(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, 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.
(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 Not exempt at any Chemical mixtures containing
and salts of optical isomers. concentration. any amount of ephedrine and/
or pseudoephedrine, and their
salts, optical isomers and
salts of optical isomers are
not exempt due to
concentration, unless
otherwise exempted.Ergocristine and its salts............. 8612 Not exempt at any Chemical mixtures containing
concentration. any amount of ergocristine
and its salts are not exempt.Ergonovine and its salts............... 8675 Not exempt at any Chemical mixtures containing
concentration. any amount of ergonovine,
including its salts, are not
exempt.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.Gamma-Butyrolactone.................... 2011 70% by weight or volume.Hydriodic acid......................... 6695 20% by Weight or Volume...Hypophosphorous acid and its salts..... 6797 30% by weight if a solid, The weight is determined by
weight or volume if a measuring the mass of
liquid. hypophosphorous acid and its
salts in the mixture, the
concentration limit is
calculated by summing the
concentrations of all forms
of hypophosphorous acid and
its salts in the mixture. The
Administration does not
consider a chemical mixture
to mean the combination of a
listed chemical and an inert
carrier. Therefore, any
solution consisting of
hypophosphorous acid (and its
salts), dispersed in water,
alcohol, or another inert
carrier, is not considered a
chemical mixture and is
therefore subject to chemical
regulatory controls at all
concentrations.Iodine................................. 6699 2.2....................... Calculated as weight/volume (w/
v).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.N-phenethyl-4-piperidone (NPP)......... 8332 Not exempt at any Chemical mixtures containing
concentration. any amount of NPP are not
exempt.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 Not exempt at any Chemical mixtures containing
isomers, and salts of optical isomers. concentration. any amount of ephedrine and/
or pseudoephedrine, and their
salts, optical isomers and
salts of optical isomers are
not exempt due to
concentration, unless
otherwise exempted.Red Phosphorus......................... 6795 80% by weight.Safrole................................ 8323 20% by Volume............. Concentration in a mixture
cannot exceed 20% if taken
alone or in any combination
with isosafrole.White phosphorus....................... 6796 Not exempt at any Chemical mixtures containing
concentration. any amount of white
phosphorus are not exempt due
to concentration, unless
otherwise exempted.
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.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.............Sodium Permanganate.................... 6588 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) 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.
(2) 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.
(3) 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.
(4) Iodine products that consist of organically bound iodine (a non-ionic complex) (e.g., iopamidol, iohexol, and amiodarone.)
(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 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; 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]