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The Spodek Law Group is one of the most successful law firms in the USA. Our success comes from the fact we are attentive to details, and take a very pragmatic approach to each and every single case. Our clients turn to us for realistic advice – so they can make the appropriate decisions they need to make personally. Our goal is to make sure your case ends in a positive outcome, not only personally – but for your family as well.

 



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.

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.


Charle Butler
Charle Butler
2021-03-12
I was hesitant to hire the Spodek Law Group. I read reviews and knew they have a great reputation. However, I thought I would spend money and not see or speak to my attorney. From the beginning to end of my case Todd and the entire staff were available and willing to help. We worked towards and end result that was way above my expectation and Todd delivered. I am forever grateful for patience and long days and night spent working on my case. Thanks Todd and the entire team!
Mesonista parsons
Mesonista parsons
2021-03-05
My attorney at Spodek was Abigail. She was very knowledgeable and helpful with all my questions and concerns, as well as responsive. Her fees are affordable and Abigail took the time to make sure I understood everything relating to my case. I highly recommend Abigail and will request her services in the future.
debabrata chakraborty
debabrata chakraborty
2021-03-03
Todd A Spodek is the experienced and best criminal lawyer at USA. He is very professional and always respond on time. Alex also very cooperative and always help me. They took care me and my problem like family member. I am 100% satisfied for their professional service. My result was unexpected and amazing. They dismissed my case. I am really grateful to them. I will recommend you to go there if you want to solve your problem. I wish all the best for them.
Asata Hendricks
Asata Hendricks
2021-03-02
Truly appreciate the work the guys did!. Exceptional team & I know they care about each and everyone of their clients. I am super thankful to be referred to Spodek Law Group and I am grateful Todd & Alex were able to work diligently to achieve an outcome I am pleased with. Despite COVID they stayed on top of things and kept me informed every step of the way. Very thankful.
Mike Moroff
Mike Moroff
2021-02-26
I'm very satisfied with the services rendered by Todd, Alex and Mary Lou. I whole heartedly recommend Spodek Law Group . I've worked with and have retained other attorneys in the past with Todd's firm being the cream of the crop for many reasons. A very serious legal matter was resolved after a year's hard work and effort. Todd expertly guided me through the process and was able to navigate and make the good journey bearable as well as successful. Mary Lou initially provided excellent assistance before referring my case to Todd. Alex's support was effective and timely. The customer portal (MyCase) is an invaluable communication tool that also kept track of my case. Various aspects of my case were explained and there were several options provided but I made the final decision of how the case would be handled. The legal fee was reasonable considering the effort and amount of work plus it was a flat fee regardless of the length of time required to conclude my case. Todd made himself available to me and we had many scheduled meetings to go over the progress and to discuss the next steps. I felt more confident after many discussions with him. You will not go wrong choosing Spodek Law Group for legal matters.
Josh Katz
Josh Katz
2021-02-24
Being that it was the first time that I was in need of an attorney, I was afraid and hesitant and knew I needed the absolute best. It is beyond understood why Spodek Law Group has a reputation of being the top, if not the best law firm in New York. Alex and Abigail were there every step of the way even at the most unconvenient hours. I could not have asked for more. They are extremely good at what they do and they delivered much much more than just winning my case. A big thank you to Alex and Abigail for all the guidance and counseling and their upmost loyal support that extended far more than just legally. If you need the absolute best than don't hesitate to hire Spodek Law Firm.
L.C.
L.C.
2021-02-24
I cannot tell you how thankful I am to Todd and Alex for their hard work and dedication to my case. I had never been in any trouble before but I had an unfortunate event occur and in the midst of COVID-19 at that therefore I knew I needed a team that was dedicated to my success. Today- my case has been finalized and I’m walking away with no record and can continue life as a mother and a Grad student worry free. I cannot express enough gratitude for their assistance.
AnnMarie Soliman
AnnMarie Soliman
2021-02-23
I received a summons and called Spodek law group for a free consultation. Alex took my call and was very quick and responsive. He was available anytime through multiple platforms and very reassuring when needed. They are extremely organized and thorough. They got my case dismissed! I’m very grateful. Thank you Alex and Todd!

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Spodek Law Group have offered me excellent support and advice thru a very difficult time. I feel I've dealt with someone who truly cares and wants the best outcome for you and yours. I'm extremely grateful for all the help Spodek Law Group has offered me. I can't recommend them enough.

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Spodek Law Group was incredibly professional and has given me the best advice I could wish for. They had been helpful and empathetic to my stressful situation. Would highly recommend Spodek Law Group to anyone I meet.

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Best service I ever had. Todd is absolutely class personified. You are in the safest hands with spodek. They have their clients interest in mind.

~ Francis Anim

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"Spodek Law Group have offered me excellent support and advice thru a very difficult time. I feel I've dealt with someone who truly cares and wants the best outcome for you and yours. I'm extremely grateful for all the help Spodek Law Group has offered me. I can't recommend them..."

David Bruce

"Spodek Law Group was incredibly professional and has given me the best advice I could wish for. They had been helpful and empathetic to my stressful situation. Would highly recommend Spodek Law Group to anyone I meet."

Rowlin Garcia

"Best service I ever had. Todd is absolutely class personified. You are in the safest hands with spodek. They have their clients interest in mind."

Francis Anim
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