Understanding Controlled Substance Registrations And Laws

The Drug Enforcement Administration (DEA) is helping to fight the opioid crisis by revoking controlled substance registrations from pharmacies, pharmacists, and prescribers under 21 U.S.C. § 824. The DEA revived this practice in 2018. It allows them to prevent suspect pharmacists, pharmacies, and prescribers from dispensing or prescribing federally controlled substances. In order to avoid revocations and business shutdowns, it is important to understand the DEA’s authority and processes.

What authority does the DEA have?

If a manufacturer, distributor, or dispenser of controlled substances is in a state with a controlled substances registration, they must register with the state and the DEA. Registrations must be kept up-to-date, and any changes must be reported. The DEA, or the United States Attorney General, can revoke a controlled substance registration for the following reasons:

1. Some felony convictions related to controlled substances;
2. Falsifying fillings with the DEA;
3. A history of exclusion from participating in federal healthcare programs;
4. The revocation, suspension, or denial of a controlled substance registration from the state; and
5. Any action that would cause the controlled substance registration to be inconsistent with public interest.

There are some things that must be done in order for the revocation to be legal. First, the DEA must serve the entity in question with an order that states the cause of the revocation or suspension. This is known as an Order to Show Cause. It must provide a date for the healthcare entity to appear before the DEA no less than thirty days after it is given. This allows the manufacturer, distributor, or dispenser to develop a correction plan to solve the issue.

Red flags that may cause the DEA to revoke a registration

According to DEA-issued Orders to Show Cause given to Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy and Trinity Pharmacy, Inc. in 2015, there are some red flags the DEA could watch out for. In both of these instances, the actions taken by the pharmacies were not typical to how these entities regularly do business. For instance, the DEA noticed the following things:

1. Patients traveled unusually far distances to fill prescriptions;
2. Patients were paying in cash;
3. Prescriptions were made for “drug cocktails”;
4. Refills were given early; and
5. Duplicate or near-duplicate prescriptions were prescribed by a single doctor and filled by persons with the same last name and address.

You may be wondering what this means for you if you are a dispenser, distributor, or manufacturer. The DEA has the authority to look at your actions and issue an Order to Show Cause for the revocation of your controlled substance registration based on what they deem suspicious.

Imminent danger to the health or safety of the public

In the case of imminent danger to public health or safety, registration can be revoked without an Order to Show Cause. The Attorney General can revoke a controlled substance registration without such an Order under 21 U.S.C. § 824(c)(5). This is an extreme measure that is taken in the most dangerous cases.

Understanding the laws that protect patients and healthcare entities

For anyone in the drug supply chain, it is extremely important to understand how the chain works, the laws regarding controlled substances, and the governing bodies that regulate them. Doing this will help protect your patients and your business. Here are three of the most important laws you need to know.

The Controlled Substance Act (CSA)

This law, regulated by the DEA and enacted in 1970, covers the handling, storage, and distribution of controlled substances. Pharmacies must stay compliant with the CSA in many ways including the transfer, disposal, and secure storage of controlled substances. This law also pertains to proper inventory, record-keeping, ordering, and dispensing of these drugs.

The Drug Supply Chain Security Act (DSCSA)

This law was enacted in 2013 and is implemented by the FDA. It is responsible for keeping the drug supply chain safe in the United States. The law contains rules and requirements that all pharmacies must follow to protect patients. Under the DSCSA, pharmacies must:

• Confirm their licensing and registration;
• Store information tracing the movement of any prescription drugs; and
• Watch for and manage situations that include illegitimate or suspect drugs.

The Resource Conservation Recovery Act (RCRA)

Through the RCRA, the EPA handles the regulation of hazardous drug waste from transport and treatment to storage and disposal. Because of the evidence of pharmaceuticals in groundwater, drinking water, and surface water, pharmacies and other entities in the supply chain must stay compliant with this act.

Pharmacies must take steps in order to prevent waste from getting into the environment, identify hazardous waste, calculate the weight of the waste, and notify the EPA or the applicable state agency. Next, the pharmacy needs to manage the waste under the regulations per generator category and transport it properly. Finally, pharmacies are allowed to dispose of or recycle hazardous waste on-site as long as they follow regulations pertaining to this action.

Staying compliant with controlled substance laws

Knowing all of this is vital to running a pharmacy or other healthcare entity that handles controlled substances. There are some other things your business can do to stay compliant, including:

1. Regularly review your processes to make sure everything is up-to-date with the laws;
2. Make sure all of your employees are familiar with the steps they must take to stay compliant;
3. Have someone oversee compliance throughout your business;
4. If anyone breaks the law or rules within your business, deal with the situation promptly; and
5. Speak with a healthcare attorney for assistance. These professionals understand the laws related to running a business in the healthcare industry. They can work with you to develop a compliance program and advise you if anything happens with your employees.

Do you need the assistance of an experienced attorney?

If you would like to learn more about controlled substance regulations and laws, contact the Healthcare Team at Brown & Fortunato. Our attorneys have the experience and knowledge you need to stay compliant in an ever-changing industry. You can reach us at (833) 228-6300 or Send Us an Email today.