| Requirement
|
List I
21 CFR § 1310.02 (a)
|
List II
21 CFR § 1310.02 (b)
|
Proof of Identity
21 U.S.C. § 830
(a)(3); 21 CFR § 1310.07
It is the duty of each regulated person who engages in a
regulated transaction to positively identify each party to the transaction. |
X |
X |
Records
21 U.S.C. § 830 (a);
21 CFR Part 1310
Each regulated person who engages in a regulated transaction
shall keep a readily retrievable record of the transaction. |
X |
X |
Reporting Suspicious
Orders 21 U.S.C. § 830
(b)(1); § 842
(a)(11); 21 CFR § 1310.05 (a)(1)
Each regulated person shall report any suspicious regulated
transaction. Additional information can be found in the report of the
Suspicious Orders Task Force. |
X |
X |
Registration
21 U.S.C. § 822; 21 CFR Part 1309
Every person who manufactures or distributes any List I chemical
shall obtain a registration. |
X |
|
Import/Export Notification
21 U.S.C. § 971 (a);
21 CFR Part 1313
Each regulated person who imports or exports a listed chemical in
greater than threshold quantities shall notify DEA not later than 15 days
before the transaction (unless DEA waives the 15 day requirement). |
X |
X |
Authorization of International
Transaction 21
U.S.C. §971 (d); 21 CFR §1313.32 and
§1300.02 (15)
A broker or trader located in the United States and participating
in a threshold shipment of a listed chemical across an international border,
other than a U.S. border, must notify DEA no later than 15 days prior to shipment. |
X |
X |
Security
21 U.S.C. § 823 (h);
21 CFR §
1309.71-73
Registrants must maintain effective controls to prevent
diversion. |
X |
|
Mail Order Reports
21 U.S.C. § 830 (b)(3)
Each regulated person who engages in a transaction with a
nonregulated person which involves drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine and who uses the Postal Service or any
private carrier shall report monthly. See 21 U.S.C. § 830 (b)(3)(A)
for exemptions |
X |
|
Other Recurring Reports
21 U.S.C. § 830; 21 CFR §
1310.05-06
Every registered manufacturer shall submit manufacturing,
inventory, and use data on an annual basis. For tableting and encapsulating
machines, each domestic sale and each importation shall be
reported. |
X |
|
