Under federal law, all businesses that import, export, manufacture, or distribute controlled substances and all practitioners licensed to dispense, which includes administering or prescribing them, must register with the DEA. 21 U.S.C. 822(a) and 21 U.S.C. 957(a).

If the DEA finds a registrant has violated the Controlled Substances Act (CSA), it may issue an Order to Show Cause or Immediate Suspension Order. Orders to Show Cause and Immediate Suspension Orders are collectively known as "administrative actions."

Order to Show Cause (OTSC)

Under 21 U.S.C. 824(a), DEA, under authority granted by the Attorney General, may suspend or revoke a DEA registration upon finding that a registrant has:

  1. Materially falsified the application.
  2. Been convicted of a felony under the CSA or any other law of the United States, or of any state, relating to a controlled substance or a list I chemical.
  3. Had a state license or registration suspended, revoked, or denied by a competent state authority and is no longer authorized by state law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals, or has had a suspension, revocation, or denial of a registration recommended by competent state authority.
  4. Committed an act which would render DEA registration inconsistent with the public interest.
  5. Been excluded (or directed to be excluded) from participation in a Medicare or state health care program.

Before taking such action, DEA, under authority granted by the Attorney General, serves upon the registrant an order to show cause why the registration should not be denied, revoked, or suspended. 21 U.S.C. 824(c)(1) and 21 U.S.C. 824(c)(2).

Under 21 U.S.C. 824(c), when served an order to show cause, the applicant or registrant has the opportunity submit a corrective action plan. Upon review of the corrective action plan, DEA, under authority granted by the Attorney General, shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan.

Immediate Suspension Order (ISO)

DEA may suspend a registration in cases where there is "imminent danger to the public health or safety." 21 U.S.C. 824(d).

" 'Imminent danger to the public health or safety' means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations" under the CSA, "there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration." 21 U.S.C. 824(d)(2).