The purchase, use, and disposal of controlled substances is strictly regulated by state and federal governments. It is important that individuals and organizations dealing with controlled substances understand state laws regarding controlled substances, as well as fulfill federal Drug Enforcement Agency (DEA) registration requirements.
In this article, we answer frequently asked questions about controlled substance licensing requirements at the federal and state levels.
What is controlled substance registration? (State level)
Controlled substances refer to drugs or chemicals with the capacity to create addiction or habituation. The U.S. Drug Enforcement Agency (DEA) categorizes these substances into five groups referred to as Schedules according to their potential for abuse, addictive properties, and medical utility.
These substances are regulated under the federal Controlled Substances Act (CSA).
Individuals who prescribe, administer, order, or store controlled substances are often required to complete a controlled substance registration (CSR) at the state level.
The controlled substance registration with the state may also be required prior to applying for a federal DEA certificate.
The CSR registration requirement can apply to
- Professionals working with controlled substances, such as doctors, dentists, veterinarians, pharmacists, and researchers
- Facilities that deal in controlled substances, including pharmacies, wholesale drug distributors, clinics, labs, and drug manufacturers
What are the requirements for controlled substance registration? (State level)
Both the requirements and the registration process for CSR vary by state. In certain states, it might be necessary for an individual to hold a valid practitioner license (such as a physician or dentist license) within that state prior to applying for a controlled substance registration (CSR). For facilities, some states simply ask that the 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.
Terminology can also differ by state. For example, in Wyoming, the state refers to the requirement as “Controlled Substance Registration”. New Jersey uses the term “Controlled Dangerous Substance (C.D.S.) registration”, while Oklahoma uses the term “OBN (Oklahoma Bureau of Narcotics & Dangerous Drugs Control) registration”.
CSR requirements for facilities
If a facility stores or distributes controlled substances, many states will require that facility to 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 that the entity 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 — such as if a facility dispenses controlled substances via mail order or an online pharmacy — it may be subject to registration requirements in a new state.
Facilities that relocate or undergo a change in ownership after a CSR is issued, must generally apply for a new registration.
CSR 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 drug categories (schedules) can be dispensed, prescribed, or administered.
In addition to having a professional license, some states require healthcare professionals, medical professionals, and 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. This program is also called a “prescription drug monitoring program” (PDMP).
