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

Chemical Handler's Manual

APPENDIX A – Abbreviated List of Legal Requirements Applying to Regulated Persons and Regulated Transactions

Requirements: List I List II
21 C.F.R. 1310.02(a) 21 C.F.R. 1310.02(b)
Advance Notice on Transshipments and In-Transit Shipments
21 U.S.C. § 971(a); 21 C.F.R. § 1313.31
A listed chemical that meets or exceeds the threshold imported into the United States for transshipment or transshipped within the United States for immediate exportation must be reported to the DEA no later than 15 days prior to the proposed date the chemical will transship or transfer through the United States.
     
Authorization of International Transaction
21 U.S.C. § 971(e); 21 C.F.R. §§ 1313.32 and 1300.02(b)
A broker or trader located in the United States and participating in a shipment of a listed chemical that meets or exceeds threshold amounts across an international border, other than a U.S. border, must notify the DEA no later than 15 days prior to shipment.
     
Import/Export Notification
21 U.S.C. § 971(a); 21 C.F.R. part 1313
Each regulated person who imports or exports a listed chemical that meets or exceeds threshold quantities shall notify the DEA not later than 15 days before the transaction (unless the DEA waives the 15 day requirement).
     
Mail-Order Reports
21 U.S.C. § 830 (b)(3) 21 C.F.R. § 1310.03(c)
Each regulated person who engages in a transaction with a non-regulated person or who engages in an export transaction which involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals) and who uses or attempts to use the Postal Service or any private or commercial carrier shall report monthly. See 21 U.S.C. § 830(b)(3)(D) for exemptions.
 
     
Other Required Reports
21 U.S.C. § 830; 21 C.F.R. § 1310.05-06
Every regulated bulk manufacturer shall submit manufacturing, inventory, and use data on an annual basis. For tableting and encapsulating machines, each domestic sale, each importation, and each exportation shall be reported.
     
Proof of Identity
21 U.S.C. § 830 (a)(3); 21 C.F.R. § 1310.07
It is the duty of each regulated person who engages in a regulated transaction to identify each party to the transaction.
     
Registration
21 U.S.C. §§ 822 and 957; 21 C.F.R. part 1309
Each person who manufactures, distributes, imports, or exports any List I Chemical shall obtain a registration.
 
     
Records
21 U.S.C. § 830 (a); 21 C.F.R. part 1310
Each regulated person who engages in a regulated transaction shall keep a readily retrievable record of the transaction for two years.
     
Reports of Certain Transactions
21 U.S.C. § 830 (b)(1); § 842 (a)(10); 21 C.F.R. § 1310.05(a)
Each regulated person shall report certain transactions, as stipulated in Section VI of this manual, under "What Must be Reported", to the Special Agent in Charge of the local DEA Divisional Office (APPENDIX P) for the area in which the regulated person making the report is located.
     
Security
21 U.S.C. § 823(h); 21 C.F.R. §§ 1309.71 – 1309.73
Regulated persons must maintain effective controls to prevent diversion.

AppendicesTable of Contents | Appendix B

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