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Required by 21 CFR > Chemical
Reports > DEA Form 486 Instructions
INSTRUCTIONS FOR COMPLETING
IMPORT/EXPORT DECLARATION, DEA FORM 486
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:
- N-acetylanthranilic acid and its
salts
- Anthranilic
acid and its salts
- Benzaldehyde
- Benzyl cyanide
- Ephedrine and its salts, optical isomers, and salts of
optical isomers
- Ergonovine and its salts
- Ergotamine and its salts
- Ethylamine and its salts
- gamma-Butyrolactone (GBL)
- Hydriodic acid
- Hypophosphorous acid and its salts,
- Iodine
- Isosafrole
- Methylamine and its salts
- 3,4-Methylenedioxphenyl-2-propanone
- N-Methylephedrine and its salts, optical isomers, and
salts of optical isomers
- N-Methylpseudoephedrine and its salts, optical isomers,
and salts of optical isomers
- N-Phenethyl-4-piperidone (NPP)
- Nitroethane
- Norpseudoephedrine and its salts, optical isomers, and
salts of optical isomers
- Phenylacetic acid and its salts and esters
- Phenylpropanolamine and its salts, optical isomers, and
salts of optical isomers
- Phosphorus (red)
- Phosphorus (white or yellow)
- Piperidine and its salts
- Piperonal (heliotropine)
- Propionic anhydride
- Pseudoephedrine and its salts, optical isomers, and salts
of optical isomers
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
(See 21 CFR Part 1310 for updated list.)
"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
|
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 or sent via electronic facsimile to telephone no. 202-307-4702 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 or via electronic facsimile to telephone no. 202-307-4702 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 or via electronic facsimile
to telephone no. 202-307-4702 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
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:
A. Other Federal law enforcement and
regulatory agencies for law enforcement and regulatory purposes.
B. State and local law enforcement and
regulatory agencies for law enforcement and regulatory purposes.
C. 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.
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