DEA Proposes to Regulate all Pseudoephedrine and Phenylpropanolamine TransactionsNovember 27, 2007
On November 20, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to remove the thresholds for distributing, importing, and exporting pseudoephedrine and phenylpropanolamine (“PPA”). In September 2007, DEA indicated in testimony before the Senate Finance Committee that the Agency was in the process of finalizing the proposal.
Both pseudoephedrine and PPA are “List I chemicals” under DEA’s regulations. A List 1 chemical is a chemical “that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the [Controlled Substances Act] and is important to the manufacture of a controlled substance.” Although pseudoephedrine and PPA have therapeutic uses in both Over-The-Counter (“OTC”) and prescription drug products, pseudoephedrine is a primary precursor used in the synthesis of methamphetamine (a Schedule II controlled substance) and methcathinone (a Schedule I controlled substance), and PPA is the primary precursor used in the synthesis of amphetamine (a Schedule II controlled substance). The Combat Methamphetamine Epidemic Act of 2005 banned over-the-counter sales of cold medicines containing pseudoephedrine and limited the sale of such drug products to “behind the counter” status. In November 2000, FDA issued a public health advisory concerning PPA and requested that all drug companies discontinue marketing products containing PPA due to risk of hemorrhagic stroke. Also, in December 2005, FDA published a proposal to categorize all OTC nasal decongestants and weight control drug products containing PPA as “non-monograph” (i.e., not generally recognized as being safe for human use).
Under DEA’s current regulations, single transactions or multiple transactions of pseudoephedrine and PPA in a calendar month to a single customer that equal or exceed established thresholds are regulated transactions that trigger reporting and recordkeeping requirements. The current pseudoephedrine threshold is 1 kilogram, and the threshold for PPA is 2.5 kilograms. Elimination of the pseudoephedrine and PPA thresholds will make any registrant manufacturing, distributing, importing, or exporting pseudoephedrine or PPA in any quantity as bulk chemicals or in OTC subject to reporting and recordkeeping requirements. Importers and distributors of prescription drug products containing these chemicals will also be subject to the recordkeeping and reporting requirements, however, exporters of prescription drug products will not be subject to quota requirements. DEA-registered importers will have to obtain import quotas from DEA.
DEA explains in the preamble to the proposed rule that removal of the thresholds is necessary to implement the requirement in the Combat Methamphetamine Epidemic Act of 2005 that the Agency set import and production quotas and to address diversion concerns. DEA has found evidence of diversion of pseudoephedrine and PPA, as well as ephedrine (a related List 1 chemical) in all drug product formulations, including liquid, non-liquid, and gel capsules. DEA removed the threshold for ephedrine in October 1994 (59 Fed. Reg. 51,365 (Oct. 11, 1994)).
Comments on DEA’s proposed rule are due by January 22, 2008.