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The FBI’s Roots/Rand Pharmacy Bust: Why It’s Important

A couple of weeks ago, LegitScript’s President appeared on CNN to discuss what the news station described as the “Feds’ Crackdown on Online Pharmacies.” As noted in the story, the search warrants:

… centered around two pharmacies, one in the Chicago suburb of Des Plaines, Illinois, and the other here in this small town south of Salt Lake City.

The CNN story identified pharmacist Kyle Rootsaert as the pharmacist and owner of both pharmacies, interchangeably known as “Roots Pharmacy” and “Rand Pharmacy” over the last couple of years. According to the search warrant, JRBHealth Internet pharmacy network websites such as your-rx.com (now defunct) were utilized to facilitate orders on these pharmacies’ behalf.

The FBI’s search warrant is a watershed event in online pharmacy regulation in the United States. Here’s why.

Historically, a number of rogue Internet pharmacy networks have sought to present their operations as legitimate, and evade scrutiny by the Drug Enforcement Agency, by only selling non-controlled prescription drugs prescribed by physicians who have never examined the patients in person. The federal Controlled Substances Act, which the DEA enforces, explicitly prohibits the sale of controlled substance prescription drugs prescribed in this way. However, the Food, Drug and Cosmetic Act (FDCA), which the FDA enforces, doesn’t contain explicit language about online prescriptions or consultations (or, explicitly define what constitutes a “valid” prescription.) Thus, rogue Internet pharmacy owners have tried to be strategic, only listing non-controlled substances like Soma, Viagra or tramadol, and claiming that they are acting within the bounds of the law.

What’s significant is, the execution of the search warrant against Roots and Rand pharmacies indicated that the federal government doesn’t buy that line of reasoning. Indeed, the search warrants were predicated on the legal theory that mass online consultations in lieu of physical examinations are not the basis for a legitimate prescription, and if drugs are knowingly dispensed on this basis, it is akin to simply selling drugs without a prescription at all, and thus constitutes the crime of “Misbranding” under federal law (that is, the drugs are officially considered “misbranded”).

Also relevant was the fact that the physician, Dr. William E. Morrow, was not licensed in the states where the patients ordering the drugs were located. In other words, the federal government looked to state regulations dictating where a physician, pharmacy and pharmacist must be licensed; in this case, the notion that the physician was practicing without a valid license in the state where the patient was located contributed to the legal theory of Misbranding, a federal crime.

In several respects, this is similar to the pre-Ryan Haight Act era, in which pharmacies and prescribing physicians argued that the Controlled Substances Act did not explicitly require that a prescription be based on a prior in-person examination, but the DEA was able to investigate, indict and prosecute those DEA registrants anyway. Internet drug dealers have responded to the Ryan Haight Act by peddling the few prescription drugs that are addictive but are not controlled substances (Soma, tramadol and fioricet, to name three). The Roots/Rand pharmacy search warrants suggest that this approach will ultimately not be considered legitimate and will not survive legal scrutiny.