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DEA Registration Defense and Enforcement Actions Lawyers | DEA Registration Suspensions / Revocations Lawyers

March 21, 2024 Uncategorized

The DEA has a broad range of enforcement tools at its disposal, and it may use these tools to pursue both civil and criminal penalties. Civil penalties can include fines, asset forfeiture, and the suspension or revocation of a provider’s registration. Criminal penalties can include jail time, probation, and asset forfeiture.

If you are facing DEA enforcement actions or are under investigation for possible violations of the CSA, you should speak with an experienced attorney as soon as possible. The DEA can take many actions as penalties:

  • Suspend or revoke a registrant’s registration
  • Assess civil monetary penalties against a registrant
  • Refer the case to the U.S. Department of Justice for criminal prosecution
  • Deny an application for registration or renewal of registration
  • Refer the case to state licensing boards for disciplinary action against a registrant’s state license(s) to practice medicine, pharmacy, etc.

The DEA has a long history of aggressively pursuing enforcement actions against registrants who violate the CSA. In the past, the DEA has initiated enforcement actions against a wide range of registrants, including physicians, pharmacists, pharmacies, and pharmaceutical companies.

In addition to these traditional enforcement actions, the DEA has also initiated a number of compliance-related programs that are designed to help registrants comply with their obligations under the CSA. These programs include:

The Diversion Control Division’s Office of Diversion Control’s Compliance Program: The goal of this program is to help registrants comply with their obligations under the CSA and prevent diversion of controlled substances. The program includes educational materials and resources, as well as on-site visits by DEA Diversion Investigators.

The goal of this program is to help registrants comply with their obligations under the CSA and prevent diversion of controlled substances. The program includes educational materials and resources, as well as on-site visits by DEA Diversion Investigators. The Prescription Drug Monitoring Program: This program is designed to help state and local law enforcement agencies track controlled substances that are dispensed by pharmacies. The program includes a database that tracks controlled substances dispensed by pharmacies in each state.

This program is designed to help state and local law enforcement agencies track controlled substances that are dispensed by pharmacies. The program includes a database that tracks controlled substances dispensed by pharmacies in each state. The Office of Diversion Control’s Regulatory Compliance Unit: This unit provides regulatory guidance to registrants on how to comply with their obligations under the CSA. The unit also conducts audits and investigations of registrants who may be violating the CSA.

Controlled Substances Act (CSA) Overview

The CSA was enacted in 1970 to establish a comprehensive system for regulating controlled substances in the United States. The CSA establishes five schedules of controlled substances based on their potential for abuse and medical usefulness: Schedule I drugs have no accepted medical use but a high potential for abuse; Schedule II drugs have an accepted medical use but also a high potential for abuse; Schedule III drugs have an accepted medical use but a lower potential for abuse than Schedule I or II drugs; Schedule IV drugs have an accepted medical use but a lower potential for abuse than Schedule III drugs; and Schedule V drugs have an accepted medical use but a lower potential for abuse than Schedule IV drugs. The CSA requires that all providers who prescribe controlled substances be registered with the DEA to do so, and it requires that pharmacies that dispense controlled substances be licensed by state pharmacy boards as well as registered with the DEA to do so. The CSA prohibits anyone from distributing or dispensing controlled substances without being properly registered with the DEA to do so (21 U.S.C. 841(a)(1)). The CSA also prohibits anyone from distributing or dispensing controlled substances outside of legitimate medical purposes (21 U.S.C 841(a)(1)). Providers who prescribe medications outside of legitimate medical purposes may be charged with prescribing medication outside of legitimate medical purposes (21 U.S.C 841(a)(1)), while pharmacies that dispense medications outside of legitimate medical purposes may be charged with distributing medication outside of legitimate medical purposes (21 US Code 841(a)(1)). In addition to violating federal law, these activities may also violate state laws regarding prescription medications as well as professional licensing regulations regarding prescribing medications outside of legitimate medical purposes (21 USC 841(b)(1)(A)-(D)).

The CSA establishes strict recordkeeping requirements for providers who prescribe controlled substances and pharmacies that dispense them (21 USC 827). These requirements are designed to help ensure that providers only prescribe medications when they are needed for legitimate therapeutic purposes and that pharmacies only dispense them when they are prescribed by licensed practitioners acting within their scope of practice (21 USC 802). Providers who fail to maintain accurate records may be subject to civil penalties (21 USC 842(a)(4)), while pharmacies that fail to maintain accurate records may be subject to civil penalties (21 USC 842(c)(2)). In addition, both providers and pharmacies may be subject to criminal penalties if they knowingly distribute or dispense controlled substances outside of legitimate medical purposes (21 USC 841(b)(1)(A)-(D)).

DEA Enforcement Actions Against Providers & Pharmacies

The DEA has broad authority under the CSA to investigate suspected violations and take enforcement actions against providers who prescribe controlled substances outside of legitimate therapeutic purposes as well as pharmacies that distribute them outside of such purposes (21 USC 801-971). These actions can include civil penalties such as fines, asset forfeiture, suspension or revocation of registration, denial or restriction on registration renewal applications, orders restricting the distribution or dispensing of certain controlled substances by registrants whose registrations permit them to distribute or dispense those substances (e., orders limiting registrants’ authority), orders requiring registrants whose registrations permit them to distribute or dispense certain controlled substances not engaged in such activities until further order from the Administrator [of the Drug Enforcement Administration], orders requiring registrants whose registrations permit them engage in activities related only those locations specified in their registrations not engage in such activities at any other location until further order from the Administrator [of the Drug Enforcement Administration], orders prohibiting registrants from applying for any other registration until further order from the Administrator [of the Drug Enforcement Administration], orders imposing conditions on registrations permitting activities related only those locations specified in their registrations until further order from the Administrator [of]the Drug Enforcement Administration], orders imposing conditions on registrations permitting registrants engage in activities related only those locations specified in their registrations until further order from the Administrator [of]the Drug Enforcement Administration], denial applications seeking initial registration under this subchapter filed by applicants previously denied registration by final order issued after opportunity hearing held pursuant section 304[of Title 21], United States Code], denial applications seeking initial registration under this subchapter filed by applicants previously denied registration renewal pursuant section 304[of Title 21], United States Code].

The Registration Process for Controlled Substances

The registration process for controlled substances is complicated, and it can be difficult to understand what is required of a provider. The DEA has strict requirements for the registration process, and these requirements are constantly changing. A provider who does not keep up with these changes may find that their registration is denied or that they are unable to renew their registration.

Compliance with the Controlled Substances Act

In addition to the registration process, providers must also comply with the Controlled Substances Act (CSA). This act establishes schedules for controlled substances, which determine how these substances can be used and prescribed. Providers who do not comply with the CSA may face civil or criminal penalties.

If you are a provider of controlled substances and you have had your application for a certificate of registration denied by the DEA, or if you have been unable to renew your existing registration, you should contact an experienced attorney as soon as possible. At Spodek Law Group P.C., our attorneys have experience representing providers in matters involving DEA registrations and compliance with the CSA. We will work diligently to help you obtain or renew your certificate of registration so that you can continue providing care to your patients.

The Role of the DEA

The DEA is a federal law enforcement agency responsible for enforcing the Controlled Substances Act (CSA). The CSA regulates the manufacture, importation, possession, use, and distribution of certain drugs. The CSA gives the DEA the authority to register practitioners who are authorized to dispense controlled substances.

The DEA has strict requirements for registration and renewals. For example, a practitioner must have a valid state professional license to be eligible for registration with the DEA. Additionally, there are several other requirements that must be met before a practitioner can receive a DEA registration number. These include maintaining adequate security controls over controlled substances and ensuring that only authorized individuals have access to them.

If you are facing an investigation or inspection by the DEA or if your application for registration has been denied, it is important to seek legal representation as soon as possible. Our healthcare lawyers can help you navigate through this process and protect your interests throughout every step of your case.

The Controlled Substances Act (CSA)

The Controlled Substances Act (CSA) was enacted in 1970 and is the federal law that regulates controlled substances. The CSA establishes five schedules for controlled substances, which are based on the potential for abuse and medical use of the substance. Schedule I substances have a high potential for abuse and no accepted medical use, while Schedule V substances have a low potential for abuse and accepted medical uses.

The Voluntary Surrender of DEA Registration

The voluntary surrender of your DEA registration is an admission of guilt. You are admitting that you violated the Controlled Substances Act. The voluntary surrender is not a plea deal, and you are not pleading guilty to any criminal charges. The voluntary surrender is not an agreement with the DEA – it is a waiver of your rights.

Consequences of Voluntarily Surrendering DEA Registration

The first thing that happens when you voluntarily surrender your DEA registration is that you lose your ability to prescribe controlled substances. You can no longer write prescriptions for controlled substances – even if they are for legitimate medical purposes. This can cause serious harm to patients who need these medications and financial harm to healthcare providers who depend on their ability to prescribe controlled substances for their income and livelihoods.

In addition, the voluntary surrender of your DEA registration will appear on the National Practitioner Data Bank (NPDB). The NPDB is a database that all hospitals check before hiring healthcare providers – and many insurance companies check before approving claims submitted by healthcare providers. The NPDB will indicate that you voluntarily surrendered your DEA registration – which could make it difficult for you to find employment in the future as a healthcare provider.

The voluntary surrender of your DEA registration is also a permanent record. It will never go away. Even if you are able to get your DEA registration back, the voluntary surrender will still be on your record. This could make it difficult for you to find employment in the future as a healthcare provider – even if you are able to get your DEA registration back.

Changing Your Mind after Voluntarily Surrendering DEA Registration

If you voluntarily surrender your DEA registration and then change your mind, it is too late. Once you have signed the voluntary surrender form, there is no going back. You can never get your DEA registration back after voluntarily surrendering it. If you want to keep your DEA registration, do not sign the voluntary surrender form!

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Todd Spodek

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JEREMY FEIGENBAUM

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CLAIRE BANKS

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RAJESH BARUA

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