The Civil Controlled Substances Act (CSA) is a federal law that regulates drugs and other substances.
The law imposes stiff civil penalties for violations of its provisions and has been used to secure civil settlements and penalties that reach millions of dollars. If you or your company have been accused of violating the CSA, you could be facing substantial monetary fines that could have a crippling impact.
You have the right to a strong legal defense against allegations that you’ve violated the Controlled Substances Act. The dedicated attorneys of Griffin Durham Tanner & Clarkson are here to protect your rights and explain your legal options. As former federal prosecutors, we have deep experience handling CSA violations. We leverage our experience prosecuting some of the largest CSA cases in the country to help registrants respond when the Drug Enforcement Administration or Department of Justice calls.
What is the Controlled Substances Act?
Sometimes referred to as simply the CSA, the Controlled Substances Act is the federal government’s drug regulatory framework responsible for controlling the possession, manufacturing, use, and distribution of drugs and other substances.
The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for enforcing the CSA.
Legal and illegal drugs, both for medical and recreational use, fall under the CSA. It also applies to substances that are designed to mimic the effects of controlled substances and chemicals that are used to make controlled substances.
While the CSA is concerned with illicit drugs, a major aim of the law is to prevent the misuse of legal substances, such as prescription medications. To that end, the law created both registration and trafficking provisions.
We will focus primarily on the registration requirements of the CSA and how they may relate to you.
GA Controlled Substance Laws and Drug Schedules
In the state of Georgia, drugs are regulated through the Georgia Controlled Substances Act. When you violate the Georgia CSA, you could face both criminal charges that could deny your freedom and civil penalties that could empty your wallet.
The state of Georgia does not take violations of the CSA lightly, and violations are targeted with aggressive enforcement measures and punishments. You could receive a prison sentence in addition to tens of thousands in fines for the individual, and potentially millions in fines for companies.
CSA violations are not to be taken lightly, but they will vary in seriousness depending upon the substance and how it is scheduled.
The law establishes five schedules of controlled substances based on their medical utility and potential for abuse and dependence.
Drugs within the first schedule have a high potential for abuse and have no recognized or accepted medical use in the United States.
Drugs on the schedule I list include psychedelics like LSD, mescaline, and peyote, as well as stimulants and other drugs like ecstasy or GHB.
Schedule II drugs also have a high potential for abuse, and according to Georgia drug law can also lead to substantial or severe psychological or physical dependence. Some Schedule II drugs have accepted medical use in treatments or for certain conditions.
Drugs under the Schedule II list include cocaine, morphine, oxycodone, fentanyl, methadone, crack, and codeine.
Those drugs that are in the third schedule have a lesser likelihood of abuse and have accepted medical use. They have the potential for low to moderate psychological or physical dependence.
Drugs that are classified as Schedule III include ketamine, testosterone, and some anabolic steroids.
Schedule IV drugs are noted for their accepted medical use in treatments, as well as their low likelihood of abuse. This schedule of drugs can lead to light or limited physical or psychological dependence.
Schedule IV drugs include bromazepam, clonazepam, phenobarbital, and others.
The final schedule is Schedule V, which includes drugs with an accepted medical use for treatments. Schedule V drugs have a low potential for abuse and can lead to only limited psychological or physical dependence.
Compounds or mixtures that have a limited amount of lacosamide, pyrovalerone, codeine, opium, or other drugs are under Schedule V.
CSA Registration Rules
Registration provisions of the CSA impose rules on entities that regularly work with controlled substances. These rules aim to ensure that drugs are not diverted from their legitimate and intended use into the hands of individuals who misuse the drugs.
Registrants, therefore, risk severe monetary penalties for violating the CSA’s rules.
Because the CSA concerns such broad usage of drugs and controlled substances, many different entities and individuals fall under its jurisdiction. These companies and individuals must register with the DEA and prevent controlled substances from falling into the wrong hands or being abused.
Anyone who produces, distributes, or dispenses any controlled substances has to register with the DEA. That includes:
- Manufacturers and distributors of controlled substances, such as pharmaceutical companies
- Dispensers of controlled substances, including hospitals, pharmacies, and individual medical practitioners and pharmacists
- Treatment facilities, such as methadone clinics
What are the obligations of registrants?
To help prevent the abuse and misuse of controlled substances, the following duties are imposed upon registrants:
- Recordkeeping and reporting. Registrants must maintain detailed inventory and records related to every controlled substance they manufacture, receive, sell, deliver, or otherwise dispose of. They are also required to flag suspicious orders of controlled substances and notify the DEA accordingly.
- Inspections. The DEA has the right to periodically inspect the establishment of any registrant to ensure it is complying with the law.
- Security. Registrants must adopt adequate security measures to prevent theft and diversion of controlled substances. The regulations concern such matters as how controlled substances are to be stored and who has access to them.
- Quotas. Production quotas for certain drugs are imposed to ensure that excess amounts are not produced, since this can increase the risk of controlled substances being stolen or diverted. These oversupply limits also extend to the importation of certain controlled substances.
- Prescriptions. Certain controlled substances can only be distributed to the ultimate user (e.g. patient) pursuant to a valid prescription.
Penalties for Violating Registration Requirements
In addition to the criminal and civil penalties for violations of the CSA concerning possession, manufacture, distribution, and other factors, there are also penalties for violations of Georgia’s CSA registration requirements.
Working with an attorney during the foundation period of your business can help to ensure that your registration is processed accurately and effectively. Violations can be costly and expose you and your business to liability.
The amount of any fines that you are liable for, or alternatively, the amount of time that you are sentenced to in prison, will vary depending upon the circumstances of your violation.
Additionally, the way you argue your case will impact how the court approaches your sentence. Working with an experienced criminal attorney with a CSA violation practice in your area helps to ensure that the courts are approached effectively and correctly.
An experienced attorney with knowledge of your courts’ procedures and case precedents will support your case and your freedom.
A violation of the CSA registration requirement includes:
- A failure to maintain records
- A failure to detect or report suspicious orders
- Non-compliance with security requirements
- Dispensing controlled substances without necessary prescriptions
When violations of the CSA registration requirements have occurred, they generally are not targeted with criminal charges. However, if a CSA registration requirement violation is knowingly engaged in, you can be charged with a criminal offense.
When a violation of CSA registration requirements has been identified, the Department of Justice (DOJ) can bring criminal charges against both individuals and corporate registrations. The potential penalties for CSA registration violations vary depending upon the nature and severity of the offense. While fines are often assigned for violations of businesses, individual violations can lead to incarceration.
The first criminal offense for a CSA registration violation by an individual is punishable by a fine, or up to one year in prison.
Should a registered manufacturer or distributor of opioids knowingly commit a violation of CSA registration or reporting, they could be punished by a fine of up to $500,000 per violation. Examples of this include failing to report suspicious orders for opioids, or to maintain effective controls against the diversion of opioids.
The purpose of the Georgia CSA is to ensure that controlled substances and those that create and sell them are carefully regulated. It is essential that suspicious orders and potential violations are reported. Otherwise, criminal actors will continue to be able to divert opioids to improper populations.
Through the enforcement of reporting and registration requirements, individuals and businesses alike are being held accountable for their actions. Without an attorney to advocate for your interests if you are facing such a charge, the potential repercussions could be life-changing.
Examples of Civil Violations of the CSA
The DEA has aggressively pursued violators of the CSA by assessing major monetary penalties or negotiating settlements requiring violators to pay hundreds of thousands and sometimes millions of dollars.
For example, in 2021, the United States Attorney’s Office settled two investigations totaling $792,000 in civil penalties against MedMark Treatment Centers of Texas and Ascension Seton Medical Center-Austin, a hospital.
Between the two of these entities, the alleged violations included:
- Allowing non-medical staff to dispense controlled substances
- Failing to maintain complete and accurate records
- Failing to keep records in a readily retrievable manner
- Failing to adopt adequate security controls
- Failing to timely report theft or significant loss of controlled substances
In another case out of Michigan, McLaren Health Care Corporation settled – to the tune of $7,750,000 – allegations that it (and related entities) had:
- Dispensed controlled substances without written prescriptions
- Ignored numerous red flags indicating suspicious activities concerning controlled substances
- Violated recordkeeping and reporting requirements, including failure to notify the DEA of known employee theft of controlled substances.
Civil Penalties for Violating the CSA
In addition to the prospect of criminal penalties for the violation of the CSA, there are also potential civil penalties that you could be exposed to for such violations.
Within the context of civil CSA violation cases, the primary element of the civil penalty is monetary. If you are convicted of a CSA violation, you may also be liable for up to $25,000 in penalties for your violations. These costs can quickly multiply and become very substantial, underlining the importance of working with an attorney as soon as possible after you are aware of your case.
When you have violated the CSA, you could be liable for:
- A civil penalty of up to $25,000 for any individual who violates the CSA through select elements of the Act
- For other violations, the civil penalty is not to exceed $10,000
- In the case of a registered manufacturer or distributor of opioids, the civil penalty related to a variety of CSA violations is not to exceed $100,000
- Manufacturers, distributors, importers, or exporters who violate the CSA could be liable for a penalty of up to $500,000
- Parties found guilty of violations in terms of distribution, dispensing, or possession can face civil penalties of up to $1,000 per violation
It is important to understand that these penalties accrue per violation; it is not a single penalty that serves as an umbrella over all violations. You could be liable for civil penalties for each violation, depending on how the violation is defined.
The most common CSA violations are defined, by party, as:
- In terms of importers, exporters, manufacturers, or distributors, a violation is defined as each instance of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or distribute.
- For manufacturers or distributors of opioids, a penalty may be accrued each time there is a failure to maintain effective controls over the diversion of opioids, and suspicious orders were missed and/or delivered to the wrong party.
- When a retailer is distributing a drug directly to the consumer for personal use, each separate package, unit, or container that is sold in violation of the CSA is considered to be a separate violation.
Your party status and the specific violation or violations that you have been charged with will determine which penalties are applied in your case.
In addition to the costly civil penalties associated with CSA violations, when the violations are prosecuted by an indictment which alleges that the violation was knowingly committed, the person shall be sentenced to up to a year in prison in addition to or in lieu of the monetary penalty.
The fact that your financial stability and freedom could depend upon the outcome of your CSA violation case underlines the importance of approaching your case with the best possible argument in your favor.
Learning the law and how it applies to your violations is possible, but lawyers spend eight years in school, plus years learning a practice area before specializing in an area like CSA violations. Your local courts will have unique procedures, and the precedents or outcomes of past cases are also used to guide future outcomes.
The most effective way to ensure that you achieve the best outcome is by working with a CSA violation attorney who has a track record of winning CSA cases. Contacting an attorney as soon as possible after you are aware of your existing or pending case will support the construction of the best possible argument and defense on your behalf.
How can a Civil Controlled Substances Act attorney help?
If you or your organization has been accused of violating the CSA, it is imperative that you retain legal counsel immediately. A knowledgeable attorney can defend you against allegations or negotiate a settlement that may not require you to admit liability.
Your attorney will take the following steps:
- Review the allegations against you and explain your obligations under the law
- Discuss the evidence against you as well as rebut evidence
- Negotiate a settlement, where possible, which could save your organization significant sums in penalties
- Take your matter to trial if necessary and defend you in court
Contact Our Civil Controlled Substances Act Attorney
The CSA is a unique and complicated area of law, but our law firm has devoted its practice to protecting the rights of individuals, healthcare providers, companies, and others accused of wrongdoing.
Let us put our experience to work for you today. Contact Griffin Durham Tanner & Clarkson to schedule your consultation. Call (404) 891-9150 for Atlanta, and (912) 867-9140 for Savannah.