Controlled Substance Registrations for Pharmaceutical Facilities

Learn about registration requirements for facilities that work with controlled substances.

About Registration

Prior to storing or distributing controlled substances, entities in many states must obtain a controlled substance registration. Although controlled substance registrations are a common requirement for pharmacies and drug distributors and manufacturers, some laboratories, clinics, and research facilities may also be required to hold a controlled substance registration.

Controlled substance registrations are commonly required in addition to pharmacy, drug distributor/wholesaler, or other pharmaceutical facility licenses. In cases where both a license and a controlled substance registration are required, some states require facilities to obtain the facility license before applying for a controlled substance registration, while others allow applicants to apply for both the license and a controlled substance registration concurrently.

Application requirements vary by state, but many controlled substance registration applications ask for:

• Business entity information
• Information about the individual or pharmacist with administrative/managerial responsibility for the facility
• Legal and disciplinary history for the key members of the entity
• Ownership and management information
• Which schedules of controlled substances the facility will deal with
• A copy of the operating license/permit of the facility
• A blueprint of the facility (usually for pharmacies)
• Articles of incorporation or certificate of authority for foreign entities
• A signed affidavit stating that the signator has paid all relevant taxes and meets all relevant educational, training, and experience requirements

Firms operating more than one facility within the same state usually need to obtain a controlled substance registration for each separate facility. Depending on the type of controlled substances and the services of the facility, a unique individual in responsible charge may need to be designated for each location. In the case of pharmacies, for instance, most states do not allow pharmacists to act as the pharmacist-in-charge for more than one location.

After meeting state-level registration and licensing requirements, entities that distribute, store, or manufacture controlled substances may also need to apply for a federal controlled substances registration with the Drug Enforcement Administration (DEA). Like most state-issued controlled substance registrations, entities with more than one facility will likely need to apply for separate DEA registrations for each location subject to the registration requirement.

Multi-State Registration

Storing or dispensing controlled substances in more than one state often triggers a number of additional registration requirements for pharmaceutical facilities. Even facilities without a physical presence in a state, such as mail order or internet pharmacies, may find themselves subject to registration requirements when they dispense controlled substances in a new state.

Before approaching the board of pharmacy to apply for a controlled substance registration, facilities may need to foreign qualify with the secretary of state depending on their business activities in the state. Certain facilities may also need to apply for an operating permit or license from the state’s board of pharmacy either before or in conjunction with the controlled substance registration filing.

In addition to licensing requirements, facilities expanding services to additional states often incur a tax liability in those states. State departments of revenue commonly require entities to register for corporate income tax, and for entities with employees in the state, withholding and unemployment insurance taxes.

Maintaining Compliance

Controlled substance registrations typically expire annually, although some states have biennial or triennial renewal periods. In order to maintain the good standing of your facility, a renewal application and fee must be submitted prior to the expiration date of the registration. Entities that operate multiple facilities will likely have more than one registration to renew, so it is important to carefully track when renewals must be filed for each facility location.

For entities with a presence in multiple states, this process becomes even more involved. In many cases, multi-state entities must keep up with controlled substance registration renewals and secretary of state annual report requirements in each state where a facility is located.

In addition to these structured renewal events, facilities must also report qualifying individual, ownership, location, and other entity information updates as they occur, and facilities planning to store or dispense controlled substances from an additional schedule may need to reapply entirely for a registration.

Keeping up with each state’s requirements, tracking renewals, and submitting the applications on time are critical to avoiding penalties. Dedicated compliance services and software can help you keep track of varying jurisdiction requirements and relevant updates to state laws.

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