Within a pharmacy, a pharmacist is reaching onto the shelf for a controlled substance
ComplianceFebruary 02, 2024

Controlled substance licensing requirements

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

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).

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What is the DEA registration requirement? (Federal level)

In addition to state requirements, individuals and facilities handling controlled substances have requirements at the federal level. To adhere to the requirements of the Controlled Substances Act (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. They are also obligated to maintain inventories and records, as well as safeguard the controlled substances.

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 Controlled Substances Act (CSA) mandates the DEA to uphold a "closed system" of controlled substance distribution. This entails registering individuals or entities engaged in manufacturing, distributing, dispensing, importing, exporting, or conducting research or chemical analysis involving controlled substances and listed chemicals. This system is designed to prevent unauthorized access to controlled substances by imposing safeguards. Registrants must implement measures to prevent diversion of these substances, thereby enhancing control over their distribution.

DEA registration and renewal can be completed online. The expiration date for DEA registration (for either individuals or facilities) varies according to when the initial registration was made, the type of business activity, and the drug schedule.

DEA training requirement

The Consolidated Appropriations Act of 2023 mandates that all "qualified practitioners" must undergo mandated training on substance use disorders before they can register. According to Section 1263(a), a "qualified practitioner" is defined as someone licensed under state law to prescribe controlled substances, excluding solely veterinarian practitioners.

This implies that all DEA-registered practitioners, excluding those who are solely veterinarians, must fulfill the training mandate. This encompasses a range of professionals such as physicians, mid-level practitioners, pharmacists registered as mid-level practitioners, naturopathic physicians, dentists, and optometrists, among others.

The confirmation of this one-time training requirement is not included in subsequent registration renewals.

Frequently asked questions regarding handling of controlled substances

What is the difference between the DEA and the CDS certificates?

CDS registration is a state requirement and handled by a state agency (for those states that have a controlled substance registration requirement), and DEA registration is handled at the federal level.

CDS stands for “controlled dangerous substance”. Some states refer to controlled substance registration (CSR) as “CDS registration”.

A business must verify the DEA and CDS/CSR 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/CSR requirements in these states.

Is a DEA registration required for each location?

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 DEA has issued a limited exemption for this requirement: If a practitioner is registered at one location but practices at others within the same state, they do not need an additional registration for any other location in that state where they solely prescribe controlled substances. Another exemption is also granted for DEA-registered veterinarian practitioners.

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.

For more information on CT Corporation services and how we can streamline your business licensing, please contact us.

Hans Howk
Manager, Content Management
Hans provides internal support to key members of the Business Licensing Team, assisting with understanding industry nuances, searching and synthesizing statutes and regulations relating to business law.
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