The purchase, use, and disposal of controlled substances is strictly regulated by the federal government and state governments.
These regulations require that individuals — such as physicians, dentists, and researchers — obtain a controlled substance registration (CSR). A CSR is also required for facilities that deal in controlled substances, including pharmacies, wholesale drug distributors, and drug manufacturers.
The registration process varies by state. Some states simply ask that a facility add a note to the license application stating that it will be dealing with controlled substances. Other states require facilities to complete a separate controlled substance registration alongside the facility license application.
In addition to fulfilling the federal Drug Enforcement Agency (DEA) registration requirement, it’s important that businesses impacted by these regulations understand individual state laws. In this article, we answer frequently asked questions about controlled substance registration at the federal and state levels.
What is a controlled substance?
A controlled substance is a drug or other substance, or chemical precursor, regulated under the Federal Controlled Substances Act and the California Uniform Controlled Substances Act to prevent illicit abuse.
What is the difference between the DEA and the CDS?
A federal DEA certificate is required for all qualified practitioners who write prescriptions for controlled substances.
However, many individual states also require a practitioner to hold a Controlled Dangerous Substances (CDS) certificate in addition to a DEA certificate.
What is the Controlled Substances Act of 1970?
The Controlled Substances Act (CSA) — Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 — is the federal drug policy that regulates the manufacture, importation, possession, use, and distribution of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other chemicals.
The CSA consolidates substances that were previously regulated under federal law into five schedules based on the substance’s use, potential for abuse, and safety or dependency liability. The DEA enforces the CSA both domestically and internationally.
To ensure compliance, individuals who order, handle, store, and distribute controlled substances must register with the DEA, maintain inventories and records, and ensure the security of the controlled substances.
What is the state registration requirement for controlled substances?
State requirements for controlled substance registration vary. Terminology can also differ by state. For example, in Wyoming, the state refers to the requirement as “Controlled Substance Registration”, whereas Oklahoma uses the term “Bureau of Narcotics & Dangerous Drugs Control”.
A business must verify the DEA and CDS requirements in the states where the practitioner will treat individuals. If the applicant holds certificates across state lines, the organization must also verify the DEA and CDS requirements in these states.
Below are the requirements for facilities and individuals.
Requirements for facilities
If an entity stores or distributes controlled substances, in many states it must obtain a controlled substance registration. These entities include pharmacies, drug distributors, and manufacturers, as well as laboratories, clinics, and research facilities.
A CSR is typically required in addition to facility licenses. In cases where both a facility license and CSR are required, some states require the entity to obtain the facility license first — other states allow applicants to obtain both at the same time.
If an organization stores or dispenses controlled substances in multiple states, additional registration may be needed. Even if the facility lacks a physical presence in the state, if the organization dispenses controlled substances via mail order or an online pharmacy, it may be subject to registration requirements in a new state.
Requirements for individuals
The DEA relies on state licensing boards to determine whether a practitioner is qualified to dispense, prescribe, or administer controlled substances. These boards also determine which schedules can be dispensed, prescribed, or administered.
In addition to professional licenses, some states require healthcare and medical professionals or individuals who handle controlled substances to complete a CSR.
In states that don’t have a separate CSR requirement, individuals who handle controlled substances may need to register with the state prescription monitoring program (PMP) so that the state can oversee prescription and dispensing activity and monitor for abuse.
What are DEA registration requirements for controlled substances?
The DEA requires a separate registration for each place of business or practice at a physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed.
The registration and renewal process can be completed online (effective May 22, 2022).
If a pharmacy intends to export controlled substances, it must fulfill a yearly exporter registration using DEA Form 225. The application processing period is typically 4-6 weeks and is subject to fees (averaging more than $1,500) and an annual renewal requirement.
What are the requirements for EMS to administer controlled substances?
Emergency medical services (EMS) organizations must register with the DEA to store, deliver, and receive controlled medications and administer them to patients en route to a medical facility. The registration can also be used to demonstrate that the organization is federally authorized to provide services in a state. A single registration covers each separate EMS facility in a state. (There is no need to apply for a new registration for each facility.)
To ensure compliance with federal law, an EMS organization must adhere to the following:
- Store controlled substances at a registered facility or designated vehicle.
- During delivery, the EMS organization with DEA registration must deliver the controlled substances to EMS.
- Maintain electronic or paper records of the controlled substances and store in a designated area.
CT can help
Outsourcing business registration and license research, applications, management, and renewals can help you take the pressure off internal resources. By working with a full-service management provider who specializes in the efficient processing of business licenses you can free up your staff to focus on high-value business activities while ensuring you keep up with changing compliance requirements.