A Hudson, Florida, pharmacist has been prohibited from filling prescriptions for opioids and other controlled substances under a temporary restraining order (TRO) issued Aug. 2 by a federal district court (United States v. Esalomi, No. 8:22-cv-01725-TPB-JSS (M.D. Fla.)).

The case illustrates the scrutiny under which a pharmacist can come through investigations of prescribers suspected of violating Controlled Substance Act (CSA) requirements and through undercover investigations of the pharmacist’s transactions involving controlled substances.

Details of Complaint

A complaint for injunctive relief and civil penalties filed by the Department of Justice (DOJ) Aug. 1 in the U.S. District Court for the Middle District of Florida and unsealed Aug. 4 alleged that the pharmacist, Nathaniel Esalomi, “has both fueled and profited from the opioid epidemic by repeatedly dispensing powerful opioids prone to abuse in violation of the CSA through the guise of Apexx Pharmacy, which he owns and runs as the sole pharmacist.”

The government said that in transactions with undercover law enforcement officials, Esalomi “repeatedly filled prescriptions for controlled substances that he knew were not legitimate in exchange for cash” and “repeatedly filled prescriptions in the name of dead patients and falsely recorded that these patients were present in the pharmacy when the drugs were dispensed.”

Physician Investigation

According to the complaint, the investigation into Esalomi stemmed from a May 11 report of potentially fraudulent prescriptions for promethazine with codeine cough syrup, a Schedule I controlled substance, being filled at pharmacies in three Florida counties by “a known drug trafficker.” The purported prescriptions were issued by a Tampa area physician.

By the following month, law enforcement officials had learned that the physician “writes prescriptions in exchange for cash, charging $450 for an oxycodone prescription and $650 for a promethazine-codeine prescription.” The physician allegedly issued the purported prescriptions “based on the information provided on a driver’s license but without seeing or having a doctor-patient relationship with the person depicted in the license.”

Law enforcement officials then conducted two undercover transactions in which the physician “wrote more than a dozen prescriptions for controlled substances to individuals [that the physician] had never met or examined, based on nothing more than text message[s] containing images of the purported patients’ driver’s licenses,” according to the complaint. The physician allegedly provided the prescriptions “in exchange for thousands of dollars in cash."

Undercover Pharmacy Transactions

On July 7, according to the complaint, two undercover law enforcement officials took six of the prescriptions to Apexx Pharmacy to be filled. The prescriptions were for identical quantities of oxycodone 30 mg tablets, promethazine-codeine and suboxone.

“Esalomi filled these six prescriptions despite having actual knowledge or being willfully blind to the fact that they were not legitimate,” the complaint alleged.

Moreover, according to the DOJ, Esalomi attempted to conceal the illegitimate nature of the prescriptions by creating “four additional prescriptions for the noncontrolled substances azithromycin, docusate sodium (stool softener), cyclobenzaprine (muscle relaxant) and ibuprofen” — prescriptions that had not been issued by a physician but that Esalomi allegedly added to the order “to conceal the illegitimate prescriptions among prescriptions for medications subject to less law enforcement scrutiny.”

“The exceedingly high price that Esalomi charged for the prescriptions also demonstrates his knowledge that they were not legitimate,” the government also alleged. According to the DOJ, a person would be willing to pay the $650 that he allegedly charged for each 473 ml bottle of promethazine-codeine — far above the market price when the drug is dispensed for a legitimate purpose — only because the drug was not intended for a legitimate medical use, “such as having an expectation to ultimately sell the controlled substance on the street for a much higher price.”

Later that day, two other undercover law enforcement officers visited Apexx Pharmacy to fill other prescriptions written by the physician. The prescriptions were also for oxycodone 30 mg tablets and promethazine-codeine, according to the complaint. Once again, Esalomi allegedly filled the prescriptions.

During the visit, the DOJ reported, when one of the undercover officers, Joseph Pelz, provided a Massachusetts driver’s license, Esalomi requested a Florida address. In the presence of Esalomi, Pelz turned to the other undercover officer, Jason Gates, and asked if he could use the address shown on Gates’ undercover driver’s license. Pelz then filled out a patient form at the pharmacy counter in Esalomi’s presence using that address. “Esalomi knew that this was a ruse,” the DOJ alleged, “and stated, “Because of out-of-state, I will have problems.”

In fact, according to the DOJ, Esalomi’s request for Pelz to alter his address “was designed to evade law enforcement detection,” because the out-of-state address or customers traveling long distances to obtain controlled substance prescriptions “are well-known red flags that a prescription may not be legitimate,” and a prescription linked to an out-of-state address would be recorded in the Florida Electronic Online Reporting of Controlled Substances Evaluation (E-FORCSE) system and might be reviewed by law enforcement officials.

As during the first undercover visit that day, Esalomi allegedly again created additional prescriptions for the same four noncontrolled substances to each order as if they had been issued by the physician. Also, Esalomi allegedly once again charged “the excessive price” of $650 for each of the two bottles of promethazine-codeine.

When Gates produced “a stack of cash” and told Esalomi that he had only $1,650 rather than the total charge of $1,816 for his prescriptions, Esalomi allegedly accepted the $1,650, saying, “When you come back next time, you pay me … can I trust you?” Pelz and Gates returned on July 14 and paid Esalomi $180 for the prior transaction. Esalomi allegedly accepted the payment.

Also during the July 14 visit, the two undercover officials presented eight more prescriptions for promethazine-codeine and oxycodone written by the physician, none of which were for the two officers’ undercover identifies. Esalomi agreed to fill the prescriptions, and Pelz gave Esalomi four driver’s licenses corresponding to the individuals named on the prescriptions. Esalomi instructed Pelz to fill out patient forms for the prescriptions, instructing Pelz to forge the signature of each of the four purported patients on the forms.

When the two officials returned later that day to pick up the prescriptions, Esalomi told then that, because the four new patients did not have a history of filling controlled substance prescriptions in the Florida data monitoring program (PDMP), Esalomi would need to see the patients in the pharmacy.

The following day, Pelz and Gates returned to the pharmacy with additional undercover officers associated with the driver’s licenses that had been presented to Esalomi on July 14. Each of the additional officers filled out a patient form.

One of the additional officers used a Miami address. Esalomi said that the officer needed to use a local address, saying, “Miami is just too far for me.” Gates told the officer to use the address on Gates’s undercover license, and Esalomi allegedly approved the change. Esalomi also allegedly told the group that he needed telephone numbers from everyone and that having everyone use Gates’s phone number would be acceptable. The group then left the pharmacy.

Pelz and Gates returned about an hour later to pick up everyone’s prescriptions. Esalomi told them that the prescriptions would cost $3,632 — again charging the excessive price of $650 for the promethazine-codeine. Pelz paid Esalomi $3,640, and Esalomi then provided two bags to Gates. The bags contained four bottles each of the two controlled substances as well as four bottles each of the same noncontrolled substance medications, prescriptions for which Esalomi fraudulently created as though they had been prescribed by the same physician.

“The exchanges of illegitimate prescriptions for cash … were essentially drug deals, in violation of 21 U.S.C. §842(a)(1),” the DOJ alleged in the complaint.

Prescriptions Allegedly Filled for Deceased Patients

The government also alleged that Esalomi had filled prescriptions for at least three patients who were deceased at the time.

For example, according to the DOJ, one patient died on July 21, 2019, but between July 19, 2021, and July 21, 2022, Esalomi allegedly “filled at least 23 prescriptions for hydromorphone, 20 prescriptions for oxycodone, two prescriptions for alprazolam, and one prescription for promethazine with codeine syrup for [the patient]. Each time he filled the prescriptions, Esalomi falsely indicated that [the patient] came to the pharmacy in person.”

Esalomi was charged with three counts of violating the CSA (21 U.S.C. §842(a)(1), 21 U.S.C. §843(f)(1) and §882(a), and 21 U.S.C. §856).

Motion for TRO

In its motion for a TRO and preliminary injunction, also filed Aug. 1, the government told the court that the injunctive relief was needed “to immediately stop Esalomi’s illegal activity.”

The government also asked for the TRO to be granted without prior notice, saying that advance notice “would provide Esalomi an opportunity to conceal or destroy relevant evidence” in “a parallel criminal investigation.”

On Aug. 2, the court granted the TRO, setting an Aug. 16 expiration date for the order. On the government’s Aug. 14 motion, the court extended the TRO to Aug. 29, on which date the court further extended the TRO “until the motion for preliminary injunction can be heard and resolved by the court.”