[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1310.12] [Page 134-137] TITLE 21-FOOD AND DRUGS CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE PART 1310_RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES --Table of Contents Sec. 1310.12 Exempt chemical mixtures. (a) 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, and 1008 of the Act (21 U.S.C. 822, 823, 830, 957 and 958) to the extent described in paragraphs (b) and (c) of this section. (b) No exemption granted pursuant to this Sec. 1310.12 or Sec. 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). (c) 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. Table of Concentration Limits ---------------------------------------------------------------------------------------------------------------- DEA chemical Concentration Special conditions code number ---------------------------------------------------------------------------------------------------------------- List I Chemicals ---------------------------------------------------------------------------------------------------------------- N-Acetylanthranilic acid, its salts and 8522 20% by Weight............. Concentration based on any esters. combination of N- acetylanthranilic acid and its salts and esters. Anthranilic acid, and its salts and 8530 50% by Weight............. Concentration is based on any esters. combination of anthranilic acid and its salts and esters. Benzaldehyde........................... 8256 50% by Weight or Volume... Benzyl cyanide......................... 8570 20% by Weight or Volume... Ephedrine, its salts, optical isomers, 8113 5% by Weight, net weight Concentration based on any and salts of optical isomers. includes capsule, if any. combination of ephedrine, pseudoephedrine, and their salts, optical isomers and salts of optical isomers. Ergonovine and its salts............... 8675 Not exempt at any Chemical mixtures containing concentration. any amount of ergonovine, including its salts, are not exempt. [[Page 135]] Ergotamine and its salts............... 8676 Not exempt at any Chemical mixtures containing concentration. amount of any ergotamine, including its salts, are not exempt. Ethylamine and its salts............... 8678 20% by Weight or Volume... Ethylamine or its salts in an inert carrier solvent is not considered a mixture. Concentration is based on ethylamine in the mixture and not the combination of ethylamine and carrier solvent, if any. Hydriodic acid......................... 6695 20% by Weight or Volume... Isosafrole............................. 8704 20% by Weight or Volume... Concentration in a mixture cannot exceed 20% if taken alone or in any combination with safrole. Methylamine and its salts.............. 8520 20% by Weight............. Methylamine or its salts in an inert carrier solvent is not considered a mixture. Weight is based on methylamine in the mixture and not the combined weight of carrier solvent, if any. 3,4-Methylenedioxyphenyl-2-propanone... 8502 20% by Weight............. N-Methylephedrine, its salts, optical 8115 0.1% by Weight............ Concentration based on any isomers, and salts of optical isomers. combination of salts N- methylephedrine, N- methylpseudoephedrine and their salts, optical isomers and salts of optical isomers. N-Methylpseudoephedrine, its salts, 8119 0.1% by Weight............ Concentration based on any optical isomers, and salts of optical combination of N- isomers. methylpseudoephedrine, N- methylephedrine, and their salts, optical isomers and salts of optical isomers. Nitroethane............................ 6724 20% by Weight or Volume... Norpseudoephedrine, its salts, optical 8317 0.6% by Weight............ Concentration based on any isomers, and salts of optical isomers. combination of norpseudoephedrine, phenylpropanolamine and their salts, optical isomers and salts of optical isomers. Phenylacetic acid, and its salts and 8791 40% by Weight............. Concentration is based on any esters. combination of phenylacetic acid and its salts and esters. Phenylpropanolamine, its salts, optical 1225 0.6% by Weight............ Concentration based on any isomers, and salts of optical isomers. combination of phenylpropanolamine, norpseudoephedrine and their salts, optical isomers and salts of optical isomers. Piperidine, and its salts.............. 2704 20% by Weight or Volume... Concentration based on any combination of piperidine and its salts. Concentration based on weight if a solid, weight or volume if a liquid. Piperonal.............................. 8750 20% by Weight or Volume... Propionic anhydride.................... 8328 20% by Weight or Volume... Pseudoephedrine, its salts, optical 8112 5% by Weight, net weight Concentration based on any isomers, and salts of optical isomers. includes capsule, if any. combination of pseudoephedrine, ephedrine, and their salts, optical isomers and salts of optical isomers. Safrole................................ 8323 20% by Volume............. Concentration in a mixture cannot exceed 20% if taken alone or in any combination with isosafrole. ---------------------------------------- List II Chemicals ---------------------------------------------------------------------------------------------------------------- Acetic Anhydride....................... 8519 20% by Weight or Volume... Acetone................................ 6532 35% by Weight or Volume... Exports only; Limit applies to acetone or any combination of acetone, ethyl ether, 2- butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Benzyl chloride........................ 8568 20% by Weight or Volume... 2-butanone............................. 6714 35% by Weight or Volume... Exports only; Limit applies to 2-butanone or any combination of acetone, ethyl ether, 2- butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Ethyl ether............................ 6584 35% by Weight or Volume... Exports only; Limit applies to ethyl ether or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Hydrochloric acid...................... 6545 20% by Weight or Volume... Hydrogen chloride in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on hydrogen chloride in the mixture and not the combined weight of the carrier solvent, if any. [[Page 136]] Methyl isobutyl ketone................. 6715 35% by Weight or Volume... Exports only pursuant to Sec. 1310.08; Limit applies to methyl isobutyl ketone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Potassium permanganate................. 6579 15% by Weight............. Sulfuric acid.......................... 6552 20% by Weight or Volume... Sulfuric acid in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on sulfuric acid in the mixture and not the combined weight of the carrier solvent, if any. Toluene................................ 594 35% by Weight or Volume... Exports only; Limit applies to toluene or any combination of acetone, ethyl ether, 2- butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. ---------------------------------------------------------------------------------------------------------------- (d) 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: (1) Harvested plant material that contains ephedrine, N- methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine, that is in its natural state or has been processed in a way (such as grinding, chopping, mulching or cutting) that preserves the natural constituents in the ratios that are found in the plant's natural state. Plant material subjected to chemical or physical extraction, concentration, chemical reaction, or other treatment that alters the plant's natural constituents or the ratios of the plant constituents are not exempt. (2) 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. (3) Completely formulated paints and coatings: Completely formulated paints and coatings are only those formulations that contain all 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, topcoats, primers, varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, and temporary protective coatings. (e) 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 [[Page 137]] 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. (f) 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. [68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004]