State registration requirements
The requirements and the registration process for controlled substance registration 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 CSR.
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.”
The CSR registration 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
State controlled substance registration for facilities
If a facility stores or distributes controlled substances, many states require that facility to obtain a CSR. These entities include pharmacies, drug distributors, and manufacturers, as well as laboratories, clinics, and research facilities. Depending on the state, this may mean adding a note to the facility license application stating that it will be dealing with controlled substances, or completing a separate CSR alongside the facility license application.
A CSR is typically required in addition to facility licenses. In cases where both a facility license and CSR are needed, some states require that the entity obtain the facility license first. Other states allow applicants to obtain both at the same time.
Organizations that store or dispense controlled substances in multiple states may need to register in each state. 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 that state.
Facilities that relocate or undergo a change in ownership after a CSR is issued must generally apply for a new registration.
State controlled substance registration 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 obtain a separate state Controlled Substance Registration (CSR) or Controlled Dangerous Substances (CDS) permit before handling scheduled drugs or applying for federal DEA registration.
Regardless of whether a state requires a separate standalone CSR, practitioners who prescribe or dispense controlled substances are generally required to register with their state’s Prescription Drug Monitoring Program (PDMP or PMP). This electronic database allows the state to track prescribing and dispensing activity to monitor and prevent drug diversion and abuse.
Federal registration requirements (DEA)
In addition to state requirements, individuals and facilities handling controlled substances have requirements at the federal level. Though commonly referred to as a "DEA license," this authorization is formally a registration under the Controlled Substances Act (CSA).
The CSA, Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, governs the manufacture, importation, possession, use, and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other chemicals. Under the CSA, any individual or organization engaged in activities such as manufacturing, distributing, dispensing, importing, exporting, or conducting research or chemical analysis involving controlled substances and listed chemicals must register with the DEA. Registrants are also required to maintain inventories and records and safeguard controlled substances.
The CSA mandates the DEA to uphold a "closed system" of controlled substance distribution, requiring all individuals and entities involved in manufacturing, distributing, dispensing, importing, exporting, or conducting research involving controlled substances to register. This system is designed to prevent unauthorized access and diversion of controlled substances.
Registration is location specific
Federal law requires a separate DEA registration for each principal place of business or practice where controlled substances are manufactured, distributed, imported, exported, or dispensed (21 CFR §1301.12), rather than one registration per entity or individual.
DEA registration and renewal processes are managed online. The expiration date for DEA registration (for either individuals or facilities) varies according to when the initial registration was made and the type of business activity. Retail pharmacies, hospitals/clinics, practitioners, emergency medical services agencies, and teaching institutions operate on a 3-year renewal cycle (with an initial term of 28 to 39 months). Manufacturers, distributors, reverse distributors, researchers, analytical labs, importers, exporters, and narcotic treatment programs must renew annually.
MATE training requirement
DEA registrants are also subject to the following training requirement. Under the MATE Act (Medication Access and Training Expansion), physicians, residents, fellows, and other healthcare professionals who prescribe controlled substances must complete eight hours of training on treating and managing patients with opioid or other substance use disorders.
This requirement applies to all DEA-registered practitioners (excluding those whose practice is limited to veterinary medicine), and encompasses physicians, mid-level practitioners, pharmacists registered as mid-level practitioners, naturopathic physicians, dentists, and optometrists, among others. This is a one-time requirement and does not apply to subsequent renewals.
EMS requirements for administering controlled substances
Emergency medical services (EMS) organizations must register with the DEA to receive, store, deliver, and administer controlled medications. Under the Protecting Patient Access to Emergency Medications Act (PPAEMA), a registered EMS agency may obtain a single DEA registration for each state in which it administers controlled substances, rather than a separate registration for each location at which it operates within that state.
To ensure compliance with federal law, a registered EMS agency must adhere to the following:
- Store controlled substances at a registered location, a designated location, or in an EMS vehicle that is situated at a registered or designated location, or actively in use by the agency
- Deliver controlled substances from a registered location to an unregistered designated location only after notifying the DEA at least 30 days prior to the first delivery.
- Maintain records of each controlled substance administered, disposed of, or delivered, whether electronically or on paper, at each registered and designated location of the agency
CT Corporation 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.
For more information on CT Corporation services and how we can streamline your business licensing, please contact us.
