Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Chemical Handler's Manual

APPENDIX E – Excluded Transactions

Information regarding this subject may be found at 21 U.S.C. § 802(39) and 21 C.F.R. § 1300.02(b).

The following transactions are not regulated:

  1. A domestic lawful distribution in the usual course of business between agents or employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person.
  2. Delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier or to or by a warehouseman for storage, unless the carriage or storage is in connection with the distribution, importation or exportation of a listed chemical to a third party, in which case this paragraph does not relieve a distributor, importer, or exporter from compliance with parts 1309, 1310, 1313 and 1315 of Title 21 of the Code of Federal Regulations.
  3. Any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by DEA regulations as excluded from this definition as unnecessary for enforcement of the Act.
  4. Any transaction in a listed chemical that is contained in a drug other than a scheduled listed chemical product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act subject to paragraph (v) of the definition of regulated transaction found at 21 C.F.R. § 1300.02(b) unless,
    1. the DEA has determined that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and
    2. the quantity of the listed chemical contained in the drug included in the transaction(s) equals or exceeds the threshold established for that chemical.
  5. Any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or distributor required to submit reports under 21 C.F.R. § 1310.03(c); or
  6. Any transaction in a chemical mixture designated in 21 C.F.R. §§ 1310.12 and 1310.13 that the DEA has exempted from regulation.

Additionally, the following transactions have been determined by the DEA to be excluded from the definition of regulated transaction. Information regarding this subject may be found at 21 C.F.R. § 1310.08:

Acetone, ethyl ether, 2-butanone, and/or toluene

  • 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.

Anhydrous hydrogen chloride

  • Exports, transshipments, and international transactions except for exports, transshipments, and international transactions to Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, French Guiana, Guyana, Panama, Paraguay, Peru, Suriname, Uruguay, and Venezuela
  • Import transactions
  • Domestic distributions weighing 12,000 pounds (net weight) or more in a single container
  • Domestic distributions by pipeline

Gamma-butyrolactone

  • Domestic, import, and export distributions of gamma-butyrolactone weighing 4,000 kilograms (net weight) or more in a single container

Hydrochloric acid and sulfuric acid (but not anhydrous hydrogen chloride)

  • Domestic and import transactions, exports, transshipments, and international transactions except for exports, transshipments, and international transactions to Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, French Guiana, Guyana, Panama, Paraguay, Peru, Suriname, Uruguay, and Venezuela

Iodine

  • Domestic and international transactions of Lugol's Solution (consisting of 5% iodine and 10% potassium iodide in an aqueous solution) in the original manufacturer's packaging of one fluid ounce (30 milliliters) or less, and no greater than one package per transaction

Methyl isobutyl ketone (MIBK)

  • Domestic transactions
  • Import transactions destined for the United States
  • Export transactions, international transactions, and import transactions for transshipment or transfer destined for Canada or any country outside of the Western Hemisphere

Red or white (also known as yellow) phosphorus

  • Domestic and international return shipments of reusable containers from customer to producer containing residual quantities of red or white (also known as yellow) phosphorus in rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2500 gallons in a single container)

 

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