OTC pseudoephedrine, PPA "ordinary" products subject to retail reporting threshold by DEA.

OTC PSEUDOEPHEDRINE, PPA "ORDINARY" PRODUCT RETAIL REPORTING THRESHOLD established under proposed implementing regulations to the Comprehensive Methamphetamine Control Act issued by the Drug Enforcement Administration and published in the Federal Register Oct. 7. Under the 1996 law, "ordinary" pseudoephedrine or phenylpropanolamine (PPA) products were exempt from the 24 g single transaction sales reporting trigger required for non-"ordinary" products. "Ordinary" products are defined in the act as those sold in packages not exceeding 3 g pseudoephedrine or PPA base and packaged in blister packs containing no more than two dosage units per blister.

The "requirement of registration is waived for any retail distributor whose activities...are limited to the distribution of below-threshold quantities" of pseudoephedrine, PPA or combination ephedrine product "in a single transaction...irrespective of whether the form of packaging of the product meets the definition of `ordinary over-the-counter pseudoephedrine or phenylpropanolamine product,'" the DEA proposal states. The reporting threshold for a single transaction is 24 g pseudoephedrine, PPA or ephedrine base, the reg continues. The act was passed to curb the illicit manufacture of methamphetamine using OTC ephedrine PPA products ("The Tan Sheet" Oct. 7, 1996, p. 4).

The "waiver of the registration applies, regardless of the form of packaging of the drug product, only to those retail distributors whose activities are restricted to below threshold transactions," the reg states. The waiver of registration and reporting requirements was made "due to the small size and face-to-face nature of the transactions and the limited future potential of diversion from this segment of the industry."

A retail distributor is defined under the act as a store, entity or person whose sales are limited "almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales."

The 1996 law allows DEA to establish a 24 g single-transaction limit on sales of "legitimate" products one year after enactment of the law if these products were found to be used for methamphetamine production in a "significant number of instances." DEA says pseudoephedrine was used in 422 of 879 methamphetamine labs seized by DEA in 1996, compared to 93 of 327 labs seized in 1995.

The proposed reg also would require single-entity and combo ephedrine drug products to be stocked behind the counter in the retail setting. Under a July 1995 proposed rule issued at the request of DEA, single-ingredient and combination ephedrine products would be banned from OTC sale ("The Tan Sheet" July 31, 1995, p. 1). Pending issuance of a final rule, two ephedrine-containing oral solid dosage products remain on the market: Bayer Consumer's Bronkaid Dual Action caplets and Whitehall-Robins' Primatene tablets.

For those distributors required to register with DEA, the reg also provides a temporary exemption from registration, "provided that the person submits a proper application for registration on or before" Dec. 3; "all other chemical control requirements...remain in full force and effect," the proposal adds. The temporary exemption from the registration requirement extends until DEA has approved or denied the application.

The regulation specifies that those who distribute product via mail-order to nonregulated persons (those who do not further distribute the product) are required to "file monthly reports of each such transaction." Transaction reports can be filed on paper -- or by electronic means, once approved -- and must be submitted by the fifteenth day of the month following the month the transaction took place. The reg outlines the information to be included in transaction reports.

Many such changes proposed in the regulation are "conforming amendments" because "many of the legislative details of the MCA are provided in sufficient detail to be self-implementing without any additional regulation," DEA says.

DEA also issued a final rule Oct. 7 providing a permanent exemption from registration for retail distributors of combo ephedrine products "who engage exclusively in sub-threshold transactions," or those under 24 g ephedrine per transaction. A temporary exemption was granted in a Feb. 10 interim rule ("The Tan Sheet" Feb. 17, In Brief).

The final rule notes that wholesalers remain subject to registration requirements. Several comments received by DEA claimed the registration requirement "does not apply to wholesale distributors that engage in only sub-threshold transactions of combination ephedrine products"; other comments maintain the exemption should apply to "distributions to the retail distributors by warehouses that are owned or operate by the owner of a retail chain," DEA says.

The meth control act specifically creates the category of "retail distributor" to protect "public access to the products at the retail level," DEA says, noting the thresholds for non-retail distributors is much larger (1 kg for combo ephedrine products and pseudoephedrine and 2.5 kg for PPA). It has been "DEA's experience that the most efficient and effective means to identify and control diversion from the retail and wholesale levels is through application of the controls at the wholesale level."