REPORTING > Reports Required by 21 CFR > Import/Export Permit Applications and Declarations > DEA FORM 161R
DEA FORM 161R
DEA Form 161R - Application for Permit to Export Controlled Substances for Subsequent Reexport (PDF)
This application must be completed in triplicate. The original is sent to DEA HQs: Drug Enforcement Administration, Diversion Control Division, Import/Export Unit, 8701 Morrissette Drive, Springfield, VA 22152. See Instructions 5a and 9 for copies two and three.
(1) The name and address of the consignee as shown on this application and on the permit to export must correspond with that shown on the foreign import certificate.
(2) To avoid delays in clearance at the port of export, be sure to enter the correct port on this application. A copy of your export permit is sent directly to the District Director of Customs at the port indicated on the application for comparison with the permit presented for clearance of the shipment. The shipment will not clear at any other port without an amendment of the permit indicating a change to that effect.
(3) The original or an authentic signed and/or notarized copy of the foreign import certificate must accompany this application. If this certificate is in a foreign language, a translation must accompany the application. If this certificate is needed to accomplish entry of the drug into the country of destination, your request for its return to you should accompany the application.
(4) Application should be made in the name of the registered legal entity, as shown on the DEA registration certificate, and signed by a responsible authorized official if a corporation, by a partner, or by the person registered as an individual. Only persons registered to export may be issued export permits. The registrations of manufacturers, distributors, practitioners, researchers, etc. do not entitle them to export controlled substances.
(5) Controlled substances in Schedule I or II, or a narcotic drug in Schedule III or IV may be exported from the United States to a country for subsequent export from that country to another country:
a. Thirty days from the date of exportation from the United States to the first country, the exporter must return Copy 2 of Form DEA 161R with 7c completed, that is, with the actual date of export and actual quantity shipped.
b. The controlled substances must be exported from the first country to the second country no later than 180 days from the date of exportation from the United States
c. Within 30 days after the controlled substance is exported from the first country to the second country or the order is canceled by the second country, the person who exported the controlled substance from the United States must deliver to DEA Headquarters documentation certifying that such export from the first country to the second country has occurred or was refused.
i. The company must provide on company letterhead signed by a responsible company official the following information: (1) Name of the second country, (2) actual quantity shipped, (3) actual date shipped, and (4) DEA export permit number for the original export to the first country.
ii. For refused shipments, the company must file a written request with DEA for return, a brief summary of the facts warranting the return, and a DEA Form 357, Application for Import Permit. DEA will evaluate the request and return a response in writing.
(6) Permits will be mailed to the exporter at the address shown at the bottom of the application unless contrary instructions are attached to and made a part of this application.
(7) Identification of drugs to be exported and the controlled substance content should be entered on the application in the following manner:
|8a. NAME AND QUANTITY OF DRUG OR
PREPARATIONS TO BE EXPORTED
|8b. CONTROLLED SUBSTANCE CONTENT OF
DRUG OR PREPARATION TO BE EXPORTED
(expressed as acid, base or alkaloid, not salt)
|3 bottles x 100 Secobarbital Sodium capsules (100
|Secobarbital 24.47 gm|
|2 boxes x 100 Meperidine HCL ampules (5%, 2ml
|Meperidine 17.43 gm|
|1 box x 100 Meperidine HCl vials (10%, 20 ml, vials)||Meperidine 174.30 gm|
|2 x 1 pt. Meperidine HCL Syrup (50 mg/5ml, pints)||Meperidine 8.24 gm|
|1 box x 100 gm Dextroamphetamine Sulfate powder||Dextroamphetamine 73.38 gm.|
|1 bottle x 500 Hydromorphone HCl tablets (4
|Hydromorphone 1.77 gm|
(9) Copy 3 of the Application for Permit to Export Controlled Substances for Subsequent Reexport (Form DEA 161R) is retained by the registrant.
PRIVACY ACT INFORMATION
AUTHORITY: Section 1003 of the Controlled Substances Act of 1970 (PL-513)
PURPOSE: Control exportation of certain Controlled Substances from the United States.
ROUTINE USES: The Controlled Substances Act Registration Records produces special reports as required for statistical analytical purposes. Disclosures of information from this system are made to the following categories of users for the purposed states:
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. Persons registered under the Controlled Substances Act (Public Law 91-513).
EFFECT: No permit will be issued.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a Collection of Information unless it displays a valid OMB control number. The valid OMB control number for this Information Collection is 1117-0004.