Prescribing/Dispensing “Outside the Usual Course of Professional Practice:” Trend, Coincidence or Passing Fancy?

We follow the civil settlements agreed to by the Drug Enforcement Administration (“DEA”) and registrants that are announced in press releases by U.S. Attorney’s Offices and DEA.  We were interested to observe what appeared to be a recurring theme running through four of the six settlements announced from November 24th through December 11th.  The recurrent theme was issuing or filling prescriptions for controlled substances, or ordering controlled substances, “outside the usual course of professional practice.”  We asked ourselves whether the theme was a trend, a coincidence or just a passing fancy.

Legal Points:

• For a controlled substance prescription to be effective, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. 21 C.F.R. § 1306.04(a).
• A prescription that is not issued in the usual course of professional practice or in legitimate and authorized research is not a prescription within the meaning of 21 U.S.C. § 829, and the person knowingly filling such a purported prescription, as well as the person issuing it, is subject to penalties. Id.
• Prescribing “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” Gulf Med Pharmacy; Decision and Order, 86 Fed. Reg. 72,694, 72,703 (Dec. 22, 2021).
• The presence of a red flag does not prohibit a pharmacist from filling a prescription, but “means the pharmacist must address and resolve, and … make a record of its resolution assuming it is resolvable. Id.
• The Department of Justice adjusted civil penalties under the Controlled Substances Act assessed after July 3, 2025, up to $19,246 (generally recordkeeping and reporting) and up to $82,950 (other prohibited activity). Civil Monetary Penalties Inflation Adjustments for 2025, 90 Fed. Reg. 29,445, 29,448 (July 3, 2025).

Three Physicians and a Hospital…

The first settlement, announced by U.S. Attorney’s Office, District of Colorado, press release on November 24th, involved three physicians at a hospital who wrote prescriptions “not issued for a legitimate medical purpose or were outside the usual course of professional practice.”  Doctors Sheryll Castro-Flores, Joseph Jimenez, and Douglas McFarland, and Mt. San Rafael Hospital and Rural Health Clinic, their employer in Trinidad, Colorado, agreed to pay a total of $650,000 under the Controlled Substances Act and damages under the False Claims Act for allegedly issuing invalid prescriptions between January 2016 and December 2023.  The physicians allegedly ignored red flags that indicated the prescriptions were “improper or unsafe” that included high daily opioid doses, dangerous drug combinations, signs of substance abuse, prolonged opioid use, cash payments despite insurance coverage, travelling long-distances to obtain prescriptions, and repeated early refills.

The government alleges that the hospital that employed the doctors “is also liable under the Controlled Substances Act for the illegal prescribing of its employees, and under the False Claims Act for causing claims for payment for these invalid prescriptions to be submitted to the government.”

The $650,000 aggregate penalty was allocated in the following manner:

• Drs. Castro-Flores and Jimenez-$112,500 each;
• Dr. MacFarland-$100,000; and
• •Mt. San Rafael Hospital-$325,000.

To prevent recurrence, the hospital issued new policies and implemented new protocols that disallowed prescribing opioids for chronic pain management and to ensure that opioid prescribing for acute and sub-acute pain is done safely and meets state guidelines.

Federal Court Permanently Prohibits a Pharmacist from Filling Prescriptions…

The Department of Justice announced via press release on December 10th that a federal court prohibited Nathaniel Esalomi from filling opioid and other controlled substance prescriptions.  In addition, the pharmacist had a civil penalty entered against him for $10,000 of a $500,000 suspended civil penalty.  Esalomi had owned and been the sole pharmacist at Apexx Pharmacy in Hudson, Florida, that was dissolved following a 2022 complaint and a temporary restraining order.  The government alleged that Esalomi unlawfully distributed “powerful” opioids when he filled prescriptions he knew were not valid.  He allegedly charged “dramatically inflated prices” to fill opioid prescriptions, accepted thousands of dollars in cash, instructed individuals to forge signatures and falsify addresses, and filled numerous prescriptions for deceased persons.  Esalomi agreed to a consent judgment to settle the allegations in the complaint.

Physician Alleged to Have Issued 1,400 Invalid Prescriptions Over Seven Years

According to the press release, also published on December 10th by the U.S. Attorney’s Office for the Eastern District of Washington, Dr. Duncan Lahtinen of Spokane, Washington, allegedly issued over 1,400 prescriptions to thirteen patients “that lacked legitimate medical purposes or were outside the usual course of his professional practice.”  Many of the prescriptions were issued in some combination of opioids, benzodiazepines, sedatives and carisoprodol.  What has been dubbed “the Holy Trinity,” is a combination of opioids, benzodiazepines and a muscle relaxant that DEA has alleged is never for legitimate medical purpose.  Lahtinen also allegedly failed to address numerous red flags of his patients’ substance abuse.  The press release noted that the Washington Department of Health sanctioned Lahtinen twice previously for improper controlled substance prescribing.  The matter was resolved with Lahtinen agreeing to pay $120,000, which equates to about $87.00.

Physician Ordered Controlled Substances “Outside the Course of Professional Practice”

Lastly, the U.S. Attorneys’ Office for the Eastern District of Oklahoma announced on December 11th that osteopath Jonathan Clark of Poteau, Oklahoma, agreed to pay $105,000 to resolve allegations that he ordered controlled substances “outside the usual course of professional practice.”  We are unclear precisely what “ordering outside the usual course of professional practice” meant.  Dr. Lahtinen also allegedly stored and dispensed controlled substances at an unregistered location and failed to maintain records documenting when they were received and dispensed.

“Outside the Usual Course of Professional Practice:” Trend, Coincidence or Passing Fancy?

We were struck that four of the last six DEA civil settlements involved prescribing, dispensing or ordering controlled substances “outside the usual course of professional practice.”  So we asked ourselves whether this theme was a becoming a trend?  Was it a coincidence?  Or was it a passing fancy soon to disappear?  To answer our questions we looked at reported civil settlements dating from the early 1990s to present.  We found that of the 432 reported settlements, 45 settlements involved allegations of issuing or filling prescriptions “outside the usual course of professional practice.”  One settlement involved a physician who allegedly dispensed “outside the course of professional practice,” and there was the recent settlement that alleged a doctor ordered controlled substances “outside the usual course of professional practice.”

We conclude that allegations that a physician issued prescriptions, or that a pharmacy filled prescriptions, “outside the usual course of professional practice” is neither a recent trend nor a passing fancy.  Rather, we believe that it is a coincidence that the most recent settlements involved allegations of prescribers and pharmacies acting “outside the course of professional practice.”