Chemical Handler's Manual

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Appendix B

Thresholds for Regulated Transactions in List I Chemical
Thresholds for List I Chemicals in Drug Products

Thresholds for Regulated Transactions in List II Chemicals
Table of Concentration Limits for Mixtures Containing Ephedrine, N-Methylephedrine, N-Methylpseudoephedrine, Norpseudoephedrine, Phenylpropanolamine, or Pseudoephedrine
B-1: Excluded Transactions 21CFR 1310.08

Thresholds for Regulated Transactions in List I Chemicals

Excluded transactions are listed following the table "Thresholds for Regulated Transactions in List II Chemicals"

List I Chemical	Threshold by base weight
N-Acetylanthranilic acid and its salts and esters	40 kilograms
Anthranilic acid and its salts and esters	30 kilograms
Benzaldehyde	4 kilograms
Benzyl cyanide	1 kilogram
Ephedrine and its salts, optical isomers, and salts of optical isomers	0 kilograms
Ergonovine and its salts	10 grams
Ergotamine and its salts	20 grams
Ethylamine and its salts	1 kilogram
Gamma-butyrolactone	0 kilograms¹
Hydriodic acid (57%)	1.7 kilograms (or 1 liter by volume)
Hypophosphorous acid and its salts	0 kilograms¹
Isosafrole	4 kilograms
Methylamine and its salts	1 kilogram
3,4-Methyenedioxyphenyl-2-propanone	4 kilograms
N-Methylephedrine and its salts, optical isomers, and salts of optical isomers	1 kilogram
N-Methylpseudoephedrine and its salts, optical isomers, and salts of optical isomers	1 kilogram
Nitroethane	2.5 kilograms
Norpseudoephedrine and its salts, optical isomers, and salts of optical isomers	2.5 kilograms
Phenylacetic acid and its salts and esters	1 kilogram
Phenylpropanolamine and its salts, optical isomers, and salts of optical isomers	2.5 kilograms
Phosphorus, red, white	0 kilograms¹
Piperidine and its salts	500 grams
Piperonal	4 kilograms
Propionic anhydride	1 gram
Pseudoephedrine and its salts, optical isomers, and salts of optical isomers	1 kilogram
Safrole includes safrole-rich essential oils, such as sassafras oil and camphor oil 1070	4 kilograms

1 See Appendix B-1 for excluded transactions

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Appendix B

Thresholds for List I Chemicals in Drug Products

List I chemicals in Drug Products	Distributions by retail distributors	Distributions by mail order reporters	All other domestic distributions	Imports and exports
	Threshold by Base Weight
Ephedrine¹
As the sole therapeutically significant ingredient	No threshold – all transactions regulated	No threshold – all transactions regulated	No threshold – all transactions regulated	No threshold – all transactions regulated
In combination with therapeutically significant amounts of another medicinal ingredient	24 grams²	24 grams²	1 kilogram	1 kilogram
Pseudoephedrine¹
Other than ordinary over-the-counter products	9 grams^2,3	9 grams^2,3	1 kilogram	1 kilogram
Ordinary over-the-counter products	Exempt	9 grams^2,3	1 kilogram	1 kilogram
Phenylpropanolamine¹
Other than ordinary over-the-counter products	9 grams^2,3	9 grams^2,3	2.5 kilograms	2.5 kilograms
Ordinary over-the-counter products	Exempt	9 grams^2,3	2.5 kilograms	2.5 kilograms

1 And its salts, optical isomers, and salts of optical isomers

2 Per single transaction

3 Limited to packages of not more than three grams of base per package

Thresholds for Regulated Transactions in List II Chemicals

List II Chemicals	Domestic Sales		Imports and Exports
	By volume	By weight	By volume	By weight
Acetic anhydride	250 gallons	1023 kgs	250 gallons	1023 kgs
Acetone	50 gallons¹	150 kgs¹	500 gallons²	1500 kgs²
Benzyl chloride	Not applicable	1 kg	Not applicable	4 kgs
Ethyl ether	50 gallons	135.8 kgs	500 gallons	1364 kgs
Hydrochloric acid²	Not regulated	Not regulated	50 gallons³	Not applicable
Anhydrous hydrogen chloride²	Not applicable	0.0 kgs⁴	Not applicable	27 kgs³
Iodine	Not applicable	0.4 kgs	Not regulated	Not regulated
Potassium permanganate	Not applicable	55 kgs	Not applicable	500 kgs
Methyl ethyl ketone (2-Butanone)	50 gallons¹	145 kgs¹	500 gallons²	1455 kgs²
Methyl isobutyl ketone (MIBK)	Not regulated	Not regulated	500 gallons³	1523 kgs³
Sulfuric acid	Not regulated	Not regulated	50 gallons³	Not applicable
Toluene	50 gallons¹	159 kgs¹	500 gallons²	1591 kgs²

1 The cumulative threshold is not applicable to domestic sales of acetone, methyl ethyl ketone, and toluene.

2 The 15 day advance notification requirement for imports is waived. Importers must provide quarterly reports as indicated in 21 CFR 1313.12(e).

3 Threshold applies to exports, transshipments, and international transactions to western hemisphere except Canada. Imports are not regulated.

4 See Appendix B-1 for excluded transactions.

Table of Concentration Limits for Mixtures Containing Ephedrine, N-Methylephedrine, N-Methylpseudoephedrine, Norpseudoephedrine, Phenylpropanolamine, or Pseudoephedrine

List I chemicals	DEA chemical code	Concentration (percent)	Special conditions
Ephedrine, its salts, optical isomers, and salts of optical isomers.	8113	5% by Weight, (weight includes capsule, if any).	Concentration based on any combination of ephedrine, pseudoephedrine, and their salts, optical isomers and salts of optical isomers
N-Methylephedrine, its salts, optical isomers, and salts of optical isomers.	8115	0.1% by Weight, (weight includes capsule, if any).	Concentration based on any combination of 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 (weight includes capsule, if any).	Concentration based on any combination of N-methylpseudoephedrine, N-methylephedrine, and their salts, optical isomers and salts of optical isomers
Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers.	8317	0.6% by Weight (weight includes capsule, if any).	Concentration based on any com- bination of norpseudoephedrine, phenylpropanolamine and their salts, optical isomers and salts of optical isomers
Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers.	1225	0.6% by Weight (weight includes capsule, if any).	Concentration based on any combination of phenylpropanolamine, norpseudoephedrine and their salts, optical isomers and salts of optical isomers
Pseudoephedrine, its salts, optical isomers, and salts of optical isomers.	8112	5% by Weight, (weight includes capsule, if any).	Concentration based on any combination of pseudoephedrine, ephedrine, and their salts, optical isomers and salts of optical isomers

Excluded Transactions 21CFR 1310.08

The following transactions have been determined by DEA to be excluded from the definition of regulated transaction.

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, Venezuela

import transactions
domestic distribution weighing 12,000 pounds net weight or more in a single container
domestic distribution 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, Venezuela

Iodine

import and export transactions

Methyl isobutyl ketone (MIBK):

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

Red or white phosphorus

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 2500 gallons in a single container)

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