YOU MAY HAVE SEEN TODD SPODEK ON THE NETFLIX SHOW INVENTING ANNA
When you’re facing a federal issue, you need an attorney whose going to be available 24/7 to help you get the results and outcome you need. The value of working with the Spodek Law Group is that we treat each and every client like a member of our family.
Pharmacy DEA Compliance: Is Your Pharmacy DSCSA Compliant?
Expert Legal Professionals and Compliance with DSCSA Laws
Expert legal professionals can handle compliance issues related to the DSCSA laws. These obligations are directed at pharmacies, regardless of their size. The FDA has three main categories that deal with regulation of pharmacies. These categories are prevention, detection, and response.
Determining Pharmacy Compliance
Determining the compliance of the pharmacy is critical. The licensing status and registration of the pharmacy is a top concern. The FDA advises that pharmacies seek to understand the regulations in order to identify trading partners in manufacturing, packaging, and distribution who are improperly licensed or have not been registered.
Obligations of the Pharmacy
The obligations of the pharmacy are elaborated as follows:
The pharmacy should check the registration of manufacturers and repackaging partners with the FDA.
Review the wholesale distribution company and logistics providers, who are licensed through the FDA.
Ensure that all other pharmacy partners are licensed with the state licensing board.
Enforcement Enacted Through the DSCSA
The Drug Supply Chain Security Act, or DSCSA, was enacted into law in 2013, yet it remains relatively obscure even within the realm of pharmacy owners and pharmacists. This law can unleash DEA agents on the pharmacy to uncover wrongdoings that are suspected. It’s important to hire a team of legal professionals to mount an effective defense.
If you are looking for a lawyer that listens, is aggressive where needed, and holds his word above all else, Todd is the best pick. I had hired multiple attorneys prior to hiring the Spodek Group for a white collar case. The first thing that stood out to me was the cost, as anyone going through the process and dealing with the system, money was tight at that time - especially after hiring and firing multiple lawyers. The cost was not as high as others which was definitely a plus. Todd's intake process was also unlike other attorneys. He took the time to actually listen. He cared. He was trying to put himself in my shoes while I was explaining the situation to him and he really took the time to understand the whole situation. Other lawyers will give you 15 mins and send you a retainer agreement. Not Todd, I think he spent almost two hours with me as I was explaining everything.Not only was he great during the onboarding process, he was supportive and very informative through the entire plea process and eventually sentencing. After hiring him, I asked if I should hire a prison consultant, he told me to save my money as he would do everything they would. He was right and held up to his word. Later on I would hear from others that went with the prison consultants that they were a waste of money - I am glad I listened to Todd!When it came time for sentencing, two days prior to sentencing, the prosecutor tried increasing my proposed prison time by almost double - apparently a normal move. Todd and his team worked with me non-stop through the weekend prior to sentencing to ensure that I was not given additional prison time. Again, he took the time to listen and came up with a strategy to explain the case with great detail.Unfortunately, I did plead guilty as that was my best option. Todd and his whole team wrote up nearly 300 pages of a summary of what happened and why I should not be given prison time. If I breakdown the amount I spent with Todd versus the amount of work that I saw being done, I am shocked I was not charged four times as much. The other benefit was, a lot of criminal defense lawyers were just a single attorney with a paralegal or two. Todd had a team of people that I dealt with (5-7 people that I interacted with), but he was ALWAYS accessible. It would never take him more than an hour to reply unless he was in court.I was sentenced to prison and I was emotionally distraught. Todd and his team did whatever they could even after sentencing to make sure I was alright. He personally stayed in touch with my family to ensure I was doing alright and offered support to them. Most lawyers would consider the job complete at sentencing, not Todd.After prison, Todd still spent time with me to make sure I was on the right track and avoiding any potential risks in the future. He has also been giving advice on how to navigate probation etc and has not been looking at the clock for billing.Although I wish I had never been arrested in the first place, I am glad I had Todd and his team in my corner. Without them I likely would have had to spend a lot more time in prison than I did.Thank you, Todd, and the entire Spodek Law team, for helping turn what was a nightmare into a manageable situation!
I am immensely grateful to the entire team at Spodek Law Group for their unwavering dedication and exceptional expertise throughout my case. From our initial consultation to the final resolution, their professionalism and tireless advocacy made all the difference. Their strategic approach and attention to detail instilled confidence in me every step of the way.Thanks to their hard work and commitment, we achieved a truly favorable outcome that exceeded my expectations. Not only did they navigate the complexities of my case with precision, but they also provided invaluable support and guidance during what was undoubtedly a challenging time. I cannot recommend Spodek Law Group highly enough, especially attorneys Todd Spodek and Claire Banks; they are beacons of excellence in the legal profession.YSP.
Todd, Ralph and Alex are amazing. Helped my husband get from a double digit number with multiple charges to a single digit, by the time I blink he will be out. They very professional and help with all your needs. They dealt with my anxiety and worry very well and they understand that your family member needs to get home as soon as possible.
Believe every single review here about Alex Z!! From our initial consultation, it was evident that Alex possessed a profound understanding of criminal law and a fierce dedication to his clients rights. Throughout the entirety of my case, Alex exhibited unparalleled professionalism and unwavering commitment. What sets Alex apart is not only his legal expertise but also his genuine compassion for his clients. He took the time to thoroughly explain my case, alleviating any concerns I had along the way. His exact words were “I’m not worried about it”. His unwavering support and guidance were invaluable throughout the entire process. I am immensely grateful for Alex's exceptional legal representation and wholeheartedly recommend his services to anyone in need of a skilled criminal defense attorney. Alex Z is not just a lawyer; he is a beacon of hope for those navigating the complexities of the legal system. If you find yourself in need of a dedicated and competent legal advocate, look no further than Alex Z.
I don’t know where to start, I can write a novel about this firm, but one thing I will say is that having my best interest was their main priority since the beginning of my case which was back in Winter 2019. Miss Claire Banks, one of the best Attorneys in the firm represented me very well and was very professional, respectful, and truthful. Not once did she leave me in the dark, in fact she presented all options and routes that could possibly be considered for my case and she reinsured me that no matter what I decided to do, her and the team will have my back and that’s exactly what happened. Not only will I be liberated from this case, also, I will enjoy my freedom and continue to be a mother to my first born son and will have no restrictions with accomplishing my goals in life. Now that’s what I call victory!! I thank the Lord, My mother, Claire, and the Spodek team for standing by me and fighting with me. Words can’t describe how grateful I am to have the opportunity to work with this team. I’m very satisfied, very pleased with their performance, their hard work, and their diligence.Thank you team!
I recently had Spodek Law Group represent me for a legal matter in NYC and I am thoroughly impressed with their services.Alex Zhik secured the best possible outcome for my case.It was a seamless journey from the initial consultation to the resolution of my legal matter. From the moment I spoke to Todd about my case, his enthusiasm to help was evident, setting a positive tone for the entire experience. The efficiency and professionalism displayed by the team is commendable.A particularly noteworthy aspect of their service is their user-friendly portal to upload your documents/evidence. This not only simplified the process, but showcases their commitment to streamline the client experience.Lastly, in an industry where legal fees can often be a concern, I found their pricing to be very reasonable, making needing legal assistance feel accessible and stress-free.I am grateful for their support and wouldn't hesitate to turn to them again in the future.
Expert attorneys can make all the difference if you are being put in one of these difficult situations. Your legal team can handle any encounters with DSCSA agents while protecting your legal rights in the process. This is an important consideration because the DEA agents can expertly leverage your fears and use them against your company. Typically, the agents arrive at a location, and they might not even have a warrant. They seek to use anything you do or say to justify more investigations. Protect your interests in this regard by contacting our law firm as soon as possible.
DSCSA and Prescription Drug Providers
The DSCSA was enacted by Congress in 2013 in response to the risks faced by patients who consumed counterfeit medications that were prescribed through a pharmacy. At the point the law was enacted, there was a great deal of concern about the consumption of counterfeit prescription medications. Compliance issues are a major concern for providers who might still be unfamiliar with these laws.
Federal resources have been disproportionately assigned to enforcement activities even when the concern about this issue dropped. The DEA and FDA aggressively pursue pharmacies to attempt to uncover compliance failures. There are obligations that pharmacy owners and pharmacists must follow; however, legal representation is critical to ensure that your rights are upheld even during this invasive process.
Consider the following advantages of gaining legal advice before proceeding:
Confirmation of protocols: Pharmacies are required to enact protocols that confirm registrations and licenses. This information can be acquired from the DEA and FDA. Legal assistance can help you to navigate this complex system of registrations and licenses.
Prescription medications reviewed for tracing information: Tracing data must follow the appropriate procedures for documentation. There are legal implications in the transaction in terms of its information, statement, and history. Legal services are useful for ensuring the requirements of the law are maintained.
Communication and documentation with partners: Trading partners must be carefully chosen to avoid any issues regarding the quality of the prescription drugs. Surviving a DEA inspection or audit can be stressful, and effective legal assistance can be invaluable when navigating this process.
There are many other areas where the legal team can assist in helping the healthcare organization surmount obstacles raised during a DEA investigation. The records need to be maintained for a specific period of time, under the DSCSA, for example. Compliance requires awareness of the law, and this is an ideal example of how legal assistance can become invaluable.
Other areas of concern may include the procedures used in the inspection of prescription medications, documentation, quarantine, and reporting. There are many details that are easy to overlook without the help of an effective legal team. Our law firm represents your position in the encounters with the DSCSA laws and enforcement agents. Our lawyers can advise you on matters of protocol, audits, inspections, and procedural issues. Contact our office if you have any concerns related to the DSCSA.
