As feared as the IRS is in the civilian world, there's an agency within the Department of Justice that is equally terrifying for healthcare and drug manufacturing companies, pharmacies, and even biotech and science labs that produce and control certain substances. This is the Drug Enforcement Agency or DEA. This law enforcement agency focuses solely on the war on drugs and prosecuting individuals or organizations guilty of violating the Controlled Substance Act (CSA).
What is the Controlled Substance Act?
The Controlled Substance Act is a set of statutes that covers nearly every area of handling, processing, or prescribing a controlled substance. The act breaks down the drugs into five categories or "schedules" — though that number could increase in the future. There are a variety of factors that determine the schedule. Below are some examples of each type.
Schedule 1 Drugs – Heroin, LSD, opioids, psilocybin and cannabis
Schedule 2 Drugs – Cocaine, fentanyl, methamphetamine, methadone, oxycodone
Schedule 3 Drugs – Ketamine and anabolic steroids
Schedule 4 Drugs – Xanax, valium, or any substance that can be used for legitimate medical treatment
Schedule 5 Drugs – These are substances with a limited use and are not available on the open market to the general public
Every person or entity that handles or prescribes drugs from Schedule 2 or higher must have a valid DEA maintaining registration. This includes dispensing and purity testing – even in very small amounts. Scrutiny is very high here in New Jersey. If you want to know more about what is considered a controlled substance or you have additional questions about compliance laws, contact a New Jersey DEA defense lawyer right away.
What must I do to avoid DEA scrutiny?
It's more than just DEA registration. Even if you get everything in order and do exactly as you believe the New Jersey law prescribes, you may still face scrutiny and even potential criminal charges. These violations can happen anywhere and to any business that deals with controlled substances. We can represent you regardless of what you do for a living.
New Jersey DEA Process
One of the primary functions of the DEA is to register individuals and businesses. These regulations state that you must re-register with the DEA at least once every three years. You must provide extensive supporting documentation and background check information. If you fail a background check, you will have to explain why.
This sounds simple enough, but these laws are quite complex and even the smallest mistake here (or omission) can disqualify someone from handling controlled substances. You could, potentially, open yourself up to criminal charges, which is why it's important to consult with New Jersey DEA defense lawyers during this process, even if you believe there could be problems with your renewal.
There are significant risks in failing a DEA inspection, application process, or even a "routine" audit. Failure can mean that your DEA registration could be revoked or you may not even get an initial registration. Other penalties involve the loss of one's medical license, debarment from federal healthcare programs, criminal charges, possible civil fines and penalties, and even time spent behind bars. In most cases, it's what you don't know that can do the real damage.
How New Jersey DEA Lawyers Can Help – Medicine
The DEA is responsible for conducting inspections and audits of registered healthcare providers and pharmacies. In addition to the time spent on these reviews, there are several situations which trigger an investigation by the DEA. This could include a complaint filed by another medical professional, the United States Food and Drug Administration, the local state boards, the Internal Revenue Service, or even an insurance company administrator. These agencies will work together to investigate potential violations.
Situations that may trigger DEA investigation include:
- Requesting details about why a certain medicine was prescribed to a certain patient
- Allegations of malpractice or a wrongful death lawsuit
- Attempting to treat opioid dependency with other drugs
- Writing prescriptions of your own free will without the consent of a patient
- Failure to make use of adequate pain protocols
- Operating a pill mill
- Scheduling unnecessary follow-ups
- Giving out too many prescriptions
Another aspect unique to the state of New Jersey is that pharmacists are allowed to make recommendations to patients. These recommendations must pertain to the medications taken by the patient. While this is the law, it could raise the suspicions of federal agents and ultimately lead to a DEA investigation. If DEA agents come to your doorstep, you can claim your right to remain silent right away – and you should.
How New Jersey DEA Lawyers Can Help – Manufacture
In the United States, only the FDA has full authority to authorize permission for companies to manufacture certain prescription medications and prescription drugs. The FDA is able to shut down certain lines in doing so. However, it will make a recommendation to the DEA recommending certain sanctions against the company and the responsible party or parties.
This can result in:
- Suspension or complete loss of a DEA registration
- Continued inspections by either agency
- Loss of workers who could be prosecuted criminally for their involvement in an alleged crime
- Prosecution for employees
New Jersey DEA defense lawyers can provide you with the assistance you need to challenge these penalties. They focus primarily on warning letters and loss or surrender of a DEA registration.
We are the Spodek Law Group
One of the most valuable parts of our courtroom team is the ex-DEA specialist agents and consultants we have working for us. With over forty years of agency experience, these individuals have acquired the knowledge necessary to understand the DEA's specific policies and procedures in handling certain matters. Our attorneys will use this knowledge as corroborating evidence when filing motions and litigating various motions or hearings.
Spodek Law Group New Jersey DEA defense lawyers can challenge the release of a license on different grounds. This can include:
- Absence of a material decision
- Review the out-of-service request and relate to errors made by the plaintiff's agents
- Appointments
- General business program investigations
- Civil rights offenses
- Miscellaneous fraud
- Explaining what they state as manufactured information
One thing to note about DEA investigations and enforcement actions are that they are handled by an administrative law judge or a DOJ judge as well as what are known as interviewers. These hear the case but rarely provide the sentencer. This is important to remember because the U.S. Attorney's office assigns a considerable number of agents to these cases. Their dedication to these cases is how they get their names out there and get promoted.
Spodek Law Group attorneys will prepare the best appropriate defense for you and your business or help prevent a criminal or civil DEA matter by helping you be in full compliance. If you find yourself or your business in this situation, you need to get a New Jersey DEA defense attorney. Contact us today.
