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DEA Registration for People Handling Controlled Substances

 Manufacturers, distributors and other entities in the supply chain handle the controlled substances much before they are prescribed, dispensed or administered. They also have to abide by the DEA regulations.


The United States is extremely concerned about maintaining proper use of controlled substances as they have a high potential for misuse, abuse and diversion. The Drug Enforcement Administration (DEA) is responsible for maintaining oversight and curbing such illegal activities under the Controlled Substances Act. The diversion DEA implements all aspects of the said regulation and ensures full compliance by the concerned entities at all times.

The regulations are not limited to only the healthcare professionals, hospitals and pharmacies that prescribe, administer or dispense these controlled substances. The rules extend to all stakeholders in the entire supply chain, which includes activities like manufacturing, distributing, reverse distributing, importing, exporting and so on. Similarly, it also encompasses researchers, analytical laboratories and even narcotics control programs.

All the above listed entities have to first register with the DEA before they can commence their operations. Form 225 is the mode of application for registration for all manufacturers, distributors, researchers, importers and exporters. Only those operating a narcotics treatment program (including compounders) have to register using the Form 363.

The requisite forms are available on the DEA website and can be completed online. Hard copies can be availed from the local DEA office.



The application fee also has to be paid while submitting the form which mostly stands non-refundable. All other rules also apply to these entities, just like healthcare providers and pharmacies:


  • A separate registration is required for each principal place of business or physical location where the controlled substances are manufactured, distributed, imported or exported by a person. However, the following locations shall be exempt subject to certain conditions –
  1. Warehouse where controlled substances are stored but not distributed directly from such warehouse to registered locations
  2. Office for soliciting sales and supervision activities, without displaying or distributing the controlled substances
  3. Freight forwarding facility that has been approved for transferring the controlled substances
  • The registration is required to be renewed periodically.
  • There are strict regulations pertaining to the storage and security of the controlled substances.
  • Access also has to be controlled and supervised at all times.
  • Records have to be maintained in tune with the regulatory requirements and kept available for perusal at all times.
  • Disposal of expired, extra or otherwise redundant drugs also has to be in line with the applicable regulations.


Moreover, the regulations list the activities pertaining to controlled substances by groups along with certain coincident activities that are permissible for the said group. Any person or entity that desires to engage in more than one group of independent activities (excluding the coincident ones) will have to obtain a separate registration for each group of activities.

When it comes to staying in compliance, engaging the services of a professional DEA compliance consultant – like Titan Group - can be a big boon!

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