Are you worried about the risk of non-compliance and the costly penalties that come with it? If so, you’re not alone. Many businesses struggle to keep up with DSCSA regulations, which can lead to compliance issues and severe consequences.
The good news is, PRS and Advasur have developed a solution that can help. Our DSCSA360 program is designed to ensure that you meet all the necessary requirements to avoid penalties and maintain a strong reputation.
PRS and Advasur have partnered to provide DSCSA 360™. This program includes all of the below features and tools to enable your pharmacy for success:
Advasur has been at the forefront of Track & Trace requirements since the law’s creation. Like PRS, Advasur was built by pharmacists for pharmacists. Their ultimate goal is to provide a turn-key outsourced solution so you can focus your attention on the most important part of your job, your patients.
PRS is proud to partner with Advasur. Together, we have developed the most convenient and complete DSCSA solution at an affordable price.
*This product is endorsed by FPN and NCPA, representing over 15,000 Independent Pharmacies.
The DSCSA was passed in 2013 to create a federal track and trace program for prescription medicines in the United States. DSCSA aims to prevent, detect, and respond to suspect and illegitimate medication in the United States Supply Chain.
The law established a 10-year roadmap with enforcement and adaptations in 2015 and 2018 related to Product Tracing, Product identifiers, Authorized Trading Partners, and Verification. The last section of the law, Electronic Drug Distribution Security (EDDS), goes into effect on 11/27/2023. Among other things, EDDS directs all trading partners to have in place a secure, electronic, and interoperable system for the exchange of transaction documentation [transaction information (TI) and transaction statements (TS)] to enable the tracing of prescription medications.
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a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.
Standard Numerical Identifier
means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.
a product for which there is reason to believe that such product—
a product for which credible evidence shows that the product –
means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.
a statement, in paper or electronic form, that the entity transferring ownership in a transaction—
Authorized Trading Partners
Enhanced Drug Distribution Security
Ultimately a Pharmacy should already be compliant with Product Tracing, Product Identifier, Authorized Trading Partner, and Verification as described above, this includes making sure you:
If you are not sure if you are compliant, please give us a call.
Now is the time to start preparing for the Electronic Drug Distribution Security Requirements, this includes:
Absolutely not. Your wholesaler is unable to do the following…
PRS and Advasur can help with everything.
The FDA 8/25/2023 Guidance stated that the “FDA generally expects trading partners to have the systems and processes in place to meet these [EDDS] requirements as of November 27, 2023, we [FDA} recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time.”
FDA further states the Guidance “is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) [EDDS] of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”
Pharmacies must be in compliance with the existing DSCSA Requirements, including authorized trading partner, product identifier, product tracing, and verification sections currently in enforcement, and compliance with these elements is still required. These requirements will continue to be included in audits from the FDA, State Boards of Pharmacy, PBMs, and the DEA and are fully covered with the ADVASUR/PRS DSCSA 360™ Program.
The ADVASUR 360™ Solution and the PRS DRUGSUPPLYTrack™ SOPs are battle-tested via audits for the DSCSA requirements currently in full enforcement and upcoming EDDS requirements. Those Pharmacies that are using the programs are compliant and will continue to be compliant. Additionally, Advasur and PRS support your Pharmacy from when an inspector/auditor walks in the door until they leave the Pharmacy.
DSCSA service and solution leaders Advasur and PRS stand ready to serve dispenser pharmacies for full compliance with current and future DSCSA requirements with minimal disruption to business workflow operations and patient care.
The Drug Supply Chain Security Act (DSCSA) aims to protect the United States Drug Supply Chain from counterfeit and adulterated medication. The law was passed in 2013 and has been rolled out in phases since 2015, with the last phase becoming effective on 11/27/2023.
The Pharmacy requirements of DSCSA can be broken down into the five following areas:
The DSCSA regulations require all manufacturers, wholesalers, and dispensers (including pharmacies) to be compliant when there is a transaction related to a covered medication.
Currently, only prescriptions medication are covered by DSCSA, with the following exceptions:
Need additional information about this program or any other Pharmacy Compliance and Credentialing services or products? Contact our compliance specialists today. Our specialists can help you even if you are already working with another compliance program.