New Arkansas PSE Law Limits OTC Sales to Arkansas Residents and Imposes New Duties on Pharmacists

By John A. Gilbert & Peter M. Jaensch –

Following what appears to have been the stall of the Arkansas prescription-only Pseudoephedrine bill (House Bill 1444) in mid-March, on March 23, 2011, Arkansas enacted a new law in the effort to combat illicit methamphetamine production.  Act 588 of the 2011 Regular Session (formerly Senate Bill 437, introduced by Senator Percy Malone (D)), primarily modifies several existing sections of the Arkansas Code applicable to products containing ephedrine (“EPH”), pseudoephedrine (“PSE”), and phenylpropanolamine (“PPA”) with regard to their status as controlled substances, sales limitations, acceptable forms of purchaser identification, and pharmacists’ duties.  Among these provisions, however, the Act imposes two new requirements, which are likely to create concerns.

First, the Act imposes a new requirement on pharmacists to “make a professional determination, based on a pharmacist-patient relationship, as to whether or not there is a legitimate medical and pharmaceutical need for the drug” before making any OTC dispensation of any non-exempt product containing EPH, PSE, or PPA.  The vagueness of the provision is likely to make implementation difficult.  The Act is silent as to what condition or circumstance should satisfy the dispensing pharmacist that the “medical and pharmaceutical need for the drug” is “legitimate.”  The Act offers pharmacists some guidance by enumerating several factors they may consider in making the required determination: (1) “Prior medication-filling history;” (2) “Patient screening; and” (3) “Other tools that provide professional reassurance to the pharmacist that a legitimate medical and pharmaceutical need exists.”  The Act also encourages pharmacists to err on the side of caution – that is, refusing to dispense – by providing that “[a] pharmacy or pharmacist is not civilly liable for a determination [of medical or pharmaceutical need]  or for any refusal to dispense, sell, transfer, or otherwise furnish ephedrine, pseudoephedrine, or phenylpropanolamine based on a determination of age or identity.”

Second, the Act makes it unlawful to dispense any product containing PSE, PPA, or EPH without a prescription, unless, among other requirements, the purchaser can provide an Arkansas-issued Driver’s License or ID card, or an identity card issued by the U.S. Department of Defense for active-duty military personnel.  Essentially, the Act permits Arkansas residents to obtain OTC products, but requires any out-of-state customer to obtain a prescription for the same product.  It seems likely that this provision is intended to make Arkansas pharmacies less attractive to smurfers in neighboring Mississippi, which is a prescription-only state for PSE products, without burdening Arkansans with a prescription requirement.

In summary, while existing law at the both the federal and state level would prohibit a pharmacy or pharmacist from knowingly selling these products above established limits or from selling these if there is reason to believe that it would be used for illicit purposes, the Arkansas law arguably goes further and requires the pharmacist to make a medical judgment on whether the patient has a medical need for the product.