21 C.F.R. § 1310.04 Maintenance of records.
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
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§ 1310.04 Maintenance of records.
(a) Every record required to be kept subject to §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 30 kilograms. salts.(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, 40 kilograms. and its salts.(F) Norpseudoephedrine, its salts, optical 2.5 kilograms. isomers, and salts of optical isomers.(G) Phenylacetic acid, its esters, and its 1 kilogram. salts.(H) Phenylpropanolamine, its salts, 2.5 kilograms. optical isomers, and salts of optical isomers.(I) Piperidine and its salts.............. 500 grams.(J) Pseudoephedrine, its salts, optical 1 kilogram. isomers, and salts of optical isomers.(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 1 kilogram. isomers, and salts of optical isomers (N- Methylephedrine).(S) N-Methylpseudoephedrine, its salts, 1 kilogram. optical isomers, and salts of optical isomers.(T) Hydriodic Acid........................ 1.7 kilograms (or 1 liter by volume).(U) Benzaldehyde.......................... 4 kilograms.(V) Nitroethane........................... 2.5 kilograms.------------------------------------------------------------------------
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(ii) Notwithstanding the thresholds established in paragraphs (f)(1)(i) and (g) of this section, the following thresholds will apply for the following List I chemicals that are contained in drug products that are regulated pursuant to §1300.02(b)(28)(i)(D) of this chapter (thresholds for retail distributors and distributors required to report under §1310.03(c) of this part are for a single transaction; the cumulative threshold provision does not apply. All other distributions are subject to the cumulative threshold provision.):
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------------------------------------------------------------------------ Chemical Threshold by weight------------------------------------------------------------------------(A) Ephedrine, its salts, optical isomers, No threshold. All and salts of optical isomers as the sole transactions regulated. therapeutically significant medicinal ingredient.(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 24 grams. distributors. (2) Distributions by persons required 24 grams. to report under § 1310.03(c) of this part. (3) All other domestic distributions 1 kilogram. (other than paragraphs (f)(1)(ii)(B) (1) and (2) of this section). (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 9 grams, and sold in package distributors. sizes of not more than 3 grams of pseudoephedrine base. (2) Distributions by persons required 9 grams, and sold in package to report under § 1310.03(c) of sizes of not more than 3 this part. grams of pseudoephedrine base. (3) All other domestic distributions, 1 kilogram. (other than paragraphs (f)(1)(ii)(C) (1) and (2) of this section). (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 Exempt. distributors. (2) Distributions by persons required 9 grams, and sold in package to report under § 1310.03(c) of sizes of not more than 3 this part. grams of pseudoephedrine base. (3) All other domestic distributions 1 kilogram. (other than paragraphs (f)(1)(ii)(D) (1) and (2) of this section). (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 9 grams, and sold in package distributors. sizes of not more than 3 grams of phenylpropanolamine base. (2) Distributions by persons required 9 grams, and sold in package to report under § 1310.03(c) of sizes of not more than 3 this part. grams of phenylpropanolamine base. (3) All other domestic distributions 2.5 kilograms. (other than paragraphs (f)(1)(ii)(E) (1) and (2) of this section). (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 Exempt. distributors. (2) Distributions by persons required 9 grams, and sold in package to report under § 1310.03(c) of sizes of not more than 3 this part. grams of phenylpropanolamine base. (3) All other domestic distributions 2.5 kilograms. (other than paragraphs (f)(1)(ii)(F) (1) and (2) of this section). (4) Imports and Exports............... 2.5 kilograms.------------------------------------------------------------------------
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(2) List II Chemicals:
(i) Imports and Exports
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---------------------------------------------------------------------------------------------------------------- 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.----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- 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 kilogram.(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) Iodine............................. N/A................................ 0.4 kilograms.(I) Anhydrous Hydrogen chloride........ N/A................................ 0.0 kilograms.----------------------------------------------------------------------------------------------------------------
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(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 as Set Forth in §1310.08(b).
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------------------------------------------------------------------------ Threshold by Chemical volume Threshold by weight------------------------------------------------------------------------(A) Hydrochloric acid.......... 50 gallons (1) Anhydrous Hydrogen .................. 27 kilograms. chloride.(B) Sulfuric acid.............. 50 gallons------------------------------------------------------------------------
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(v) Export and International Transactions to Designated Countries, and Importations for Transshipment or Transfer to Designated Countries
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------------------------------------------------------------------------ Threshold by Chemical volume Threshold by weight------------------------------------------------------------------------(A) Methyl Isobutyl Ketone 500 gallons....... 1523 kilograms. (MIBK).(B) Reserved.------------------------------------------------------------------------
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(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 §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)
(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]
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