INSTRUCTIONS FOR COMPLETING DEA FORM 486

(IMPORT/EXPORT DECLARATION)

This form is to be used in notifying DEA of all imports, exports, and international transactions as required by the Controlled Substances Import and Export Act (21 U.S.C. 971). The following instructions supplement the parts of the DEA Form 486 that are not completely self-explanatory. Detailed requirements are found in Title 21 CFR Parts 1300, 1310 and 1313.

Initial Completion of Form

Fill in 1a – 5, except for 3d. For imports, fill in information for transferees in 7a – 7c, 8a -8c, and 9a - 9c. Sign at the bottom of page 1 and date. After your request is successfully processed by DEA, a transaction number will be issued for this transaction. The transaction number MUST be used for any action related to this transaction.

Completing Form Upon Completion of the Transaction

Upon completion of the import, export, or international transaction, fill in 3d, Date of Actual Import/Export and Actual Quantity for the entire transaction. For exporters and international transactions, not later than 30 days after the actual date of export or international transaction, complete 6, sign and date. For importers fill in 7d, 8d, and 9d, Name and Quantity of Chemical Actually Imported and Date for each Transferee, as appropriate. Not later than 30 days after the actual date of import, complete, sign, and date 7e, 8e, 9e, Return Declaration, as appropriate. If the entire quantity of chemicals imported is not distributed within 30 days, not later than 30 days after the next distribution is complete, sign, and date whatever portions of 7e, 8e, or 9e were distributed.

"List I chemical" means the following substances:

1. N-acetylanthranilic acid and its salts
2. Anthranilic acid and its salts
3. Benzaldehyde
4. Benzyl cyanide
5. Ephedrine and its salts, optical isomers, and salts of optical isomers
6. Ergonovine and its salts
7. Ergotamine and its salts
8. Ethylamine and its salts
9. gamma-Butyrolactone (GBL)
10. Hydriodic acid
11. Hypophosphorous acid and its salts,
12. Iodine
13. Isosafrole
14. Methylamine and its salts
15. 3,4-Methylenedioxphenyl-2-propanone
16. N-Methylephedrine and its salts, optical isomers, and salts of optical isomers
17. N-Methylpseudoephedrine and its salts, optical isomers, and salts of optical isomers
18. N-Phenethyl-4-piperidone (NPP)
19. Nitroethane
20. Norpseudoephedrine and its salts, optical isomers, and salts of optical isomers
21. Phenylacetic acid and its salts and esters
22. Phenylpropanolamine and its salts, optical isomers, and salts of optical isomers
23. Phosphorus (red)
24. Phosphorus (white or yellow)
25. Piperidine and its salts
26. Piperonal (heliotropine)
27. Propionic anhydride
28. Pseudoephedrine and its salts, optical isomers, and salts of optical isomers
29. Safrole

(See 21 CFR Part 1310 for updated list.)

"List II chemical" means the following substances:

1. Acetic anhydride
2. Acetone
3. Benzyl chloride
4. Ethyl ether
5. Hydrochloric acid
6. Hydrogen chloride gas
7. Methyl ethyl ketone (2-Butanone)
8. Methyl isobutyl ketone
9. Potassium permanganate
10. Sodium Permanganate
11. Sulfuric acid
12. Toluene

"Transferee" means a person/entity to whom an importer or exporter transfers (including sales) a listed chemical.

Part 1. The terms "Importer" and "Exporter" include the regulated person who, as the principal party in interest in the import or export transaction, has the power and responsibility for determining and controlling the bringing in or taking out of any chemical listed in 21 CFR 1310.02 that meets or exceeds the threshold quantity found in 21 CFR 1310.04. If the 15-day advance notification requirement has been waived, the regulated person must check block 1(c).

The term "Broker" means a legal entity that assists in arranging an international transaction in a listed chemical by (1) negotiating contracts; (2) serving as an agent or intermediary; or (3) fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing. Waiver of the 15-day advance notification does not apply to international transactions.

Part 2. The foreign consignor is the supplier of the chemical. The foreign transferee is the foreign person importing the chemical.

Part 3. EXAMPLES

Conversion Factors

Chemical	Percent	C.F.
Ephedrine HCl	81.92%	0.8192
Ephedrine Sulfate	77.12%	0.7712
Phenylpropanolamine HCL	80.57%	0.8057
Pseudoephedrine HCl	81.92%	0.8192
Pseudoephedrine Sulfate	77.12%	0.7712

3a. Name and Description of chemical appearing on label or container. For drug products, show dosage strength and dosage size.	3b. Name of chemicals as designated by Title 21 CFR 1310.02	3c. Number of containers, size, net weight of each chemical (kg)
For Bulk Piperonal	Piperonal	3 X 150 kg drums 450 kg net wt
For Drug Products (report in base weight) "Brand Name" tablets (ephedrine HCl)	Ephedrine	25 mg per tablet 100 tablets per bottle 48 bottles per case 100 cases per pallet 2 pallets = 24 kg 24 kg x 0.8192 = 19.66 kgs

INSTRUCTIONS FOR DISTRIBUTING DEA FORM 486

For Import Declaration distribute as follows: Copy 1 must be retained on file by the regulated person as the official record of import. Import declaration forms must be retained for two years. Copy 2 is a DEA copy. This form must be received at 8701 Morrissette Drive, Springfield, VA 22152 at least 15 days prior to importation. Regulated persons who have satisfied the requirements for waiver of the 15-day advance notice described in 21 CFR 1313.15 are required to provide notification on or before the day of importation. Copy 3 must be presented to U.S. Customs and Border Protection pursuant to 21 CFR 1313.14(c). Copy 4 is also a DEA copy and must be mailed to DEA not later than 30 days after the actual date of importation with the actual date of import, the actual quantity imported, and the Return Declaration filled in, signed, and dated (if faxed, Copy 2 can be updated and retransmitted). If the entire import is not distributed, not later than 30 days after the next distribution, complete, sign, and date a supplemental Return Declaration. The importer must file a supplemental Return Declarations not later than 30 days from the date of any further distribution until the disposition of all chemicals imported under the import notification have been distributed. Make a copy and mail or fax to DEA. Pursuant to 21 CFR 1313.14(c), a copy must be presented to U.S. Customs and Border Protection.

For Export Declaration distribute as follows: Copy 1 must be retained on file by the regulated person as the official record of export. Export declaration forms must be retained for two years. Copy 2 is a DEA copy. This form must be received at 8701 Morrissette Drive, Springfield, VA 22152 at least 15 days prior to exportation. Regulated persons who have satisfied the requirements for waiver of the 15-day advance notice described in 21 CFR 1313.24 are required to provide notification on or before the day of exportation. Copy 3 must be presented to U.S. Customs and Border Protection pursuant to 21 CFR 1313.23(c). Copy 4 is also a DEA copy and must be mailed to DEA not later than 30 days after the actual date of exportation with the actual date of export, the actual quantity exported, and the Return Declaration filled in with the name of the foreign importer, signed, and dated (if faxed, Copy 2 can be updated and retransmitted).

For International Transaction Declaration distribute as follows: Copy 1 must be retained on file by the broker or trader as the official record of the international transaction. Declaration forms must be retained for two years. Copy 2 is the DEA copy. Notification must be received at 8701 Morrissette Drive, Springfield, VA 22152 at least 15 days prior to the international transaction. Waiver of the 15-day advance notification does not apply to international transactions. Copy 3 is also a DEA copy and must be sent to DEA 30 days after the actual date of the international transaction with the actual date of international transaction, the actual quantity imported/exported, and the Return Declaration filled in, signed, and dated. Fax or mail to DEA.

DOWNLOAD DEA FORM 486 (PDF)

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Privacy Act Information

Authority: Section 1018 of the Controlled Substances Import and Export Act

Purpose: To obtain information regarding the import/export of certain chemicals to prevent the illicit manufacture of controlled substances.

Routine Uses: The Import/Export Declaration produces information required for law enforcement purposes. Disclosure of information is made to the following categories of users for the purposes stated:

1. Other Federal law enforcement and regulatory agencies for law enforcement and regulatory purposes.
2. State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes.
3. Person registered under the Controlled Substances Act (P.L. 91-513) for the purpose of verifying the registration of customers

Effect: Failure to complete this form will preclude the import/export of the chemicals mentioned.

Under the Paperwork Reduction Act, a person is not required to respond to a collection of information unless it displays a current valid OMB control number. Public report burden for this collection of information is estimated to average 12 minutes per response for exports and international transactions, 15 minutes per response for imports, and 5 minutes per response for Return Declarations, including the time for reviewing instructions, searching existing data source, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to the FOI and Records Management Section, Drug Enforcement Administration, Washington, D.C. 20537; and the Office of Management and budget, Paperwork Reduction Project No. 1117-486a, Washington, D.C. 20503.