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Regulations &
Codified CSA > CFR > Section 1310 > Section 1310.12
§ 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 § 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).
(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
| List I Chemicals |
DEA chemical code number |
Concentration |
Special conditions |
| N-Acetylanthranilic
acid, its salts |
8522 |
20% by
Weight |
Concentration
based on any and esters. combination of N- acetylanthranilic acid
and its salts and esters. |
| Anthranilic
acid, and its salts and esters. |
8530 |
50% by
Weight |
Concentration
is based on any 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, salts of optical isomers. |
8113 |
Not exempt at any concentration.
|
Chemical mixtures containing 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.
|
| Ergonovine
and its salts |
8675 |
Not exempt
at any concentration |
Chemical
mixtures containing any amount of ergonovine, including its
salts, are not exempt |
| Ergotamine
and its salts |
8676 |
Not exempt
at any concentration. |
Chemical
mixtures containing 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 |
|
|
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 isomers, and salts of optical isomers. |
8115 |
0.1% by
Weight |
Concentration
based on any combination of salts N- methylephedrine, N-
methylpseudoephedrine and their salts, optical isomers and salts
of optical isomers. |
| N-Methylpseudoephedrine,
its salts, optical isomers, and salts of optical isomers. |
8119 |
0.1% by
Weight |
Concentration
based on any combination of N- methylpseudoephedrine, N-
methylephedrine, and their salts, optical isomers and salts of
optical isomers. |
| Nitroethane |
6724 |
20% by
Weight or Volume |
|
|
N-phenethyl-4-piperidone (NPP)
|
8332
|
Not exempt at any concentration |
Chemical mixtures containing any amount of NPP are not exempt.
|
| Norpseudoephedrine,
its salts, optical isomers, and salts of optical isomers. |
8317 |
0.6% by
Weight |
Concentration
based on any combination of norpseudoephedrine,
phenylpropanolamine and their salts, optical isomers and salts of
optical isomers. |
| Phenylacetic
acid, and its salts and esters. |
8791 |
40% by
Weight |
Concentration
is based on any combination of phenylacetic acid and its salts and
esters. |
| Phenylpropanolamine,
its salts, optical isomers, and salts of optical combination of
isomers. |
1225 |
0.6% by
Weight |
Concentration
based on any 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 isomers, and salts of optical isomers. |
8112 |
Not exempt at any concentration.
|
Chemical mixtures containing 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.
|
| Safrole |
8323 |
20% by
Volume |
Concentration
in a mixture cannot exceed 20% if taken alone or in any
combination with isosafrole. |
|
List II Chemicals |
DEA chemical code number |
Concentration |
Special conditions |
| 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 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.
(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]
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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