Legal Memorandum: Pseudoephedrine and Regulated Transactions

Issue: When do transactions involving pseudoephedrine constitute "regulated transactions?"

Area of Law: Healthcare & Pharmaceutical Law Compliance
Keywords: Pseudoephedrine; Regulated transactions; Suspicious transaction reporting requirement
Jurisdiction: Federal
Cited Cases: None
Cited Statutes: 21 U.S.C. § 830(b)(1)(A); 21 U.S.C. § 830 (a)(3); 21 C.F.R. § 1310.04 (f); 21 U.S.C. § 802(39)(A)
Date: 12/01/2001

           If a transaction is a "regulated transaction " then it is subject to the "suspicious transaction" reporting requirements of 21 U.S.C. § 830(b)(1)(A) and purchase identification requirement of 21 U.S.C. § 830 (a)(3).  The Attorney General has established a "threshold amount" for pseudoephedrine at one kilogram per customer per month.  21 C.F.R. § 1310.04 (f).  The only transactions that are regulated transactions are those made at or in excess of that cumulative monthly amount.  See 21 U.S.C. § 802(39)(A). 


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