A Guide to DSCSA Compliance

Understanding the DSCSA is crucial for anyone involved in the pharmaceutical industry because this act helps prevent counterfeit drugs from entering the market, minimizes the risk of drug diversion, and improves traceability in case of product recalls.

Read on to find out everything you should know about DSCSA compliance, such as:

• What is DSCSA?
• DSCSA Requirements
• The Impact of DSCSA Compliance on Drug Manufacturers, Distributors, and Pharmacies
• Best Practices for Pharmacies to Ensure DSCSA Compliance
• Future Developments and Potential Changes to DSCSA

What is DSCSA?

The Drug Supply Chain Security Act (DSCSA) is a federal law enacted in the United States in 2013 to improve the safety and security of the pharmaceutical supply chain. Its primary aim is to enhance the ability to trace prescription drugs distributed throughout the supply chain, from manufacturers to pharmacies and ultimately to patients.

DSCSA Requirements

One of the central components of DSCSA compliance is serialization, which involves assigning a unique serial number to each unit of prescription drug packaging. Serialization is crucial for tracking and tracing products throughout the supply chain.

Manufacturers, wholesalers, repackagers, and dispensers all have specific requirements and deadlines to meet in terms of implementing serialization:

Manufacturers

Manufacturers must ensure that all prescription drug packaging is serialized by a certain deadline specified in the DSCSA regulations. They also provide product and transaction information to wholesalers and dispensers.

Wholesalers

Wholesalers must verify the legitimacy of the products they receive and pass on transaction information to downstream trading partners.

Repackagers

Repackagers must ensure that any repackaged products are properly identified and labeled with the necessary serialization information.

Dispensers

Dispensers, such as pharmacies, are responsible for verifying the authenticity of prescription drugs before dispensing them to patients. They must also keep records of transaction information.

Impact of DSCSA Compliance on Drug Manufacturers, Distributors, and Pharmacies

With the implementation of the DSCSA, drug manufacturers, distributors, and pharmacies must adhere to stringent guidelines to ensure the safety and security of prescription drugs. The DSCSA guidelines have led to increased transparency and accountability throughout the supply chain, as each stakeholder is now responsible for tracking and tracing the movement of pharmaceutical products.

• Drug Manufacturers: Manufacturers must now implement serialization and traceability measures to create a seamless flow of information from production to distribution, resulting in improved inventory management and product authentication and increased operational costs.
• Distributors: Distributors play a crucial role in verifying the authenticity of pharmaceutical products and preventing counterfeit drugs from entering the market. They must now conduct thorough due diligence before distributing any medication, leading to longer lead times and potential disruptions in the supply chain.
• Pharmacies: The Drug Supply Chain Security Act pharmacy responsibilities require verifying the legitimacy of prescription drugs before dispensing them to patients. The verification process has improved patient safety, reduced the risk of counterfeit medications, and added an extra layer of complexity to their operations.

Best Practices for Pharmacies to Ensure DSCSA Compliance

Ensuring compliance with the DSCSA is crucial for pharmacies to maintain patient safety and adhere to regulatory standards.

Here are some best practices for pharmacies to adhere to DSCSA compliance:

Invest in Training

Provide comprehensive training to pharmacy staff on DSCSA requirements, including proper documentation, record-keeping, and product verification procedures. Ensure that all staff members know their roles and responsibilities in maintaining compliance.

Implement Serialization and Traceability

Utilize technology to implement serialization and traceability systems for prescription drug inventory. Barcode scanning systems and electronic record-keeping can help pharmacies accurately track and document the movement of drugs throughout the supply chain.

Verify Product Identifiers

Before dispensing prescription drugs, verify the product identifiers (such as NDC, serial number, lot number, and expiration date) to ensure the authenticity and integrity of the products. Implement protocols for identifying and handling suspect or illegitimate products.

Maintain Transaction Records

Keep detailed transaction records for all prescription drug sales and transfers, including transaction history and statements. Ensure that these records are accurate, complete, and easily accessible for inspection by regulatory authorities.

Stay Informed About Updates

Stay abreast of updates and changes to DSCSA regulations and guidelines issued by the FDA. Review and update pharmacy policies and procedures regularly to reflect new requirements or best practices.

Establish Supplier Relationships

Develop strong relationships with reputable suppliers, wholesalers, and distributors who prioritize DSCSA compliance. Verify suppliers’ legitimacy and adherence to regulatory standards before entering into agreements or purchasing products.

Monitor Product Recalls and Alerts

Stay vigilant for product recalls, alerts, or notifications issued by manufacturers, distributors, or regulatory agencies. Implement procedures for promptly identifying and removing recalled or potentially harmful products from pharmacy inventory.

Regular Audits and Inspections

Regular internal audits and inspections should be conducted to assess DSCSA compliance practices and identify areas for improvement. External auditors or consultants should be engaged as needed to ensure thorough evaluations and compliance assessments.

By following these best practices, pharmacies can establish processes and protocols that ensure compliance with the DSCSA, safeguard patient safety, and maintain the integrity of the pharmaceutical supply chain.

Ensuring Patient Safety Through DSCSA Compliance

Taking steps to ensure patient safety is a top priority in the pharmaceutical industry. The Drug Supply Chain Security Act (DSCSA) plays a crucial role in regulating the supply chain of prescription drugs. Compliance with DSCSA requirements helps companies avoid penalties and ensures the safety and integrity of the products that reach patients.

• How DSCSA compliance helps ensure patient safety: By requiring the tracing and tracking of prescription drug products throughout the supply chain, DSCSA helps prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from reaching patients.
• Importance of regulated drug supply chains in protecting patients: With a regulated supply chain, patients can trust that the medications they receive are authentic, safe, and effective, which helps prevent potential harm or adverse reactions that could result from counterfeit or substandard drugs.

Future Developments and Potential Changes to DSCSA

The DSCSA is a continuously evolving regulation, with new requirements and guidelines regularly introduced. Companies must stay informed about these changes and adapt their compliance strategies accordingly. Possible future developments may include enhanced serialization requirements, increased traceability measures, and stricter penalties for non-compliance.

Staying up-to-date on regulatory changes is essential for maintaining DSCSA compliance. Failure to adhere to new requirements could result in significant penalties and disruptions to your operations. Monitoring updates and participating in industry discussions ensures that your company complies with the latest DSCSA regulations.

To stay informed about DSCSA changes,

• Regularly check for updates from the FDA and other regulatory bodies.
• Attend industry conferences and training sessions to stay informed.
• Engage with industry peers and organizations to discuss upcoming changes.

A Pharmaceutical Wholesale Supplier That Understands DSCSA Compliance

At RxRise, we pride ourselves on being more than just a pharmaceutical wholesale supplier—we’re your trusted partner in navigating the complexities of regulatory compliance, including the DSCSA. With a deep understanding of DSCSA requirements and a commitment to upholding the highest standards of safety and integrity in the pharmaceutical supply chain, we’re dedicated to ensuring our pharmacy partners maintain compliance at every step.

From over-the-counter (OTC) pharmaceuticals to prescription drugs, every wholesale pharmaceutical available on our marketplace platform is verified to ensure we help prevent counterfeit drugs from entering the market. Contact us today to schedule a demo of our platform.