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Labs and pharmacies take note, FDA announces regulation change

| May 5, 2021 | Diagnostic Testing And Reference Labs, Pharmacists And Pharmacies |

There are various regulations that help better ensure patient safety when compounding medications. Although mostly beneficial, these regulations can prove challenging for pharmacies as well as diagnostic testing and reference labs. The government will conduct audits to ensure compliance, and a failure to comply with these laws can result in serious allegations of wrongdoing and federal charges.

A changing landscape poses difficulty for labs and pharmacies

To make matters even worse for labs and pharmacies trying to navigate these rules, these laws and regulations often change. The United States Food and Drug Administration (FDA) recently announced changes that impact the compounding of certain products. The change likely impacted labs and pharmacies that specialize in compounding or repackaging medications. This could include those who help provide coverage for younger patients by diluting medications that do not yet have a version dedicated to pediatric needs. In another example, a lab or pharmacy may repackage a dialysis product into a smaller amount to provide an optimal dose for a pediatric patient.

Leadership can help reduce the risk of a violation

Labs and pharmacies can take a multipronged approach to address the potential for a violation. First, they can review their practices to make sure they comply with all applicable regulations. It is important to do this regularly since the regulations often change and are updated as noted above. Second, make changes whenever needed. When these internal audits result in information of a potential problem, address the problem. Finally, it is wise to take allegations of a violation seriously. These can come with stiff financial penalties and, depending on the details of the allegations, pose the possibility of criminal charges against individuals involved in the alleged infraction.

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