The Drug Supply Chain Security Act (DSCSA) is a new law that aims to enhance the traceability of prescription drugs in the United States. The law has specific requirements for wholesale distributors and dispensers. These requirements are designed to help prevent counterfeit and diverted drugs from entering the supply chain.
As a medical or dental professional, you may be wondering what the DSCSA means for you. Here is a brief overview of the law and its impact on your practice:
Serialization:The DSCSA requires that all prescription drugs be serialized, meaning that each drug will have a unique identifier. This identifier will be used to track the movement of drugs throughout the supply chain.
Electronic Pedigrees:The DSCSA also requires that electronic pedigrees be created for each serialized drug. A pedigree is a document that tracks the history of a drug, including where it was manufactured, where it was distributed, and who it was dispensed to.
Audits:The DSCSA requires that wholesale distributors and dispensers conduct regular audits to ensure compliance with the law. These audits will help to ensure that drugs are being properly serialized and that pedigrees are being created and maintained accurately.
The DSCSA is a complex law, but it is an important step in protecting patients from counterfeit and diverted drugs. If you are a medical or dental professional, you should be aware of the DSCSA and the requirements that it imposes. There are a number of resources available to help you understand the law and comply with its requirements.
Here are some resources that can help you understand the DSCSA:
FDA website:The FDA website has a wealth of information about the DSCSA, including the law's requirements, compliance resources, and frequently asked questions.
GS1: GS1 is a global standards organization that offers a variety of resources to help businesses comply with the DSCSA, including serialization and electronic pedigrees.
TraceLink: TraceLink is a leading provider of serialization and traceability solutions for the pharmaceutical industry. They offer a variety of resources to help businesses understand and comply with the DSCSA.
We hope this blog post has helped you understand the DSCSA and its impact on your practice. If you have any questions, please do not hesitate to contact SurgiMac. We are here to help you comply with the law and ensure the safety of your patients.
