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21 CFR 1310.08

§ 1310.08 Excluded transactions.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 1310.08, § 1310.08 Excluded transactions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92049
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Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following transactions has been determined to be unnecessary for the enforcement of the Chemical Diversion and Trafficking Act and, therefore, they have been excluded from the definitions of regulated transactions: (a) Domestic and import transactions of hydrochloric and sulfuric acids but not including anhydrous hydrogen chloride. (b) Exports, transshipments, and international transactions of hydrochloric (including anhydrous hydrogen chloride) and sulfuric acids, except for exports, transshipments and international transactions to the following countries: (1) Argentina (2) Bolivia (3) Brazil (4) Chile (5) Colombia (6) Ecuador (7) French Guiana (8) Guyana (9) Panama (10) Paraguay (11) Peru (12) Suriname (13) Uruguay (14) Venezuela (c) Domestic transactions of Methyl Isobutyl Ketone (MIBK). (d) Import transactions of Methyl Isobutyl Ketone (MIBK) destined for the United States. (e) Export transactions, international transactions, and import transactions for transshipment or transfer of Methyl Isobutyl Ketone (MIBK) destined for Canada or any country outside of the Western Hemisphere. (f) Domestic and international transactions of Lugol's Solution (consisting of 5 percent iodine and 10 percent potassium iodide in an aqueous solution) in original manufacturer's packaging of one-fluid-ounce (30 milliliters) or less, and no greater than one package per transaction. (g) Import transactions of anhydrous hydrogen chloride. (h) Domestic distribution of anhydrous hydrogen chloride weighing 12,000 pounds (net weight) or more in a single container. (i) Domestic distribution of anhydrous hydrogen chloride by pipeline. (j) Domestic and international return shipments of reusable containers from customer to producer containing residual quantities of red phosphorus or white phosphorus in rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2,500 gallons in a single container). (k) Domestic, import, and export distributions of gamma-butyrolactone weighing 4,000 kilograms (net weight) or more in a single container. (l) Domestic and import transactions in chemical mixtures that contain acetone, ethyl ether, 2-butanone, and/or toluene, unless regulated because of being formulated with other List I or List II chemical(s) above the concentration limit.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.