332762 Liquid 4/11/2005 Waterbury Companies, Inc Waterbury 332400 Liquid 4/11/2005 Waterbury Companies, Inc Waterbury 346201 Liquid 4/11/2005 [68 FR 23204, May 1, 2003, as amended at 75 FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, 2010; 76 FR 31830, June 2, 2011; 81 FR 97025, Dec. 30, 2016; 85 FR 4586, Jan. 27, 2020; 88 FR 72682, Oct. 23, 2023]