DEA registration defense lawyers
Reasons To Have Legal Advice on DEA Registration
DEA registration defense is a mind-boggling legal minefield. Retaining an expert DEA defense lawyer is vital for physicians and pharmacists with a license to dispense highly regulated drugs, while strictly adhering to the guidelines of the Controlled Substances Act. CSA.
The inability to adhere to these guidelines can initiate a DEA legal action resulting in criminal, civil, and administrative sanctions. Non-expert legal representation during these proceedings can be disastrous and might lead to loss of registration, assets, business, licenses, and possible jail time.
Who is a Target?
DEA enforces compliance with CSA through periodic audits of physicians and pharmacies. Being the target of an audit means that the DEA has information about your activities, and the DEA prescription drug monitoring program has recommended an administrative inspection of your practice or drugstore.
Who Can Revoke My Registration?
DEA investigators cannot unilaterally revoke your registration during a DEA audit, or investigation, or by pressuring you to sign DEA Form 104. This can only happen after a lengthy procedure involving attorney representation, negotiations, and a court process culminating in a judge ruling which can be appealed to a Federal court.
Steps To Take During A DEA Investigation
Communicate Through Your Counsel
Experienced dea defense lawyers understand the inner workings of the DEA well enough to build a solid line of communication with DEA officials ensuring effective correspondence and feedback.
Your lawyer must handle all communications, and ensure all submitted documents are error-free to prevent future misunderstandings with the DEA.
Evaluate your practice
At Spodek Law Group , we understand the need for our clients to undertake self-assessment. And we help them prevent future DEA investigations by performing two key functions;
We defend clients by assuring the DEA that they are in compliance with CSA guidelines, and
We rectify any recurring issues ensuring clients develop processes that do not violate CSA regulations in the future.
How To Avoid DEA Attention.
The DEA initiates investigations based on data accrued from the prescription activities of medical practices and pharmacies. You can also develop an assessment process known as DEA Corrective Action Plan based on data obtained from your practice prescription activities to remain in compliance with DEA regulations.
What Is a Corrective Action Plan?
According to U.S.C. 824 (C) (2) (C), the DEA must evaluate a corrective action plan submitted by your lawyer before taking administrative action against your business.
A corrective action plan gives you a greater advantage when arguing your case before the DEA. It is proof indicating your intention to comply with DEA regulations, and in the event, administrative action has been taken; to convince the DEA administrator to retain your registration.
Vigorously Defend Allegations
Defend false allegations of violations of DEA regulations by developing an investigation plan providing irrefutable proof of your innocence at the DEA hearing, or a civil or criminal trial.
Prescription related cases require your lawyer to launch a thorough review of your practice, providing evidence showing your prescriptions are legally approved for use as required in medical professional practice
In dispensing related cases, dispensing records must be reviewed, and any documented issues linked with past prescriptions must be unearthed to use as proof of innocence. When armed with evidence supporting your innocence, be forceful in your defense in order to win an acquittal.
Important DEA Regulations
Security Requirements, 21 CFR 1301.71(a) and (b)
Suspicious Order Monitoring, 21 CFR 1301.74(b)
Theft and Loss, 21 CFR 1301.74(c)
Medical Necessity, 21 CFR 1306.04
Issuance of Prescriptions, 21 CFR 1306.05
Corresponding Responsibility, 21 CFR 1306.04(a)
Refilling of Prescriptions, 21 CFR 1306.22
Your Team for DEA Compliance and DEA Audit Defense
Spodek Law Group represent client interests during DEA actions against their practices such as; DEA raids, investigations, and audits. We handle your DEA registration applications and denials, defend your DEA registration suspension and revocation.
Spodek Law Group dea defense lawyers consult with clients on compliance with government regulations regarding highly regulated drugs. In the event of a client violation of the CSA, we create a line of communication with the DEA. And work on securing an agreement from both our client and the DEA, with the aim of resolving the case on terms favorable to the client.