Executive Summary

NAVIGATING THE DRUG SUPPLY CHAIN SECURITY ACT: A GUIDE FOR PHARMACEUTICAL MANUFACTURERS

The Drug Supply Chain Security Act (DSCSA) represents a significant shift in pharmaceutical supply chain management, aimed at enhancing security, combating counterfeit medications, and improving product traceability. This white paper provides a comprehensive overview of the DSCSA, its requirements, and strategies for compliance, specifically tailored for SMB & virtual manufacturers of pharmaceuticals.

What is the DSCSA?

LEGISLATIVE BACKGROUND AND GOALS

The DSCSA, enacted in 2013 as part of the Drug Quality and Security Act (DQSA), is a federal law designed to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This legislation aims to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

KEY PROVISIONS AND THEIR IMPLICATIONS

The DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace prescription drugs distributed in the United States. Key provisions include:

  • Product identification
  • Product tracing
  • Product verification
  • Detection and response to suspect and illegitimate products
  • Notification of illegitimate products to trading partners
    and FDA
  • Wholesaler licensing
  • Third-party logistics provider licensing

These provisions have far-reaching implications for all participants in the pharmaceutical supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers.

Objectives of the DSCSA

ENHANCING SECURITY WITHIN THE DRUG SUPPLY CHAIN

The DSCSA aims to create a closed system where drug products can be tracked from the point of manufacture to the point of dispensing. This enhanced security helps to prevent the introduction and distribution of counterfeit, diverted, or otherwise harmful drugs.

COMBATING COUNTERFEIT MEDICATIONS

By implementing stringent tracing and verification requirements, the DSCSA makes it significantly more difficult for counterfeit medications to enter the legitimate supply chain. This protects patients from potentially harmful or ineffective treatments.

IMPROVING PRODUCT TRACEABILITY AND ACCOUNTABILITY

The act mandates the creation of an electronic, interoperable system to track and trace prescription drugs. This improves the efficiency of drug recalls and returns, enhances the detection of illegitimate products, and facilitates the verification of drug product legitimacy.

Challenges for Small Virtual Pharmaceutical Manufacturers

Compliance with the DSCSA presents significant challenges for virtual pharmaceutical manufacturers, but it also offers opportunities for enhancing operational efficiency and building trust with partners and consumers. By understanding the requirements, leveraging technology, and implementing robust strategies, virtual manufacturers can not only meet regulatory demands but also position themselves for long-term success in an increasingly secure and transparent pharmaceutical supply chain.

IDENTIFYING RESOURCE LIMITATIONS AND EXPERTISE GAPS

Small virtual manufacturers often face:

  • Limited in-house technical expertise for implementing serialization systems
  • Insufficient staff dedicated to compliance and quality assurance
  • Lack of established processes for managing complex regulatory requirements
MANAGING IMPLEMENTATION COSTS WHILE ENSURING COMPLIANCE

Challenges include:

  • High initial investment in serialization technology and software
  • Ongoing costs for system maintenance and upgrades
  • Potential production delays during implementation
ADDRESSING COMPLEXITIES IN NAVIGATING REGULATIONS

Small manufacturers may struggle with:

  •  Interpreting and applying complex regulatory requirements
  •  Keeping up with evolving standards and deadlines
  • Coordinating compliance efforts across multiple contract manufacturing organizations (CMOs)
STRATEGIES TO MAINTAIN COMPETITIVENESS AMIDST COMPLIANCE DEMANDS

To remain competitive, consider:

  • Leveraging compliance as a differentiator in the market
  • Exploring partnerships or shared services to distribute costs
  • Implementing scalable solutions that can grow with your business

Key DSCSA Requirements

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SERIALIZATION REQUIREMENTS

1. Importance of Unique Device Identification (UDI)
Unique Device Identification is crucial for tracking individual units of prescription drugs
through the supply chain. It enables:

  • Rapid identification of suspect an/or counterfeit products
  • Enhanced patient safety through improved product recalls
  • Better inventory control and supply chain efficiency

2. Barcoding and Serialization Standards Explained
The DSCSA requires manufacturers to serialize prescription drug products at the smallest saleable unit level. This involves:

  • Assigning a unique, product identifier
  • Encoding the identifier in both human-readable format and machine-readable 2D data matrix barcode
  • Including the product's National Drug Code (NDC), serial number, lot number, and expiration date
PRODUCT IDENTIFICATION AND VERIFICATION

1. Essential Requirements for Product Identification
Manufacturers must ensure that each package and homogenous case of product contains:

  • A unique product identifier
  • A standardized numerical identifier
  • Lot number
  • Expiration date


2. How to Implement Verification Processes Effectively
Effective verification processes should include:

  •  Systems to authenticate the product identifier of suspect products
  • Quarantine and investigation procedures for suspect products
  • Clear protocols for notifying the FDA and trading partners about illegitimate products
  • Mechanisms to respond promptly to verification requests from authorized trading partners
RECORD KEEPING AND REPORTING

1. Best Practices for Documenting Transactions
Maintain comprehensive records of:

  • Transaction information (TI): Product name, strength, dosage form, NDC, container size, number of containers, lot number, transaction date, shipment date, and name and address of trading partners
  • Transaction statement (TS): A statement that the entity transferring ownership is authorized and did not knowingly ship illegitimate product

2. Understanding Reporting Requirements to the FDA
Be prepared to:

  • Report suspect or illegitimate products within 24 hours of determination
  • Respond to FDA requests for information
  • Maintain records of investigations and notifications
  • Submit annual reports on pilot projects or other strategies to enhance the safety and security of the drug supply chain
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Strategies for Compliance

Step-by-Step Guidance Tailored for Small Manufacturers

BEST PRACTICES FOR IMPLEMENTING DSCSA REQUIREMENTS
1

Conduct a thorough gap analysis of current systems and processes

2

Develop a phased implementation plan with clear milestones

3

Start with pilot projects to test and refine your approach

4

Engage early and often with contract partners to ensure alignment

5

Invest in staff training and development to build in-house expertise

TOOLS AND PLATFORMS WE RECOMMEND

  • Cloud-based serialization solutions for flexibility and scalability
  • Integrated Enterprise Resource Planning (ERP) systems with DSCSA compliance modules
  • Blockchain technology for enhanced traceability and security
  • Mobile scanning applications for easy verification and authentication

COLLABORATING WITH THIRD-PARTY LOGISTICS PROVIDERS

  • Select 3PLs with demonstrated DSCSA compliance expertise
  • Establish clear communication channels and data sharing protocols
  • Conduct regular audits and performance reviews
  • Collaborate on continuous improvement initiatives

TRAINING AND EDUCATION. RESOURCES WE PROVIDE FOR STAFF DEVELOPMENT

  • Comprehensive DSCSA compliance manuals and standard operating procedures
  • Regular webinars and workshops on regulatory updates and best practices
  • Access to industry forums and networking events
  • Personalized consulting services for specific compliance challenges
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