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Section 1310 > Section 1310.04
Section 1310.04 Maintenance of records.
(a) Every record required to be kept subject to Sec. 1310.03 for a List I chemical, a tableting
machine, or an encapsulating machine shall be kept by the regulated person for 2 years after the
date of the transaction.
(b) Every record required to be kept subject to Section 1310.03 for List II chemical shall be kept
by the regulated person for two years after the date of the transaction.
(c) A record under this section shall be kept at the regulated person's place of business where the
transaction occurred, except that records may be kept at a single, central location of the regulated
person if the regulated person has notified the Administration of the intention to do so. Written
notification must be submitted by registered or certified mail, return receipt requested, to the
Special Agent in Charge of the DEA Divisional Office for the area in which the records are
required to be kept.
(d) The records required to be kept under this section shall be readily retrievable and available for
inspection and copying by authorized employees of the Administration under the provisions of
21 U.S.C. 880.
(e) The regulated person with more than one place of business where records are required to be
kept shall devise a system to detect any party purchasing from several individual locations of the
regulated person thereby seeking to avoid the application of the cumulative threshold or evading
the requirements of the Act.
(f) For those listed chemicals for which thresholds have been established, the quantitative
threshold or the cumulative amount for multiple transactions within a calendar month, to be
utilized in determining whether a receipt, sale, importation or exportation is a regulated
transaction is as follows:
(1) List I Chemicals:
(i) Except as provided in paragraph (f)(1)(ii) of this section, the
following thresholds have been established for List I chemicals.
Chemical |
Threshold by base weight |
(A)
Anthranilic acid, its esters, and its salts. |
30
kilograms |
(B) Benzyl
cyanide |
1 kilogram |
(C)
Ergonovine and its salts |
10 grams. |
(D)
Ergotamine and its salts |
20 grams |
(E) N-Acetylanthranilic
acid, its esters, and its salts. |
40
kilograms |
(F)
Norpseudoephedrine, its salts, .optical isomers, and salts of
opticalisomers. |
2.5 kilograms |
(G)
Phenylacetic acid, its esters, and its salts. |
1 kilogram |
(H)
Phenylpropanolamine, its salts, .optical isomers, and salts of
opticalisomers. |
2.5
kilograms |
(I)
Piperidine and its salts |
500 grams |
(J) Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers. |
1 kilogram |
(K)
3,4-Methylenedioxyphenyl-2-propanone |
4 kilograms |
(L)
Methylamine and its salts |
1 kilogram |
(M)
Ethylamine and its salts |
1 kilogram |
(N)
Propionic anhydride |
1 gram |
(O)
Isosafrole |
4 kilograms |
(P) Safrole |
4 kilograms |
(Q)
Piperonal |
4 kilograms |
(R) N-Methylephedrine,
its salts, optical isomers, and salts of optical isomers (N-Methylephedrine). |
1 kilogram |
(S) N-Methylpseudoephedrine,
its salts, optical isomers, and salts of optical isomers. |
1 kilogram |
(T)
Hydriodic Acid |
1.7
kilograms (or 1 liter by
volume) |
(U)
Benzaldehyde |
4 kilograms |
(V)
Nitroethane |
2.5
kilograms |
(ii) For List I chemicals that are scheduled
listed chemical products as defined in Sec.
1300.02, the thresholds
established in paragraphs (f)(1)(i) and (g) of this section apply only to
non-retail distribution, import, and export. Sales of these products at retail
are subject to the requirements of part 1314 of this chapter.
Chemical |
Threshold by
weight |
(A)
Ephedrine, its salts, optical . isomers, and salts of
optical isomers as the sole therapeutically significant medicinal
ingredient. |
No threshold. All transactions regulated. |
(B)
Ephedrine, its salts, optical isomers, and salts of optical
isomers in combination with therapeutically significant amounts of
another medicinal ingredient: |
|
|
(1)
Distributions by retail distributors. |
24
grams. |
|
(2) Distributions by
persons required to report under § 1310.03(c) of this part. |
24 grams |
|
3) All other domestic
distributions. (other than paragraphs (f)(1)(ii)(B) (1) and (2) of
this section). |
1 kilogram |
|
(4) Imports and Exports |
1 kilogram |
(C)
Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers (other than ordinary over-the-counter products): |
|
|
(1) Distributions by
retail distributors. |
9
grams, sold in pkgs sizes of not more than 3 grams of
pseudoephedrine base. |
|
(2) Distributions by
persons required .to report under §1310.03(c)
of this
part. |
9
grams, sold in pkgs sizes of not more than 3 grams of
pseudoephedrine base. |
|
(3) All other domestic
distributions, (other than paragraphs (f)(1)(ii)(C)(1)
and (2) of this section). |
1 kilogram. |
|
(4) Imports and
Exports |
1 kilogram. |
(D) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers (ordinary over-the-counter products): |
|
|
(1) Distributions by retail distributors. |
Exempt. |
|
(2) Distributions by persons required
to report under § 1310.03(c) of
this part. |
9
grams, sold in pkgs sizes of not more than 3 grams of
pseudoephedrine base. |
|
(3) All other domestic distributions
(other than paragraphs (f)(1)(ii)(D)
(1) and (2) of this section). |
1 kilogram. |
|
(4) Imports and Exports |
1 kilogram. |
(E)
Phenylpropanolamine, its salts,
optical isomers, and salts of optical
isomers (other than ordinary over-the-counter products): |
|
|
(1) Distributions by retail distributors. |
9
grams, sold in pkgs sizes of not more than 3 grams of
phenylpropanolamine base. |
|
(2) Distributions by persons required to report under § 1310.03(c)
of
this part. |
9
grams, sold in pkgs sizes of not more than 3 grams of
phenylpropanolamine base. |
|
(3) All other domestic distributions
(other than paragraphs (f)(1)(ii)(E)
(1) and (2) of this section). |
2.5 kilograms. |
|
(4) Imports and Exports |
2.5 kilograms. |
(F)
Phenylpropanolamine, its salts,
optical isomers, and salts of optical
isomers (ordinary over-the-counter
products): |
|
|
(1) Distributions by retail
distributors. |
Exempt. |
|
(2) Distributions by persons required
to report under § 1310.03(c) of
this part. |
9
grams, sold in pkgs sizes of not more than 3 grams of
phenylpropanolamine base. |
|
(3) All other domestic distributions
(other than paragraphs (f)(1)(ii)(F)
(1) and (2) of this section). |
2.5 kilograms. |
|
(4) Imports and Exports |
2.5 kilograms. |
(2) List II Chemicals:
(i) Imports and Exports
Chemical
|
Threshold
by volume
|
Threshold
by weight
|
(A) Acetic
anhydride
|
250 gallons
|
1,023
kilograms.
|
(B) Acetone
|
500 gallons
|
1,500
kilograms.
|
(C) Benzyl
chloride
|
N/A
|
4 kilograms.
|
(D) Ethyl
ether
|
500 gallons
|
1,364
kilograms.
|
(E) Potassium
permanganate
|
N/A
|
500
kilograms.
|
(F)
2-Butanone (MEK)
|
500 gallons
|
1,455
kilograms.
|
(G) Toluene
|
500 gallons
|
1,591
kilograms.
|
(H) Sodium permanganate
|
N/A
|
500 kilograms
|
(ii) Domestic Sales
Chemical
|
Threshold
by volume
|
Threshold
by weight
|
(A) Acetic
anhydride
|
250 gallons
|
1,023
kilograms.
|
(B) Acetone
|
50 gallons
|
150
kilograms.
|
(C) Benzyl
chloride
|
N/A
|
1 kilograms.
|
(D) Ethyl
ether
|
50 gallons
|
135.8
kilograms.
|
(E) Potassium
permanganate
|
N/A
|
55 kilograms.
|
(F)
2-Butanone (MEK)
|
50 gallons
|
145
kilograms.
|
(G) Toluene
|
50 gallons
|
159
kilograms.
|
(H)
Anhydrous Hydrogen chloride |
N/A |
0.0
kilograms. |
(I) Sodium permanganate
|
N/A
|
55 kilograms
|
(iii) The cumulative threshold is not applicable to domestic sales of Acetone,
2-Butanone (MEK), and Toluene.
(iv) Exports, Transshipments and
International Transactions to Designated Countries
set forth in Sec. 1310.08(b)
Chemical |
Threshold by volume |
Threshold by weight |
(A) Hydrochloric acid |
50 gallons |
|
(1) Anhydrous Hydrogen chloride
|
|
27 kilograms. |
(B) Sulfuric acid |
50 gallons |
|
(v) Export and International Transactions to Designated Countries, and
Importations for Transshipment or Transfer to Designated Countries
Chemical
|
Threshold
by volume
|
Threshold
by weight
|
(A) Methyl Isobutyl Ketone (MIBK).
|
500 gallons
|
1523 kilograms.
|
(B) Reserved.
|
|
|
(g) For listed chemicals for which no thresholds
have been established, the size of the transaction is not a factor in
determining whether the transaction meets the definition of a regulated
transaction as set forth in Sec.
1300.02(b)(28) of this chapter. All such transactions, regardless of
size, are subject to recordkeeping and reporting requirements as set forth
in this part and notification provisions as set forth in part
1313 of this chapter.
(1) Listed chemicals for which no thresholds have
been established:
(i) Ephedrine, its salts, optical isomers and
salts of optical isomers
(ii) Red phosphorus
(iii) White phosphorus (Other names: Yellow Phosphorus)
(iv) Hypophosphorous acid and its salts
(v) gamma-Butyrolactone
(Other names include: GBL; Dihydro-2(3H)- furanone; 1,2-Butanolide;
1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric
acid lactone)
(vi) N-phenethyl-4-piperidone
(NPP)
(vii) Iodine
(2) [Reserved]
(h) The thresholds and conditions in
paragraphs (f) and (g) of this section will apply to transactions
involving regulated chemical mixtures. For purposes of determining
whether the weight or volume of a chemical mixture meets or exceeds
the applicable quantitative threshold, the following rules apply:
(1) For chemical mixtures containing
List I chemicals or List II chemicals other than those in paragraph
(h)(2) of this section, the threshold is determined by the weight of
the listed chemical in the chemical mixture.
(2) For the List II chemicals acetone,
ethyl ether, 2-butanone, toluene, and methyl isobutyl ketone, the
threshold is determined by the weight of the entire chemical mixture.
(3) If two or more listed chemicals are
present in a chemical mixture, and the quantity of any of these
chemicals equals or exceeds the threshold applicable to that chemical,
then the transaction is regulated.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22,
1992; 59 FR 51367, Oct. 11, 1994; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, June 22, 1995; 60
FR 42436, Aug. 16, 1995; 62 FR 5917, Feb. 10, 1997;
65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17,
2001; 67 FR 14861, Mar. 28, 2002;
68 FR 11472, Mar. 11, 2003; 68 FR 23203, May 1, 2003; 68 FR 53292, Sept. 10, 2003; 68 FR 57804, Oct. 7,
2003; 69 FR 74970, Dec. 15, 2004; 71 FR 56024, Sept. 26, 2006; 71
FR 60826, Oct 17, 2006; Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR
40238, July 24, 2007]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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