New 2023 Pharmaceutical Guidelines: Ensuring Compliance with the Drug Supply Chain Security Act (DSCSA)

New 2023 Pharmaceutical Guidelines: Ensuring Compliance with the Drug Supply Chain Security Act (DSCSA) 

In recent years, the pharmaceutical industry has faced numerous challenges related to the supply chain security of pharmaceutical products. The Drug Supply Chain Security Act (DSCSA) was enacted by the US Congress in 2013 to enhance the security of the drug supply chain and protect patients from the risks associated with counterfeit and contaminated drugs. With the new year, 2023 brought new guidelines for pharmaceutical manufacturers, distributors, and dispensers to ensure compliance with the DSCSA.

In this article, we’ll discuss these new guidelines, give you a detailed look into how they may affect your pharmaceutical company, and offer some tips on how to easily remain compliant. Read on to learn more. 

What is the Drug Supply Chain Security Act?

The Drug Supply Chain Security Act (DSCSA) is a federal law that sets forth a series of requirements for the pharmaceutical industry to maintain the security of the drug supply chain. These guidelines require the pharmaceutical industry to implement a system for tracking and tracing prescription drugs as they move through the supply chain. The goal of the DSCSA is to protect patients from counterfeit and contaminated drugs by ensuring that pharmaceutical products are properly identified, tracked, and authenticated at every step of the supply chain.

New 2023 Guidelines

In March of 2023, the FDA issued new guidelines for the pharmaceutical industry to ensure compliance with the DSCSA. These guidelines include several new requirements and best practices that pharmaceutical manufacturers, distributors, and dispensers must follow to ensure the security of the drug supply chain. Here’s what they include:

1. Verification of prescription drugs
   One of the most significant changes to the DSCSA is the requirement for all prescription drugs to be verified prior to dispensing. The verification process must confirm that the drug is not counterfeit, adulterated, or misbranded. This requirement applies to all prescription drugs that are distributed in the United States, including those imported from other countries.
   
   
2. Serialization
   The DSCSA also requires pharmaceutical manufacturers to implement a serialization system that assigns a unique identifier to each individual drug package. This unique identifier must be tracked and recorded throughout the entire supply chain, from the manufacturer to the dispenser.
   
   
3. Enhanced communication
   The FDA is encouraging enhanced communication between pharmaceutical manufacturers, distributors, and dispensers to improve the tracking and tracing of prescription drugs. This includes sharing information about suspect or illegitimate products, as well as information about product recalls.
   
   
4. Improved data management
   The DSCSA also requires pharmaceutical companies to improve their data management practices to ensure that all information related to drug products is accurate and up-to-date. This includes maintaining complete and accurate records of all drug transactions, including information about the source and destination of each drug package.
   
   
5. Training programs
   To ensure compliance with the DSCSA, pharmaceutical companies are required to provide training programs for all employees involved in the handling, storage, and distribution of prescription drugs. These programs must cover topics such as product identification, verification, and tracking, as well as procedures for handling suspect or illegitimate products.

How Will These Guidelines Affect Your Pharmaceutical Company? 

The new guidelines for compliance will have a significant impact on pharmaceutical companies. Here are some of the ways you can expect your company to be affected:

1. Increased costs: Implementing the necessary systems and procedures to comply with the DSCSA guidelines will require a significant investment of time and resources. This could result in increased costs for pharmaceutical companies, especially for smaller companies with limited resources.
   
   
2. Improved supply chain security: The DSCSA guidelines are designed to enhance the security of the drug supply chain and protect patients from counterfeit and contaminated drugs. Compliance with these guidelines will help pharmaceutical companies to ensure the safety and quality of their products, which could enhance their reputation and increase customer trust.
   
   
3. Operational changes: Pharmaceutical companies will need to make operational changes to comply with the DSCSA guidelines, such as implementing serialization systems and improving data management practices. These changes may require new technology investments and additional staff training.
   
   
4. Regulatory compliance: Failure to comply with the DSCSA guidelines can result in significant penalties and fines, as well as damage to a company's reputation. Pharmaceutical companies must ensure that they comply with the guidelines to avoid these negative consequences.

Overall, the new guidelines for compliance with the DSCSA will require pharmaceutical companies to make significant changes to their operations and invest in new technology and training. However, compliance with these guidelines can also enhance the security and quality of their products and protect the health and well-being of patients.

How Can a Document Management System Help Meet These Guidelines?

A document management system (DMS) can be a valuable tool for pharmaceutical companies to help meet the guidelines set forth in the DSCSA. Here are some ways that a DMS can help you remain compliant:

1. Traceability: A DMS can help with the serialization and tracking of prescription drugs throughout the supply chain. It can assign unique identifiers to each individual drug package and track and record this information throughout the supply chain.
   
   
2. Document control: These systems can also help with maintaining complete and accurate records of all drug transactions, including information about the source and destination of each drug package. It can also control access to these records, ensuring that only authorized personnel have access to sensitive information.
   
   
3. Improved data management: A DMS can improve your data management practices, which is a requirement of the DSCSA guidelines. It can ensure that all information related to drug products is accurate and up-to-date and provide tools to help identify and correct data errors.
   
   
4. Employee training: A document management system provides a centralized location for storing and delivering training materials to employees involved in the handling, storage, and distribution of prescription drugs. It can also track employee training records to ensure compliance.
   
   
5. Compliance reporting: These systems offer the ability to generate reports on compliance with the DSCSA guidelines, including information on product identification, verification, and tracking, as well as procedures for handling suspect or illegitimate products. These reports can help pharmaceutical companies identify areas for improvement and demonstrate compliance to regulatory agencies.

The new 2023 guidelines for compliance with the DSCSA are aimed at enhancing the security of the drug supply chain and protecting patients from the risks associated with counterfeit and contaminated drugs. Pharmaceutical companies must ensure that they implement the necessary systems and procedures to comply with the new guidelines and maintain the integrity of the drug supply chain. 

Failure to comply with these guidelines can result in significant penalties and fines, as well as damage to a company's reputation. By embracing these new guidelines and implementing a robust document management system, companies can better meet these requirements and help protect patients from harm.

With the help of ENSUR Document Control Management, you can easily prepare your company to meet these new FDA guidelines, boost efficiency, and increase collaboration. To learn more, contact us today.

Check out our other resources that offer tips on simplifying regulatory compliance: 

• How To Address Electronic Signature Compliance
• How to Prepare for and Resolve a Pharmaceutical Compliance Crisis
• 6 Tips to Help Guarantee Pharmaceutical Regulatory Compliance
• Top 3 Compliance Issues That Can Be Solved by Automation
• Best Practices from an Expert on the Quality Audit Process

Tom Tassias is DocXellent's Chief Technology Officer. After joining our team in 2006, he became responsible for providing technical leadership and creating innovative, best-in-class products and document solutions for our customers. Before working at DocXellent, Tom held roles in Information Technology, software development, technical leadership, and project management. Learn more about Tom and the work he does for DocXellent here.