Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock continues to count down to the final compliance deadline. On August 25, , the U. Read our blog post here for all the details. If you want to ensure that your business processes comply with DSCSA pharmacy regulations, the first step is to familiarize yourself with the nuances of the law. The U. Drug Supply Chain Security Act , enacted on November 27, , establishes a system to track and trace prescription drugs in a fully serialized supply chain.
It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U. So far, the DSCSA has mostly focused on lot-level traceability β exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment will culminate next year with complete unit-level serialization of the U. This means stakeholders will have to electronically track products at the individual package level.
As the final link in the pharmaceutical supply chain, pharmacies are the last safeguard between suspect products and patients. They are responsible for gathering transaction information and reviewing supply chain data to verify the legitimacy of products more on that below. The DSCSA pharmacy requirements apply only to dispensers that provide medication to patients or end-users. If your pharmacy is providing medications to another dispenser or another member of the pharmaceutical supply chain, it is acting as a distributor, which means other DSCSA requirements would apply.
Failure to comply will raise flags with the FDA and open your organization to penalties, including fines. The purpose of these traceability requirements is to promote drug distribution security and to identify potential discrepancies in the supply chain records. Adhering to these transaction requirements will help pharmacies protect their consumers from illegitimate drug products. Traceability standards also help the FDA ensure that suspect prescription drugs do not enter the supply chain in the first place.
You can accept prescription drugs only if they have proper tracing information, and you must store the information for six years. You must also generate and provide all information when you sell a prescription drug to a trading partner. If information is missing, you will be found in violation of the DSCSA and could face substantial penalties. Providing product traceability information is another important part of DSCSA pharmacy requirements, as pharmacies frequently send inventory to other companies within their healthcare networks.
