The United States Drug Enforcement Administration, known as the DEA, administers and enforces the Controlled Substances Act of 1970, known as the CSA. The Controlled Substances Act is contained in United States Code 21 U.S.C. § 801 and 21 U.S.C. § 824. The DEA maintains both law enforcement and administrative authority. On the administrative law side, the DEA requires registration of individuals and businesses that distribute, export, import, manufacture or prescribe substances listed in the Controlled Substances Act. The Drug Enforcement Administration administers and regulates the registration of these individuals and businesses, which are divided into two categories; Retail Registrants and Wholesale Registrants. There are approximately 1.5 million DEA Retail Registrants. The following Retail Registrant healthcare providers may require DEA registration: Clinics, Colleges and Universities, Doctors, Dentists, Hospitals, Nurse, Pharmacists, Physicians and Veterinarians. There are approximately 1.5 additional DEA Wholesale Registrants. The following Wholesale Registrants may require DEA registration: Analytical Labs, Distributors, Exporters, Importers, Manufacturers, Narcotics Treatment Programs, Pharmaceutical companies, Researchers and Reverse Distributors. A DEA Registration is alternatively known as a DEA Certificate of Registration or a DEA Registration Certificate.
An Administrative DEA investigation can result in a DEA Registrant Action Hearing, known as a DEA Show Cause Hearing. The results of a DEA Show Cause Hearing can include DEA Registration Suspension Order and a DEA Registration Revocation Order. A Show Cause Hearing is initiated pursuant to a DEA Administrative investigation. A DEA staff Attorney files a Registrant Action against a DEA Registrant. Alternatively, a Registrant Action is known as a DEA Show Cause Hearing, or DEA Order to Show Cause Hearing. A DEA Administrative Registrant Action proceeding is governed by United States Code of Federal Regulations 21 C.F.R. § 1301.31-1301.46 and 21 C.F.R. § 1316.41-1316.68.
Pursuant to 21 C.F.R. § 1301.43(a), the DEA registrant has only 30 days from receipt of the DEA Registrant Action to file a request for a DEA Administrative Hearing. A DEA Administrative Law Judge, or ALJ, employed by the DEA Office of Administrative Law Judges, or OALJ, presides over the case. DEA Show Cause Hearings are generally held in Arlington, Virginia (Washington, D.C.), or in locations in close proximity to the DEA Registrant. Many DEA Registrant Action Hearings are held in Boston, Massachusetts; Chicago, Illinois; Los Angeles, California; and Seattle, Washington.
If you are a healthcare provider in the United States facing a DEA Show Cause Hearing, DEA Registration Suspension Order or a DEA Registration Revocation Order, contact a DEA Show Cause Hearing Defense Attorney for representation.
DEA Registrant Action Defense Attorney
A Drug Enforcement Administration Show Cause Hearing is a traditional evidentiary Hearing. A DEA Registrant Action Hearing follows the traditional Federal Rules of Evidence and is conducted in accordance with the United States Administrative Procedure Act, or APA. The DEA staff attorney, employed by the Office of Chief Counsel’s Diversion and Regulatory Litigation Section, is there to represent the government and prosecute the alleged violations of the DEA Registrant. The DEA staff attorney will not provide any legal advice or assistance to a DEA Registrant. Furthermore, the Administrative Law Judge will also refrain from providing any legal advice or assistance to the DEA Registrant. Thus, a DEA Registrant facing a DEA Order to Show Cause Hearing should retain the services of a DEA Registration Defense Lawyer to represent their interest at a DEA Show Cause Hearing. There are several steps in a DEA Registrant Action:
Discovery: The Drug Enforcement Administration Staff Attorney will provide all of the evidence that the DEA will use against the DEA Registrant. The DEA Registrant must also provide a witness list, exhibit list and all evidence that he or she intends to use at the DEA Show Cause Hearing to the DEA Staff Attorney and Administrative Law Judge. This process is called discovery. Failure to provide discovery means that the ALJ could prohibit the use of the materials not provided at the Show Cause Hearing.
PreHearing Statement: The Administrative Law Judge will require a PreHearing Statement from both the DEA Staff Attorney and the DEA Registrant. The DEA will be required to submit their PreHearing Statement first, followed by the DEA Registrant. The PreHearing Statement must contain a discussion of the issues facing the DEA Registrant, a statement of facts and conclusions of law.
Motion for Summary Disposition: If the DEA Registrant’s state license to practice has been suspended or revoked, the DEA can file a Motion for Summary Disposition. If the DEA Registrant’s state license is no longer valid, technically the DEA Registrant is not entitled to hold a DEA Certificate of Registration. Thus, the Administrative Law Judge may grant the Motion for Summary Disposition.
PreHearing Conference: A PreHearing Conference will be conducted by the Administrative Law Judge pursuant to 21 C.F.R. § 1316.54. The PreHearing Conference may be in person or held via videoconference. The Administrative Law Judge will try to bring both sides to a Settlement. If the Settlement discussion fail, the Administrative Law Judge will set dates for the Show Cause Hearing, discovery cut off and filing of the Post Hearing Brief.
Settlement: It is often possible to reach a Settlement with the DEA. This is known as a DEA Administrative Memorandum of Agreement. A Settlement generally requires the DEA Registrant admit liability to one or more allegations and accept certain limitations and prohibitions on distribution, export, import, manufacture and prescription of controlled substances or business practices related to controlled substances.
Hearing: Drug Enforcement Administration Show Cause Hearings proceed according to the Administrative Procedure Act and the United States Code of Federal Regulations. Administrative DEA Hearings require adherence to the Federal Rules of Evidence. Both the DEA and DEA Registrant have the right to make opening statements, present witness testimony, present documentary evidence and make closing arguments. Each side also retains the right to cross examine the other party’s witnesses. A DEA Registrant should hire a DEA Registrant Action Attorney for representation in a DEA Show Cause Hearing to present their case and defend their DEA Registration Certificate.
Post Hearing Brief: After the conclusion of the Hearing, the DEA and the DEA Registrant can submit Post Hearing Briefs to the Administrative Law Judge. Pursuant to 21 C.F.R. § 1316.64(a), the Post Hearing Brief should contain proposed findings of fact and conclusions of law.
ALJ’s Recommended Decision: The Administrative Law Judge must issue a written, Recommended Decision, within a timely fashion, pursuant to 21 C.F.R. § 1316.65(a). The Recommended Decision must state the factual and legal reasons for the Administrative Law Judge’s findings. The decision is only recommended because in the Federal Administrative Law process, the final determination is made by the agency director, in this case the DEA Administrator or DEA Deputy Administrator. Both the DEA and the DEA Registrant can file exceptions to the ALJ’s Recommended Decision. Pursuant to 21 C.F.R. § 1316.66, Exceptions must be filed within 20 days of the date of the ALJ’s Recommended Decision. Exceptions can be filed to the Administrative Law Judge’s Recommended Decision or to the other party’s Post Hearing Brief, both of which the Administrative Law Judge is required to consider.
DEA Administrator’s Final Decision: The ALJ’s Recommended Decision is forwarded along with all case documents to the DEA Administrator. A DEA Deputy Administrator or DEA Administrator makes a Final Decision pursuant to 21 C.F.R. § 1301.46 and 21 C.F.R. § 1316.67. The DEA Administrator can adopt, modify or reject the ALJ’s Recommended Decision. The DEA Administrator’s Final Decision concludes the DEA Administrative Law Show Cause Hearing process.
Appeal to the United States Circuit Court of Appeals: The DEA Registrant reserves the right to appeal the DEA Administrator’s Final Decision to the United States Circuit Court of Appeals.
If you are facing a DEA Show Cause Hearing related to your DEA Registration Certificate, contact a DEA Registration Defense Lawyer for representation.
DEA Registration Defense Lawyer
There are a number of reasons why the DEA can issue an Order to Show Cause or impose an Interim Suspension Order. An Interim Suspension Order means that a DEA Registrant cannot engage in distributing, exporting, importing, manufacturing or prescribing any item governed by the Controlled Substances Act. DEA Registrants often commit the following violations of the United States Code of Federal Regulations and Drug Enforcement Administration’s Regulations:
Acts Against the Public Interest: Acts against the public interest constitute grounds for a DEA Registrant Action. Acts against the public interest can include Distribution of Illegal Steroids, Operation of a Pill Mill (pain management clinic), Operation of an Internet Pharmacy, Overprescribing Controlled Substances.
Exclusion From Federal Healthcare Programs Such as Medicaid and Medicare: If a DEA Registrant is placed on the Department of Health & Human Services Office of Inspector General’s Exclusion List, known as the HHS OIG Exclusion List, the DEA can initiate a Show Cause Hearing.
Felony Conviction Related to Controlled Substances, Drugs or Narcotics: Felony convictions that can result in a DEA Registrant Action include Possession of Narcotics, Drug Sales, Drug Trafficking and criminal offenses involving the use of drugs or alcohol.
Materially Falsifying a Registration Application: Materially falsifying a DEA Registration application will result in a DEA Show Cause Hearing against a DEA Registrant.
Misdemeanor Conviction Related to Controlled Substances, Drugs or Narcotics: Misdemeanor convictions that can result in a DEA Show Cause Hearing are Driving Under the Influence of Alcohol (DUI), Driving Under the Influence of Narcotics and Possession of Narcotics.
State License Discipline, Including State License Probation, Suspension or Revocation: Any disciplinary action undertaken by a state licensing agency, board, department or entity can result in a DEA Registrant Action Show Cause Hearing. DEA must show a nexus between the conduct that resulted in the state licensing discipline and the scope of the Controlled Substances Act.
If you are a DEA Registrant, contact a DEA Registrant Defense Attorney for representation in a DEA Registrant Action or DEA Show Cause Hearing.
DEA Administrative Investigation Defense Attorney
The Drug Enforcement Administration employs nearly 5,000 Special Agents and 5,000 civilian staff members, including Staff Attorneys under the Office of Chief Counsel’s Diversion and Regulatory Litigation Section. Founded in 1973, the DEA traditionally focused on investigation of the distribution and sales of Marijuana, Cocaine and Heroin. In the past decade, a new emphasis has been placed on prescription drug abuse and healthcare and medical providers prescribing vast quantities of prescription narcotics and steroids. Appalachia, South Florida and Southern California have high concentrations of prescription drug abuse.
Doctors and Physicians who operate pain management clinics are often targeted in DEA Enforcement Investigations. The DEA refers to many pain management clinics as Pill Mills. In a Pill Mill, a Doctor or Physician will provide minimal pain management consultation to a substantial number of patients and prescribe enormous quantities of pain medication; particularly Schedule II and Schedule III prescription narcotics.
Wholesale Distributors of prescription narcotics and steroids are also frequent targets of DEA Enforcement Investigations. These Wholesale Distributors are often known as Internet Pharmacies. An Internet Pharmacy generally involves a Cyber Doctor either proving no consultation or a minimal consultation to a patient. The patient then receives the prescription narcotics in the mail from the Internet Pharmacy. Federal law prohibits the purchase of controlled substances and steroids without a valid prescription. A prescription is not valid unless it is preceded by a consultation between the Physician and the patient. Federal law also prohibits a non DEA Registrant from importing drugs and narcotics under the Controlled Substances Act, as well as steroids into the United States.
If you are a DEA Registrant facing a DEA Registrant Action, contact a DEA Administrative Investigations Defense Lawyer for representation.
DEA Registrant Denial Appeal Attorney
DEA Administrative Memorandum of Agreement Lawyer
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