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 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.
The obligations of the pharmacy are elaborated as follows:
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.
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:
1. 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.
2. 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.
3. 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.
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