Compliance For Controlled Dangerous Substances

Controlled dangerous substances (CDS) have extremely strict compliance regulations due to the high potential of abuse associated with them. In fact, in 2024, Congress passed the MATE Act, requiring an additional eight hours of training for DEA-licensed practitioners to help them screen more people for substance use disorders, treat pain appropriately, prevent substance abuse, and engage in life-saving interventions.

Studies show medications of this category affect impoverished and disenfranchised communities the hardest due to increased odds of unemployment, minimal social support systems, and lack of healthcare. This can stress already overburdened staff at federally qualified health centers or behavioral health providers.

To maintain compliance, staff must complete specific training, adhere to strict policies, and obtain DEA (Drug Enforcement Agency) licensure for providers to prescribe controlled dangerous substances. Non-compliance with DEA regulations on controlled dangerous substances may face severe punishments, including fines, loss of licensure, remediation programs, and/or termination of employment.

In this blog, I’ll delve into what controlled substances are, federal and state compliance requirements, and how technology can simplify processes around CDS.

What Are Controlled Dangerous Substances?

Controlled substances are classified into five distinct categories, or schedules, depending on the drug’s acceptable medical use and its abuse or dependence potential. The rate of abuse is the main factor that determines what schedule a controlled substance will fall under.

This classification is mandated through the Controlled Substances Act. When the schedule number of a controlled substance increases, the lower the potential of abuse is related to said substance. Examples are:

Classification	Description	Examples
Schedule I	Drugs with no currently accepted medical use and a high potential for abuse	Heroin, Lysergic acid diethylamide (LSD), Peyote
Schedule II	Drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence	Methamphetamine, Methadone, Hydromorphone (Dilaudid), Adderall, Ritalin
Schedule III	Drugs with a moderate to low potential for physical and psychological dependence	Ketamine, Anabolic steroids, Testosterone, Tylenol (with codeine)
Schedule IV	Drugs with a low potential for abuse and low risk of dependence	Xanax, Soma, Valium, Ativan, Ambien, Tramadol
Schedule V	Drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics	Lomotil, Lyrica, Motofen, Robitussin AC

Meeting Compliance for Controlled Dangerous Substances

Many governing bodies play a pivotal role in ensuring compliance with daily operations in healthcare facilities around the globe. These organizations protect patient safety and help uphold the integrity of the healthcare system.

Federal Controlled Dangerous Substance Requirements

The DEA is a federal organization that enforces U.S. controlled substances laws. Any healthcare practitioner looking to prescribe controlled dangerous substances must obtain a DEA number, also called a license, from the U.S. Department of Justice Diversion Control Division.

A DEA license is a pivotal document for any medical practitioner’s career. Licensed providers can order, handle, dispense, and prescribe controlled dangerous substances. While DEA licenses give providers access to manage controlled substances, the license type will differ depending on the provider obtaining one. For example, pharmacists or doctors who work at hospitals, pharmacies, or clinics will have the letters A, B, F, or G as the first letter of their license number. This letter identifies the practitioner as a high-level practitioner.

Obtaining a license requires individuals to meet their state’s licensing requirements, which may include national standardized tests, law exams, hours worked as an intern, and more. After one meets the state’s licensing requirements, the next step is to apply for a DEA registration.

Assuring the accuracy of this process is paramount to prevent any delays in the application. Finally, after the fees are paid and the license is obtained, medical professionals must renew their license every three years. Practicing medicine with an expired DEA license may result in criminal charges or the loss of the privilege of practicing medicine.

Applying for a DEA license is only one of the hundreds of documents healthcare organizations and their providers must complete and maintain to manage controlled dangerous substances. DEA regulations differ from state to state. Here are a few more examples:

DEA Form 41: Involves the disposal or destruction of unwanted controlled substances. Depending on the healthcare setting, the definition of “unwanted”’ can include recalled medication, expired products, or broken/damaged medications.
DEA Form 106: Documentation on theft or loss reporting. Any loss or theft of controlled substances must be reported to the DEA.
DEA Form 222: Covers the ordering of Schedule I & Schedule II medications. Organizations must share these documents monthly with the DEA.

Failure to uphold compliance with these documents can result in multi-million-dollar fines, loss of DEA registration, and possible criminal convictions.

State-Controlled Dangerous Substance Requirements

Every state agency will have different regulations regarding controlled substance compliance. These rules dictate what’s required to handle, dispense, prescribe, and dispose of a CDS. It’s important to note that a DEA number does not mean you are free to manage CDS in your state.

In most cases, healthcare organizations and providers must obtain a DEA number and state certification. For example, in 27 states, only one license is required to order, handle, dispense, or prescribe controlled and non-controlled substances, while the remaining states require a separate CDS license.

Most states mandate annual renewal of CDS licenses. Your organization must submit a renewal application and associated fee to the appropriate state agency. Check your state’s requirements to ensure your facility and providers remain in good standing.

Use Technology To Streamline Controlled Dangerous Substances Compliance

With the complexity of controlled substance compliance, staying organized and having comprehensive tracking is paramount. A compliance platform offering a comprehensive variety of services in an all-in-one package can simplify monotonous tasks and heighten efficiency.

Complete Required Training

Proactive training for healthcare professionals at all levels empowers them to identify better, address, and prevent controlled dangerous substance abuse for patient populations most in need of intervention and treatment. Learning management systems simplify all aspects of training, including employee access, administrative oversight, and reporting. Choose a healthcare-specific LMS for the most courses that meet regulatory requirements and include the needed courses to satisfy MATE Act requirements. Look for topics such as hazardous drug risk assessment and how to create effective medication management systems.

Easily Accessible Documents and Policies

Ensure policies and procedures related to controlled dangerous substances are accessible by all staff. An online policy management system enables you to put all documentation — including manufacturer’s instructions for use — in one online location so employees don’t have to search or guess where the information might be kept.

License Verification and Exclusions Monitoring

Managing providers’ credentials is a complex task, especially when these providers are prescribing some of the most powerful and addictive drugs available. Simplify these tasks with automation in leading credentialing platforms, such as MedTrainer. The system automatically pulls DEA licenses into the platform to streamline your verification process. Automated reminders ensure you don’t miss expiration. Automated exclusions monitoring checks dozens of databases monthly and sends notifications if a provider’s status changes.

Interested in simplifying controlled substance compliance within your organization? See MedTrainer in action.