Introduction: The Controlled Substances Act (“CSA”)

The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to those drugs that either administrative proceedings or Congress have designated as subject to control. The DEA is the main federal agency responsible for enforcing the CSA. The DEA is authorized to take administrative action against violating individuals and entities such as issuing warning letters, ordering suspensions, imposing fines, and demanding revocation of the entity´s license. If criminal activity is suspected, the DEA will get the Department of Justice (DOJ) involved.

In 2020, the Department of Justice (DOJ) announced that it would increase its enforcement efforts against pharmacies and pharmacists under the Controlled Substances Act (“CSA”) for violating their duty to ensure that opioids are only used for their intended purposes with intended persons. This article, drafted by the federal defense attorneys at Oberheiden, P.C., explains the DOJ´s position on opioid enforcement and recent federal investigations.

“The increase in federal investigations for opioid abuse has caused many pharmacies to receive federal subpoenas and/or civil investigative demands regarding their sales of opioids and controlled substances. To protect themselves, pharmacies should take care in ensuring that they have appropriate compliance procedures in place to prevent opioid diversion and that such compliance procedures are working effectively. Hiring experienced federal defense attorneys is the best defense against federal investigations.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

DEA and DOJ Coordinated Efforts

The DEA generally investigates suspected violations of the CSA including the following:

• Dispensing controlled substances to individuals without a prescription;
• Lack of strong controls in place regarding the opioid distribution process;
• Registration and reporting violations;
• Failing to maintain detailed records on individuals and employees;
• Failing to file suspicious reports with the government regarding certain orders;
• Noncompliance with enhanced standards for security under the CSA; and
• Other factors regarding dispensing opioids and controlled substances bearing on the pharmacist´s or pharmacy´s responsibilities.

While the above activities subject the individual or entity to DEA oversight, they are generally not criminal offenses. That said, if the DEA suspects that a violation was knowingly made, the DEA—in conjunction with the Department of Justice (DOJ)—may bring criminal charges.

With the DOJ, the DEA is focusing its efforts on the national opioid crisis. The DEA in late October 2021 announced the results of Operation “Dark HunTor,” a coordinated international effort to halt opioid trafficking on the Darknet. The operation resulted in 150 arrests worldwide and the seizure of over $31.6 million in cash and virtual currencies, including about 234 kilograms of drugs such as amphetamine, cocaine, opioids, ecstasy, fentanyl, oxycodone, hydrocodone, methamphetamine pills, and counterfeit medicine.

These agencies have broadened the scope of the CSA for pharmacies and pharmacists by establishing liability for failing to detect the warning signs of drug abuse or diversion. In the eyes of the DOJ, if the pharmacy or pharmacist fails to have procedures in place that detect opioid abuse or diversion or ignores obvious warning signs or red flags, then they may be liable for filling prescriptions that lack a legitimate purpose or that are written by prescribers not acting according to the standards of their professional practice.

DOJ Investigations to Combat Opioids

The DOJ´s Consumer Protection Branch is leading the effort in pursuing both criminal and civil actions against individuals and entities who are diverting or abusing opioids, taking advantage of the opioid crisis in the nation, or who are otherwise negligent or reckless in prescribing or delivering opioids. The DOJ has made it a priority to target various individuals and entities in the opioid supply chain, including distributors, manufacturers, pharmacies, pharmacists, and prescribers. Below are notable examples:

• In early February 2020, a federal court ordered a pharmacy in North Carolina and a pharmacist to pay $600,000 in civil penalties and to permanently cease dispensing opioids and other controlled substances. The pharmacist was also ordered to surrender his license to practice. The order cites Defendant’s failure for years in responding to red flags of drug diversion when filling prescriptions for controlled substances.
• In March 2020, a pharmacy from Georgia and its pharmacist agreed to settle charges with the DOJ for unlawfully dispensing thousands of illegitimate prescriptions for opioids and other controlled substances under the CSA. Defendants had allegedly ignored and failed to take action against numerous red flags, including prescriber and customer warning signs regarding opioid abuse, and therefore facilitated the opioid distribution process. The pharmacist and pharmacy agreed to a settlement of about $2.1 million in civil penalties.
• At the end of October 2020, the DOJ announced the global resolution of criminal and civil investigations regarding opioid manufacturer Purdue Pharma LP and civil settlements. The charges involved the abuse and diversion of prescription opioids. The DOJ obtained guilty pleas, a settlement of over $8 billion, and the dissolution of the company’s assets.

The DOJ will continue its aggressive stance under the CSA with the help of the DEA. Another area of concern for prescribers in telemedicine has gathered increased federal scrutiny due to COVID-19. Telemedicine presents unique risks. Prescribers cannot see their patients and are unable to physically evaluate their condition. The lack of face-to-face meetings makes it easier for criminals to conceal their identities and true intentions. Further, identity verification procedures are often less intense with telemedicine and tele-visits. To avoid unnecessary federal attention, many prescribers and entities have implemented comprehensive compliance programs that are designed to detect, mitigate, and monitor an entity´s operations for red flags.

Conclusion

The Department of Justice (DOJ) is committed now more than ever to holding pharmacies and pharmacists accountable for their roles in allegedly failing to take action to prevent illicit uses of opioids or for further facilitating the nation’s opioid crisis. In conjunction with the DEA, the DOJ has pursued an aggressive, broadened stance for failing to take care that opioids and other controlled substances are not being diverted for illegal purposes. Violations regarding the mishandling of opioids or failing to take care in the opioid distribution process can lead to serious penalties and even imprisonment terms. We can expect more federal investigations and indictments under the CSA. To prevent this from happening to you, retaining experienced federal defense attorneys is your best defense.