The Civil Controlled Substances Act (CSA) is a federal law that regulates drugs and other substances. It is essentially the government’s drug policy and applies to drugs that are legal and illegal, medicinal and recreational. 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.
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. 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.
The law establishes five schedules of controlled substances based on their medical utility and potential for abuse and dependence. The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for enforcing the CSA. 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.
The CSA’s Registration Rules
Registration provisions of the CSA impose a number of rules on entities that regularly work with controlled substances. The aim of these rules is 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 a broad usage of drugs and controlled substances, there are a number of different entities and individuals who fall under its jurisdiction. These companies and individuals must register with the DEA and follow a number of rules to 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.
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. In 2021, for example, 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
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 rebutting 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. Call Griffin Durham Tanner & Clarkson to schedule your consultation.