DSCSA Compliance Solution for Pharmacies
Simple DSCSA Compliance Software, Created by Pharmacists for Pharmacies
Managing DSCSA compliance manually is becoming increasingly difficult as FDA enforcement deadlines approach.
Pharmacies need reliable software for pharmacy DSCSA compliance to handle EPCIS data, product tracing,
verification workflows, and audit preparation without disrupting daily operations.
PRS Pharmacy Services and Advasur created DSCSA 360™ as a practical DSCSA track and trace solution for independent pharmacies, specialty pharmacies, and multi-location operations. Built specifically for pharmacies, the platform combines DSCSA software, SOPs, employee training, compliance guidance, and ongoing support in one centralized system.
Whether you need a pharmacy DSCSA requirements solution for EDDS preparation, transaction data organization, or audit readiness, DSCSA 360™ helps simplify compliance while reducing operational burden.
Stay Compliant with DSCSA Requirements
Without the Complexity
DSCSA regulations continue to evolve, creating operational and technical challenges for pharmacies nationwide. A reliable DSCSA compliance program helps pharmacies manage these requirements with less confusion, fewer manual processes, and stronger audit readiness.
Many Pharmacies Struggle With:
- Managing EPCIS transaction data
- Tracking authorized trading partners
- Monitoring product tracing records
- Identifying suspect products
- Preparing for audits and inspections
- Maintaining required documentation for six years
- Training employees on DSCSA procedures
- Responding to FDA requests within required timeframes
Trying to manage these requirements manually increases the risk of compliance gaps, missing documentation, workflow disruptions, and regulatory penalties.
DSCSA 360™ Helps Simplify Compliance Through:
- Centralized DSCSA compliance software
- Automated transaction data collection
- EPCIS management tools
- Built-in alerts and monitoring
- Pharmacy-specific SOPs
- Employee training resources
- Ongoing compliance support from pharmacy experts
Unlike generic compliance software, DSCSA 360™ was designed as a pharmacy DSCSA compliance program for pharmacy workflows and real-world operational challenges. For pharmacies looking for a DSCSA compliance program USA providers can rely on, DSCSA 360™ offers a practical drug supply chain compliance program built around day-to-day pharmacy operations.
DSCSA Compliance Deadlines for Pharmacies
The FDA has extended certain Enhanced Drug Distribution Security (EDDS) enforcement deadlines for pharmacies. However, pharmacies must still comply with existing DSCSA requirements currently under enforcement.
Important FDA Update on DSCSA Requirements for Large Pharmacies
Large pharmacies may qualify for additional time to implement EDDS requirements if they meet FDA exemption criteria. This extension allows pharmacies to improve workflows, onboard trading partners, and prepare for EPCIS compliance.
Authorized Trading Partners
Product Identifiers
Product Tracing
Verification Requirements
Important FDA Update on DSCSA Requirements for Small Pharmacies
The FDA is granting exemptions from certain DSCSA requirements of Section 582 for small dispensers (pharmacies) and their trading partners until November 27, 2026.
Authorized Trading Partners
Product Identifiers
Product Tracing
Verification Requirements
Struggling with DSCSA Compliance?
Managing DSCSA internally can create workflow issues, documentation gaps, and audit vulnerabilities. Many pharmacies lack the time and resources to manage evolving compliance requirements alone.
PRS Pharmacy Services and Advasur developed DSCSA 360™ to simplify compliance and reduce operational burden. Our team helps pharmacies implement compliant systems while staying focused on patient care.
All-in-One DSCSA Compliance Solution
DSCSA 360™ combines pharmacy compliance guidance, EPCIS transaction management, SOP support, employee training, and audit preparation into one centralized solution. Pharmacies receive hands-on support throughout implementation and ongoing compliance management.
The Program Helps Pharmacies:
- Manage EPCIS transaction data
- Maintain compliant SOPs
- Monitor trading partner credentials
- Identify suspect products
- Prepare for audits
- Train employees on DSCSA workflows
How DSCSA 360™ Software Simplifies Pharmacy Compliance
Most pharmacies do not fail DSCSA compliance because they ignore regulations. They struggle because the process is fragmented across multiple wholesalers, systems, portals, and paper records.
DSCSA 360™ helps pharmacies simplify compliance by centralizing critical tasks into one platform.
With DSCSA 360™, Pharmacies Can:
- Access EPCIS transaction data from multiple trading partners in one place
- Organize DSCSA records for faster audits
- Monitor missing or incorrect transaction information
- Receive automated compliance alerts
- Track trading partner licenses and credentials
- Train staff using pharmacy-specific workflows
- Reduce manual documentation processes
- Improve audit preparedness and operational consistency
This centralized approach helps pharmacies improve efficiency while reducing compliance risk.
DSCSA Compliance Steps for Pharmacies
DSCSA compliance requires pharmacies to follow specific operational, documentation, and verification procedures to meet FDA requirements.
The step-by-step process below shows how a pharmacy supply chain compliance solution can help pharmacies manage authorized trading partners, product tracing, EPCIS transaction data, employee training, and suspect product investigations before compliance deadlines arrive.
Confirm Your Authorized Trading Partners (ATPs)
Verify that every manufacturer, wholesaler, distributor, and third-party logistics provider your pharmacy works with qualifies as an Authorized Trading Partner. Keep updated copies of required licenses, registrations, and credentials so your pharmacy can prove compliance during audits.
Implement Product Identifier Verification
Check that covered prescription products include the required product identifier, including the NDC, serial number, lot number, and expiration date. A pharmacy track and trace compliance system helps your team review product identifiers at receiving and flag anything missing, incorrect, or suspicious.
Set Up EPCIS Transaction Data Management
Pharmacies need a reliable way to receive, store, and retrieve EPCIS transaction data from trading partners. DSCSA 360™ functions as an automated DSCSA tracking system that centralizes transaction records, supports faster request responses, and helps meet the DSCSA retention period more efficiently.
Establish Suspect and Illegitimate Product Procedures
Create clear procedures for identifying, quarantining, investigating, and documenting suspect or illegitimate products. Your team should know when to contact trading partners, when to notify the FDA, and how to maintain investigation records for future review.
Train Your Team and Document Everything
Employee training plays a major role in pharmacy compliance because every staff member involved in receiving, handling, or documenting product movement needs to understand their responsibilities. A pharmacy compliance workflow solution helps keep training records, SOPs, transaction data, ATP documents, and investigation records organized and audit-ready.
Following these five DSCSA compliance steps helps pharmacies build stronger workflows, reduce documentation gaps, and prepare for upcoming compliance deadlines.
Recordkeeping
Pharmacies must maintain DSCSA transaction records for at least six years. This includes transaction information, transaction statements, verification documentation, investigation records, and trading partner credentials. DSCSA 360™ centralizes these records in one secure system for easier retrieval and audit preparation.
Tracking and Tracing
Pharmacies must receive and maintain compliant transaction documentation before or at the time of delivery. This includes monitoring EPCIS transaction data, identifying missing transaction records, managing suspect transaction alerts, and tracking products throughout the supply chain. DSCSA 360™ helps pharmacies integrate tracking requirements across all authorized trading partners.
Security Measures
Pharmacies must have procedures for identifying, quarantining, and investigating suspect or illegitimate products. DSCSA 360™ supports these workflows with SOP templates, employee training, investigation documentation tools, alert systems, and audit support resources.
What Happens If Your Pharmacy Is Not DSCSA Compliant?
DSCSA non-compliance can create serious financial, operational, and legal risk for pharmacies. It can also affect patient safety, supply chain access, and the trust your trading partners place in your pharmacy.
Pharmacies that fail to meet DSCSA requirements may face FDA enforcement compliance actions, including warning letters, fines, product holds, or possible suspension of operations, depending on the violation and risk involved. The FDA describes DSCSA as a system designed to identify, trace, and remove potentially harmful drugs from the U.S. supply chain.
Non-compliance also creates added concern when a pharmacy knowingly transfers or receives a product that does not meet DSCSA requirements. In DSCSA knowingly violations, intent matters because the pharmacy may face greater legal exposure if it understands the product or transaction is non-compliant and still moves forward.
The risk does not stop with regulators. Non-compliance can disrupt purchasing, delay product movement, weaken trading partner trust, and raise patient safety concerns if suspect or illegitimate products enter the pharmacy workflow.
Compliance ownership also matters. Your wholesaler, manufacturer, or technology provider may support DSCSA requirements, but the pharmacy still holds responsibility for its own compliance process, records, trading partner checks, and response procedures.
DSCSA 360™ helps pharmacies reduce these risks by giving teams a clear system for documentation, verification support, trading partner management, and ongoing compliance tracking before problems turn into enforcement issues.
Benefits of the DSCSA Compliance Solution for Pharmacies
Implementing DSCSA 360™ helps pharmacies improve both compliance and operational efficiency.
Key Benefits Include:
Reduced compliance risk
Better audit preparedness
Simplified EPCIS management
Centralized transaction records
Improved staff training
Faster access to compliance documentation
Reduced manual processes
Ongoing expert support
Better visibility across trading partners
Consolidated recall and verification workflows
Most importantly, pharmacies gain confidence knowing they have systems and processes designed specifically for DSCSA compliance.
Trusted Partnership for DSCSA Compliance
Advasur has been involved with Track & Trace requirements since the creation of DSCSA legislation. Like PRS Pharmacy Services, Advasur was built by pharmacists who understand the operational realities pharmacies face every day.
Together, PRS and Advasur created DSCSA 360™ to provide pharmacies with a turnkey compliance solution that reduces complexity and supports long-term compliance readiness.
Why Pharmacies Trust PRS and Advasur:
- Pharmacist-developed compliance solution
- Pharmacy-focused software platform
- DSCSA operational expertise
- Audit-tested compliance processes
- Ongoing customer support
- Affordable compliance programs
- Endorsed by pharmacy industry organizations
This product is endorsed by FPN and NCPA, representing more than 15,000 independent pharmacies nationwide.
Take the Next Step toward
Full DSCSA Compliance
Preparing for DSCSA compliance becomes easier when you have the right software, workflows, and support team behind you.
Schedule a demo with PRS Pharmacy Services to see how DSCSA 360™ can simplify compliance for your pharmacy.
Success Stories from PRS Clients
Pharmacy owners, operators and association leaders on what it’s like to work with PRS Pharmacy Services.
Who This DSCSA Compliance Solution Is For
DSCSA 360™ is designed for pharmacies and healthcare organizations that need a practical, flexible compliance solution.
This Solution Is Ideal For:
Independent Pharmacies
Community Pharmacies
Multi-Location Pharmacy Groups
Specialty Pharmacies
Long-Term Care Pharmacies
Compounding Pharmacies
Health System Pharmacies
Pharmacy Ownership Groups
Whether your pharmacy is preparing for EDDS requirements or improving existing DSCSA processes, DSCSA 360™ helps integrate compliance management.
The 5 Key Areas of DSCSA Compliance for Pharmacies
DSCSA compliance involves multiple operational and technical requirements that pharmacies must maintain consistently. Understanding these core areas helps pharmacies prepare for audits, improve workflows, and reduce compliance risk.
Authorized Trading Partners
Pharmacies must verify that manufacturers, wholesalers, and other trading partners are properly licensed and registered. Missing or expired credentials can create compliance risks during audits and inspections.
DSCSA 360™ helps pharmacies organize and track ATP documentation.
Product Identifiers
Covered prescription drugs must include product identifiers such as serial numbers, NDCs, lot numbers, and expiration dates. Pharmacies must ensure incoming products meet DSCSA labeling requirements.
Product Tracing
Pharmacies must receive and maintain transaction information and transaction statements before or at product delivery. Missing or incorrect transaction data should be investigated and corrected promptly.
DSCSA 360™ helps pharmacies centralize and retrieve transaction records quickly during audits and inspections.
Verification Process
Pharmacies must quarantine and investigate suspect or illegitimate products. DSCSA also requires pharmacies to maintain investigation records and report illegitimate products to the FDA within required timelines.
DSCSA 360™ helps pharmacies standardize verification workflows and documentation procedures.
Enhanced Drug Distribution Security (EDDS)
EDDS requires secure electronic transaction exchange using interoperable systems like EPCIS. Pharmacies must prepare for increased traceability, electronic documentation, and faster regulator response requirements.
DSCSA 360™ helps pharmacies prepare for these enhanced electronic compliance requirements through centralized EPCIS management tools.
Don’t Wait Until It’s Too Late.
DSCSA enforcement deadlines are approaching quickly, and implementation delays can create operational and compliance risks for pharmacies.
Start preparing now with guidance from pharmacy compliance experts.
Fill out the form today or call 800-338-3688 to learn more about DSCSA 360™.
See the DSCSA Compliance Solution in Action
A live demo helps pharmacies understand how DSCSA 360™ simplifies EPCIS management, transaction monitoring, audit preparation, and compliance workflows. Our team can walk you through the platform and answer questions specific to your pharmacy operations.
Why Choose PRS Pharmacy Services
DSCSA Compliance Solution?
Pharmacies choose PRS because we understand both compliance requirements and real pharmacy operations.
What Sets DSCSA 360™ Apart:
- Built by pharmacists for pharmacies
- Centralized DSCSA software platform
- Practical workflow-focused design
- Audit-tested compliance processes
- Ongoing support from compliance professionals
- Affordable implementation options
- Complete SOP and training resources
- End-to-end compliance guidance
Unlike generic compliance platforms, DSCSA 360™ was designed specifically around pharmacy operations and FDA expectations.
FAQs About DSCSA Compliance Solution
The Drug Supply Chain Security Act (DSCSA) is a federal law passed in 2013 to improve prescription drug traceability and protect the U.S. drug supply chain from counterfeit, stolen, or illegitimate medications.
The law requires pharmacies and other trading partners to maintain secure product tracing, verification, and transaction documentation processes, including upcoming Electronic Drug Distribution Security (EDDS) requirements.
Pharmacies must currently comply with four core DSCSA requirements:
- Authorized Trading Partners
- Product Identifiers
- Product Tracing
- Verification Procedures
Pharmacies are also expected to continue preparing for enhanced electronic transaction requirements under EDDS.
DSCSA was created to improve drug supply chain security by helping pharmacies and regulators identify, trace, and respond to suspect or illegitimate prescription medications more effectively.
Pharmacies must:
- Purchase products from authorized trading partners
- Maintain transaction records and product tracing data
- Verify suspect or illegitimate products
- Retain required records for six years
- Prepare for secure electronic EPCIS data exchange under EDDS
Certain products are exempt, including:
- Blood and blood components
- Medical gases
- Certain intravenous products
- Homeopathic drugs
- Compounded drugs under sections 503A and 503B
Pharmacies should have compliant SOPs, employee training, transaction recordkeeping processes, verification procedures, and systems for managing EPCIS transaction data and authorized trading partner documentation.
DSCSA 360™ helps pharmacies centralize and manage these requirements through one platform.
No. Your wholesaler may provide T3 or EPCIS transaction data, but your pharmacy still owns its DSCSA compliance.
Compliance ownership remains with the pharmacy. That means your team must still verify products, store transaction records, maintain SOPs, train staff, document suspect product procedures, track Authorized Trading Partner records, and prepare for audits or regulator requests.
A partnered DSCSA approach works best. Your wholesaler can supply the required transaction data, while a DSCSA-focused solution like DSCSA 360™ helps your pharmacy organize records, manage workflows, monitor compliance gaps, and document required procedures.
Relying on your wholesaler alone creates a compliance gap and enforcement risk.
EPCIS (Electronic Product Code Information Services) is the electronic format used to securely exchange DSCSA transaction data between trading partners.
It supports electronic product tracing and interoperability requirements under EDDS.
A Global Location Number (GLN) is a GS1-issued identifier used to support secure EPCIS transaction exchanges between trading partners.
Many pharmacies will need a GLN to participate in EDDS-compliant electronic data exchange.
Most DSCSA transaction records, verification documents, and investigation files must be retained for at least six years.
DSCSA 360™ helps pharmacies organize transaction records, SOPs, training documentation, and verification workflows in one centralized system for faster audit preparation and response.
Manual compliance is possible, but difficult to maintain long-term. Managing EPCIS files, transaction records, and verification procedures manually increases the risk of missing documentation and compliance gaps.
Most pharmacies benefit from centralized DSCSA compliance software.
Implementation timelines vary based on pharmacy size, workflows, and trading partner setup. Because onboarding and EPCIS integrations can take weeks or months, pharmacies should begin preparing well before enforcement deadlines.
No. While DSCSA applies to most prescription medications, certain categories, such as compounded products, blood products, and medical gases, are exempt under federal law.
Your Pharmacy Deserves a Simpler Path to DSCSA Compliance
Contact PRS Pharmacy Services today and let us show you how DSCSA 360™ can simplify compliance for your pharmacy.