Controlled Substances - Getting Started

Controlled Substances are drugs for which there is a potential for abuse/addiction. Controlled Substances are divided into Schedules I -V depending on their medical use in the United States and relative potential for abuse and dependence.

• Schedule I Controlled Substances currently have no accepted medical use and a high potential for abuse.
• Schedule II Controlled Substances have a currently accepted medical use but high potential for abuse.
• Schedule III – V Controlled Substances have medical use and lower potential for abuse than Schedule II substances.

Some prescription drugs are Controlled Substances. If you use Controlled Substances in research, then you must follow the rules for Controlled Substances to obtain them.

Yes, but you are required to obtain specific permits/licenses before you can procure controlled substances. In South Carolina, you are required to obtain a license from the U.S. Drug Enforcement Administration (DEA) and a registration with the South Carolina Department of Public Health (SC DPH).

Note: all individual investigators who use controlled substances in their research much obtain individual RESEARCH licenses—you may not distribute controlled substances to another investigator who does not have applicable licenses/permits for possessing that substance.

In addition, the Clemson’s Attending Veterinarian may NOT provide controlled substances to investigators.

The use of controlled substances is regulated by federal and state laws and regulations. The U.S. Department of Justice Drug Enforcement Agency (DEA) is the lead federal law enforcement agency responsible for enforcing these laws and regulations.

In South Carolina, the SC Department of Public Health (SC DPH) provides the oversight.

Both federal and state guidelines govern the responsible use of controlled substances in research, and the use of controlled substances by researchers requires registration and licensing at the federal and state levels.

If you currently have a federal DEA registration, you may transfer your registration by going to the U.S. DEA website and completing an address change request after first obtaining a South Carolina Controlled Substances Registration. (The addresses on the DEA and South Carolina registrations must match.)

Plan on weeks to months. The DEA and SC DPH must visit your facility prior to approval to verify the proper storage and access controls are in place. The timing will vary on how busy their agents are.

SC DPH requires an annual renewal by April 1 of each year, regardless of what month your registration is issued.

The DEA license requires renewal before the expiration date of the license.

Note that if you add a new controlled substance, you must amend both registrations with the updated information.

The fee for registration with DPH will be $125.

The fee for DEA is $296. You may qualify for a waiver of the fee, per regulations.

Please see the page for Controlled Substance Requirements to understand your documentation and reporting requirements.