§1310.12. Exempt chemical mixtures.
21 C.F.R. § 1310.12
The chemical mixtures meeting the criteria in paragraphs (c) or (d) of this section 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) to the extent described in paragraphs (b) and (c) of this section.
No exemption granted pursuant to this § 1310.12 or § 1310.13 affects the criminal liability for illegal possession, distribution, exportation, or importation of listed chemicals contained in the exempt chemical mixture or the civil liability for unlawful acts related to exempt chemical mixtures, including distribution in violation of 21 U.S.C. 842(a)(11).
Mixtures containing a listed chemical in concentrations equal to or less than those specified in the “Table of Concentration Limits” are designated as exempt chemical mixtures for the purpose set forth in this section. The concentration is determined for liquid-liquid mixtures by using the volume or weight and for mixtures containing solids or gases by using the unit of weight.
The following categories of chemical mixtures are automatically exempt from the provisions of the Controlled Substances Act as described in paragraph (a) of this section:
Chemical mixtures that are distributed directly to an incinerator for destruction or directly to an authorized waste recycler or reprocessor where such distributions are documented on United States Environmental Protection Agency Form 8700-22; persons distributing the mixture to the incinerator or recycler must maintain and make available to agents of the Administration, upon request, such documentation for a period of no less than two years.
Completely formulated paints and coatings— Completely formulated paints and coatings are only those formulations that contain all of the components of the paint or coating for use in the final application without the need to add any additional substances except a thinner if needed in certain cases. A completely formulated paint or coating is defined as any clear or pigmented liquid, liquefiable or mastic composition designed for application to a substrate in a thin layer that is converted to a clear or opaque solid protective, decorative, or functional adherent film after application. Included in this category are clear coats, top-coats, primers, varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, temporary protective coatings and film-forming agents.
Iodine products classified as iodophors that exist as an iodine complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-iodine complex (i.e., povidone-iodine), undecoylium chloride iodine, nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex with phosphate ester of alkylaryloxy polyethylene glycol, and iodine complex with ammonium ether sulfate/polyoxyethylene sorbitan monolaurate.
Iodine products that consist of organically bound iodine (a non-ionic complex) (e.g., iopamidol, iohexol, and amiodarone.)
The Administrator may, at any time, terminate or modify the exemption for any chemical mixture which has been granted an exemption pursuant to the concentration limits as specified in paragraph (c) of this section or pursuant to the category exemption as specified in paragraph (d) 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 exemption for a product or group of products for which evidence of diversion has been found, as well as 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 shall immediately suspend the effectiveness of the order until he may reconsider the order in light of comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as determined appropriate.
The Administrator may modify any part of the criteria for exemption as specified in paragraphs (c) and (d) of this section upon evidence of diversion or attempted diversion. In doing so, the Administrator shall issue and publish a Notice of Proposed Rulemaking in the Federal Register. The Administrator shall permit any interested persons to file written comments on or objections to the proposal. After considering any comments or objections filed, the Administrator shall publish in the Federal Register a final order.
Notes, amendments, and revision history
Amendments
[68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, 2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24708, May 10, 2021; 86 FR 64366, Nov. 18, 2021; 87 FR 67552, Nov. 9, 2022; 88 FR 21909, Apr. 12, 2023; 88 FR 74359, Oct. 31, 2023; 90 FR 47566, Oct. 2, 2024; 91 FR 11455, Mar. 10, 2026; 91 FR 16836, Apr. 3, 2026]
Authority
Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890.
Source
Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
Amendments
[68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, 2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24708, May 10, 2021; 86 FR 64366, Nov. 18, 2021; 87 FR 67552, Nov. 9, 2022; 88 FR 21909, Apr. 12, 2023; 88 FR 74359, Oct. 31, 2023; 90 FR 47566, Oct. 2, 2024; 91 FR 11455, Mar. 10, 2026; 91 FR 16836, Apr. 3, 2026]