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.
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.
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.
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:
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.