Clarification of the Exemption of Sales by Retail Distributors of Pseudoephedrine and Phenylpropanolamine Products

By this interpretive rule, DEA is providing guidance to retail distributors for compliance with the law and DEA regulations regarding the exemption of sales of pseudoephedrine or phenylpropanolamine regulated products. Pseudoephedrine and phenylpropanolamine, which are regulated as List I chemicals, are components of many over-the-counter cold and allergy products. This rule does not change DEA's regulations and will have no impact on individual retail customers of such products who have been purchasing them from retailers which have been properly following DEA's regulations. DEA regulations already provide--and this rule clarifies--that an exemption from being a regulated transaction exists for sales of ordinary over-the-counter pseudoephedrine and phenylpropanolamine products ("safe harbor" products) by retail distributors. However, some sellers have failed to adequately understand that this exemption must be considered in the context of the definition of a "retail distributor." A retail distributor is one whose sales of regulated pseudoephedrine and phenylpropanolamine products are limited almost exclusively to quantities below the 9 gram threshold--whether these products are defined as "safe harbor" products or not--to individuals for legitimate medical use. Therefore, a person who sells more than an occasional amount of pseudoephedrine or phenylpropanolamine product at or above the 9 gram threshold for these products does not fit the definition of a retail distributor on which the exemption is based.