DSCSA Compliance: A Comprehensive Guide for Wholesalers
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by SurgiMac LLC
9 min reading time
The Drug Supply Chain Security Act (DSCSA) was put into effect in 2013 to improve the tracking of prescription medications, in the United States with the goal of stopping unauthorized drugs from getting into the distribution system to keep patients safe and safeguard the honesty of the pharmaceutical sector. Wholesalers need to grasp the intricacies of DSCSA adherence to steer clear of fines and uphold a standing.
Key DSCSA Requirements for Wholesalers
For wholesalers, it is essential to grasp the key aspects of the Drug Supply Chain Security Act (DSCSA).
Product Identifier Verification
UPI Verification: Each prescription drug must have a unique product identifier (UPI). Wholesalers must verify the UPI of each product before further distribution.
Serialization: The UPI is typically encoded on a serialized package, allowing for individual tracking.
Verification Systems: Wholesalers must have systems in place to verify UPIs against authorized trading partner databases.
Transaction History
Record Keeping: Wholesalers must maintain a detailed record of all transactions involving prescription drugs, including:
Date of transaction
Quantity of drugs
UPI of each product
Names and addresses of trading partners
Electronic Pedigrees: Electronic pedigrees are a digital record of a drug's journey through the supply chain. Wholesalers must ensure that pedigrees are accurate and up-to-date.
Suspect Product Reporting
Identification: Wholesalers must be able to identify suspect products, such as those with discrepancies in packaging, labeling, or UPIs.
Notification: If a wholesaler suspects a product is counterfeit, diverted, or otherwise illegitimate, they must notify the FDA and all appropriate trading partners within 24 hours.
Quarantine: Suspect products must be quarantined to prevent further distribution.
Returned Product Verification
Saleable Returns: Wholesalers must verify the UPI of saleable returned products to ensure they are not counterfeit or diverted.
Verification Systems: Similar to initial distribution, wholesalers must use verification systems to check UPIs of returned products.
Annual Reporting
Licensure Information: Wholesalers must report their licensure status, including state licenses and any disciplinary actions.
Ownership Information: Information about the wholesaler's ownership structure and contact details must be provided.
Other Data: Additional data may be required, such as the number of employees and the types of drugs distributed.
It’s important for you to be aware of key dates in the legislation’s timeline so that you can affectively navigate DSCSA compliance.
DSCSA Implementation Timeline Extended
It's important to be aware of the key dates in the DSCSA implementation timeline, especially with the recent extensions:
DSCSA Enactment: November 27, 2013
Initial Compliance Deadline (Extended): November 27, 2024
Current Compliance Deadline: While the initial deadline for full implementation was November 2023, the FDA has recently issued exemptions extending the deadline for certain trading partners.
Manufacturers and Repackagers: May 27, 2025
Wholesale Distributors: August 27, 2025
Dispensers with 26 or more full-time employees: November 27, 2025
Verification Systems Under Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Section 582 of the FD&C Act requires trading partners to have verification systems in place to identify, quarantine, investigate, and dispose of suspect and illegitimate products. These systems should be designed to ensure consistent, effective, and timely identification of suspect products and to facilitate communication with trading partners and the FDA.
DSCSA Compliance Best Practices
Technology Investment: Implement a robust technology solution to manage product identifiers, track transactions, and facilitate compliance.
Employee Training: Ensure that employees are well-trained in DSCSA regulations and understand their responsibilities.
Regular Audits: Conduct regular audits to assess compliance and identify potential vulnerabilities.
Stay Updated: Keep up-to-date with any changes or updates to DSCSA regulations.
Partnerships: Collaborate with trading partners to ensure seamless data exchange and compliance.
Challenges and Considerations
Interoperability: Ensuring interoperability between different systems and databases can be challenging.
Small Wholesalers: Smaller wholesalers may face unique challenges in implementing DSCSA compliance measures.
Cost: Investing in technology and training can be costly, particularly for smaller businesses.
Key Points for Verification Systems
Determine Suspect Products: Trading partners must have systems in place to identify suspect products based on discrepancies in packaging, labeling, or UPIs.
Quarantine and Investigate: Upon identifying a suspect product, wholesalers must quarantine it and conduct an investigation to determine if it is illegitimate.
Disposition: If a product is determined to be illegitimate, it must be disposed of and appropriate notifications made to the FDA and other trading partners.
Electronic Systems: Verification systems may include electronic means to designate products as quarantined and to facilitate communication with trading partners and the FDA.
Ensuring Compliance and Protecting Public Health
Compliance with the DSCSA is really crucial for wholesalers to protect public health and avoid penalties. By understanding the key requirements, wholesalers can ensure their operations align with the DSCSA's objectives.
We hope this blog has provided an explanation of the implications of the DSCSA for your operations as a wholesaler. If you have any questions, please do not hesitate to contact SurgiMac. We are committed to supporting you in meeting requirements and securing the integrity of your distribution network.
FAQs About DSCSA
What is the Purpose of DSCSA?
The overall objectives of DSCSA are primarily aimed to protect patients from counterfeit drugs and enhance the safety of the supply chain of pharmaceutical products. This ensures prescription medications can be accurately tracked and traced from manufacturers to end consumers in a manner that safeguards public health.
What is DSCSA for Dummies?
Fundamentally, the DSCSA is designed to ensure the safety and legitimacy of prescription drugs as they move through the supply chain. This will require tracking systems which can verify drugs, thereby stopping the spread of counterfeit medications into the patients' hands.
What is the Present DSCSA Requirement?
The building of a good tracking and tracing system for all prescription drugs requires implementation after November 27, 2024. While full implementation for the said requirement was initially set to be implemented on November 27, 2023, the FDA has lately issued exemptions, considering the hardships of the industry, where some trading partners are qualified to be given longer deadlines for the full requirements themselves-to May 27, 2025 for manufacturers and repackagers; and for wholesale distributors, it is August 27, 2025
What Are Not Under DSCSA?
Some of the items exempted under DSCSA include Bacteria Items, Blood/Isolated Cells, Eye Products, Hormone Concentrates-LEGALLY EXEMPT HUMAN AND ANIMAL GROWTH PRODUCTS AND BIOLOGICAL, Pharmaceutical products OTC and Prescription Medicinal Drugs for Human Use, Sterile and nonsterile medical devices, Radiological drugs and other medicinal or medical products. Some of the drugs that are not covered by DSCSA are drugs sold for direct patient use, compounded prescription, and investigational drugs, which have different regulatory requirements.
What is the DSCSA Requirement?
DSCSA is particular requirements to which bodies operating in the pharmaceutical supply chain must adhere to include tracking, verification, and record keeping on the drug.
Who Implements DSCSA?
Since 2013, the U.S. Food and Drug Administration has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful.
Does DSCSA apply to clinics?
Yes, DSCSA compliance applies to clinics, particularly those involved in dispensing prescription medications to patients.
If you are a medical professional, you can read our other blog on DSCSA where we talk about what DSCSA means specifically for your field:
Meticulous record keeping is crucial for several reasons:
Traceability: In the event of a recall or investigation, records allow for quick and efficient tracing of a product's journey through the supply chain.
Compliance: Proper record keeping is essential for demonstrating compliance with DSCSA requirements and avoiding penalties.
Patient Safety: By helping to identify and remove counterfeit or adulterated drugs from the supply chain, accurate record keeping contributes to patient safety.
Tips for Effective Record Keeping:
Electronic Systems: Implement electronic systems for efficient data capture, storage, and retrieval.
Standardized Procedures: Develop and follow standardized procedures for all record-keeping tasks.
Regular Audits: Conduct regular internal audits to ensure compliance and identify areas for improvement.
Training: Provide comprehensive training to all personnel involved in record keeping.
Disclaimer: The information provided in this blog is intended for general guidance only and should not be considered as legal or regulatory advice. Wholesalers are encouraged to conduct their own research and consult with legal or compliance professionals to verify the accuracy and applicability of the DSCSA requirements to their specific operations.
