A change in the Drug Enforcement Administration (DEA)’s 2022 Pharmacist’s Manual is creating confusion about dispensing of pseudoephedrine products.

Three key pharmacy groups—the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), and the National Association of Chain Drug Stores (NACDS)—sent a letter to Thomas W. Prevoznik, deputy assistant administrator, Office of Diversion Control Policy at the DEA, seeking clarification. The manual states that the federal daily sales quantity limit of 3.6 g applies when a pharmacist dispenses pseudoephedrine pursuant to a prescription that federally does not require a prescription.

In the letter, the pharmacy groups argued that it has been previously understood that the federal daily sales quantity limit does not apply when dispensing pseudoephedrine products pursuant to a prescription.

“It has been our understanding since the Combat Methamphetamine Epidemic Act (CMEA) passed into law over 15 years ago that the federal daily sales quantity limit does not apply when dispensing pseudoephedrine products pursuant to a prescription,” according to the letter. “Based on discussions among our different associations and DEA officials contemporary with the passing of the CMEA and DEA’s promulgation and finalizing of implementing regulations, it has been our understanding that any SLCP [scheduled listed chemical product] that is dispensed pursuant to a prescription order is not subject to any of the requirements of the CMEA, irrespective of whether the product is a legend drug under federal law. We believe that DEA’s apparent policy reversal, seemingly announced in 2022 version of the Pharmacist’s Manual, will cause great harm to patients that rely on pseudoephedrine products to treat chronic medical conditions.”

The pharmacy groups pointed out that those patients would have to make additional office visits to their prescribers for much more frequent prescriptions and much more frequent visits to their pharmacies to receive their pseudoephedrine medications. “Notably, this apparent policy change would likely provide little to no additional benefit, as we are not aware that patients taking pseudoephedrine products pursuant to a prescription, without a federal sales limit for the past 15 years, have been even a minor contributor to the problems of methamphetamine abuse, production, or diversion,” the letter added.

The NACDS specifically questioned the legality of the change, explaining, “Considering that sales of SLCPs pursuant to a prescription result from a professional evaluation and through a learned intermediary, we do not believe that these types of transactions could be construed as being with a ‘walk-in customer or in face-to-face transactions by direct sales.’ When a patient presents a prescription to a pharmacy for a SLCP, such as pseudoephedrine, they are not merely walking into the pharmacy to conduct a transaction upon their own accord. Rather, they are presenting to the pharmacist an order given to them from a prescriber that has conducted a medical examination and evaluation. Consequently, we do not believe that CMEA sales limits would apply in these circumstances.”

The letter goes on to say that since the CMEA does not apply to legend drugs, the pharmacy groups maintain that it should also not apply to nonlegend drugs that are dispensed under the same procedures as a legend drug, “which are more stringent than the requirements of the CMEA.”

“APhA, NACDS, and NCPA thank DEA for the consideration of our concerns about its apparent policy change announced in the 2022 version of its Pharmacist’s Manual,” the letter concluded. “We urge DEA to issue official guidance clarifying that the federal sales limits of the CMEA, including the federal daily sales quantity limit of 3.6 grams, does not apply when a pharmacist dispenses pursuant to a [pseudoephedrine] prescription…”

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