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DEA Compliance and Defense for Labs and Pharmacies: Importing Drugs from China

At the moment, around 97% of all antibiotics in the U.S. are imported directly from China. Even most non-antibiotic medications are sent to the U.S. from China, which means that pharmacies and laboratories must rely on these Chinese imports for their businesses. The main issue that comes with relying on Chinese imports is that counterfeit medications are commonplace and difficult to avoid. As such, it’s essential that researchers, pharmacy owners, and pharmacists understand how to effectively stay away from dispensing counterfeit drugs. The DEA has created a set of guidelines that all pharmacies and labs must adhere to.

Laboratory and Pharmacy Obligations Pertaining to Medications Imported From China

All pharmacies and laboratories that operate in the U.S. need to follow basic rules and regulations pertaining to importing prescription medications from other countries. While these guidelines apply to all countries that the U.S. imports medications from, particular attention has been paid to China as a result of the increase in counterfeit medications from the country.

Along with the anti-diversion provisions found in the Controlled Substances Act and control laws for imports and exports, pharmacies and labs are also tasked with adhering to specific guidelines set by the DSCSA law that was passed in 2013. Although lesser known than the Controlled Substances Act, the DSCSA is centered around the drug supply chain.

At the moment, the U.S. government is taking strong measures to monitor prescription medication imports from China, which makes it easier for pharmacies and labs to comply with federal import regulations. However, certain medications have proven to be difficult to monitor, which include synthetic drugs, furanyl, and fentanyl. Because of the significant importance that the U.S. government has placed on these drugs and other opioids, any healthcare entities that the DEA and FBI suspect for accommodating opioid diversion or fraud are being heavily targeted.

George FernandezGeorge Fernandez
14:16 30 Apr 24
Excellent 10 out of 10, Helped resolve my case. Jeremy explained everything and made everything easy to understand.
21:33 24 Apr 24
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!
Yelva Saint-PreuxYelva Saint-Preux
19:26 19 Apr 24
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.
Katherine SunKatherine Sun
18:08 18 Apr 24
my lawyer is Alex Zhik. Efficient, patient and professional
Nun yaNun ya
17:48 18 Apr 24
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.
Keisha ParrisKeisha Parris
20:45 15 Mar 24
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.
Taïko BeautyTaïko Beauty
16:26 15 Mar 24
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!
K MarK Mar
01:37 25 Jan 24
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.

Even though the DEA, FBI, and DOJ look at all healthcare entities to make sure that illegal medications aren’t being distributed, they mainly focus on pharmacies and labs that interface with the public. Since these facilities are directly involved with importing medications from China, the government wants to make sure that the wider public is protected from gaining easy access to illegal drugs.

Keep in mind that pharmacies and labs are assessed by the federal government for different reasons. With laboratories, the main goal is to make sure that labs don’t import drugs that are marked for research only to sell them later on for some amount of commercial gain. When looking specifically at pharmacies, the main risks that each pharmacy must avoid include diverting illegal opioids drugs and not complying with the Drug Supply Chain Security Act.

One common thread between pharmacies and laboratories that’s being investigated involves parallel importation, which is a common problem that occurs when medications are delivered to the U.S. via numerous overseas transactions. It’s possible for these transactions to cover up the original source of the medication. In this particular situation, most pharmacies and labs are unaware of the issue but are still at risk of being implicated in import control violations as well as violations pertaining to the DSCSA and CSA laws.

How to Maintain Regulatory Compliance

There are several things that your pharmacy or lab can do to maintain regulatory compliance and make sure that your legal issues are minimized. First, it’s important that you understand all of these regulations and compliance obligations that your pharmacy/lab is expected to adhere to. As mentioned previously, there are several federal laws that focus on importing medications from other countries.

Once you understand which regulations your pharmacy or lab is expected to follow, it’s then highly recommended that you create a comprehensive compliance program that addresses all of the legal risks associated with importing medications. When this program has been developed, all that’s left is to implement these compliance measures and make sure that everyone at your pharmacy or lab follows them. These measures can include everything from using extensive drug investigation protocols to making sure that all imported drugs are dispensed lawfully.

How Pharmacies and Laboratories Should Respond to FBI or DEA When Contacted

In the event that you are ever contacted by the FBI or DEA in regards to how your pharmacy or lab distributes imported medications, it’s important that you answer any questions they have and fully cooperate with their demands. Even if you have a well-rounded compliance program in place, it’s still possible that mistakes will be made.

Keep in made that simple mistakes won’t be prosecuted. However, the DEA and FBI will still be tasked with conducting investigations, which can include full audits and inspections of your pharmacy/lab. Some of the things you should do when responding to the FBI or DEA include:

  • Be proactive during the investigative process
  • Hire a reputable federal defense counsel
  • Develop a strong defense strategy with your defense counsel
  • Complete a comprehensive internal assessment

If you require compliance representation for an investigation or audit that’s set to occur, contact Lawscape today at (888) 497-6627 to schedule a free consultation. We want to help you guide the investigation to a favorable outcome.

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