Understanding DSCSA Compliance: A Guide for Pharma Supply Chain Managers
Is DSCSA compliance creating a dilemma for you, from which you cannot set free? Seems like additional costs of fines, disruptions, or some counterfeit drugs are easily getting through the gaps? This all-rounder guide not only explains DSCSA requirements and implementation schedules but also presents easy-to-follow tips to help companies in gaining and preserving compliance in the long run.
What is the DSCSA?
DSCSA is a US Drug Supply Chain Act that has been gradually coming to life since November 2013.
The Drug Supply Chain Security Act or DSCSA is a section of the Food and Drug Administration enacted in 2013. Rooting deep into the foundation, the DSCSA strives to push the pharmaceutical supply chain safety and shield patients from counterfeit, stolen, adulterated or other toxic drugs. To achieve this, the DSCSA focuses on several major goals:
- Enhanced Drug Tracking: The DSCSA requires all parties in the US supply chain to pass electronic, interoperable transactions for every individual prescription drug.
- Product Verification: The act provides a framework for verifying product originality at various points in the supply chain. It aims to be effective to identify activities containing a certain amount of doubt or products considered at risk for counterfeit.
- Counterfeit Prevention: DSCSA strives to minimize the chance of counterfeit drugs to invade the legitimate pharmaceutical supply chain and protect patient security as well as organizations reputation.
- Efficient Recalls: The DSCSA through its ability to conduct tracing of drug products on a precise level will contribute to more accurate recalls that will be narrower and having less threats to patients.
DSCSA works only in the United States’ pharmaceutical market, and drug counterfeiting is not a specific problem for the country but the world as a whole. Countries throughout the globe and, among others in the European Union, have implemented similar regulations to enhance patient’s well-being. Global companies which operate in different regulations can be challenged by custom serialization and tracking requirements. Supply Chain Wizard bridges regulatory gaps in the pharma industries, providing a transparent and solid framework for drug makers, to make sure they are cleared in the complex policies, bringing diversity in the market, but also filling gaps in safety processes and products.
Key Components of DSCSA Compliance
To achieve its goal of a secure and traceable pharmaceutical supply chain, the DSCSA outlines several key components that companies must implement:
Product Identification
Under the DSCSA, each package and homogenous case of prescription drugs must carry a unique product identifier comprised of the following data elements:
- GTIN (Global Trade Item Number): Company Prefix, National Drug Code and a calculated Check Digit
- Serial Number: Unique identifier to be placed on a single saleable unit
- Lot Number: Identifies the batch numbering on which the drug product was manufactured.
- Expiration Date: The date of the drug distribution is frozen at that time.
- Encoding – 2D Barcode: This product code can be easily read on the product packaging by computers like in other barcodes.
Product Tracing (The Three T’s)
DSCSA mandates the facility-to-facility transmission of information on the history of a drug at each stage of the supply chain at every venue. This information includes:
- Transaction Information (TI): The data that has product identifier (NDC, serial number, lot, expiration date), shipping and receiving date, and also business names/address of who ship and receive the product need to be involved in this system.
- Transaction History (TH): The most recently generated record will be presented electronically including copies of all previous transactions back to the manufacturer.
- Transaction Statement (TS): At this point the manufacturer provided the seller a statement that they are an authorized distributor who received TI, created TH, and could have not knowingly shipped counterfeits.
Product Verification
The DSCSA requires verifying the product identifier Instructions:
- Suspicious Products: In case a product appears fake, wrong channel or outright illegitimate channel.
- Returns: Before the re-sale of the product.
Systems for Information Exchange
Affirmative, electronic networks are a good choice to share the DSCSA data between supply chain participants. Key considerations for these systems include:
- Interoperability: A standard format in which approved partners exchange data.
- Security: Ideally these measures must prevent any sort of unintended exposure or alteration of the private data.
- Functionality: The technology is supposed to enable for all “track & trace” requests in line with the DSCSA.
DSCSA Impact on Pharma Supply Chain Managers
The DSCSA is not just a process that adds compliance tasks, but it requires a total overhaul of how pharmaceutical supply chains are managed. The supply chain managers should be well prepared to address several main topics. Changes associated with the operation will be reflected in the serialization, product tracing, warehouse management, shipping, receiving, and returns processes, pretty much all work streams within your organization. Security becomes an upgraded IT infrastructure requirement due to secure systems being needed for DSCSA data exchange, product verification, and aggregation, especially after 2023. Training the staff is also critical. Thorough knowledge of DSCSA requirements and ramp-up on the new process/systems needs to be extended to the whole supply chain. Finally, improving the collaboration with suppliers, distributors, dispensers, and technology partners will be key for the DSCSA compliance and resolution of possible issues.
DSCSA Deadlines: Where Do We Stand?
The DSCSA was passed with a ten-year implementation period. 2024 marks the end of this period, hence serialization is now considered business as usual in the US and disruption tolerance levels are low in the eyes of the authorities.
Here’s a summary of key past and upcoming deadlines:
- 2015 Lot Level Traceability: Manufacturers to track each of their product batches from creation to distribution
- 2017 Unit Level Serialization: Unique identifier on every saleable item as well as homogeneous case
- 2019 Verification of Saleable Returns: Wholesalers and/or Manufacturers to verify legitimacy of the product before placing it back into the supply chain
- 2023 Unit Level Traceability: Ability to verify legitimacy of product throughout the supply chain with 24 hrs of authorized inquiry.
A successful implementation relies on:
- Interoperability: The partners of the supply chain should be equipped to interchange and utilize the product tracing data without stumbling on the particular systems they use.
- Aggregation: The units must be traceable both individually and at higher packaging levels (cases, pallets) while an extra level of data management is needed.
- Technology Upgrades: The cost of equipment such as serialization software, verification systems, and aggregation support may become the main outlays for companies.
How Supply Chain Wizard Can Help?
Supply Chain Wizard is aware of multiple hurdles that pharmaceutical supply chain managers have to undergo under DSCSA. We provide consulting services and solutions in the field of DSCSA readiness assessment, technology selection and implementation, training of staff, and optimization of processes for pharmaceutical supply chain.
DSCSA requirements are a real challenge and always require updates.
Supply Chain Wizard assists companies in
- Monitoring deadlines by assessing their readiness and developing strategies ahead of time that will ensure that they are in compliance with the requirements
- Implementation of Serialization for any new product and supply chain setup
- Maintenance of Serialization systems and processes to ensure constant GxP compliance.
Conclusion
Compliance with DSCSA is an indispensable foundation of security and safety of the pharmaceutical supply chain. This is done by preventing patients from getting in contact with counterfeit or possibly harmful drugs. The DSCSA performance is not over by just complying with it. Reactive execution might be one approach but it does not offer perfect opportunities to streamline the operations, gain greater supply chain visibility and in the end to enhance overall security and efficiency of your pharma supply chain.
DSCSA is an intricate process that can be handled with professionalism and diligence. Supply Chain Wizard takes a holistic approach with full assessments, targeted plan for implementation, and ongoing support to ensure that you not only comply with the DSCSA but optimize your supply chain to the evolving environment. Contact us for a personalized consultation where we will help you maximize DSCSA compliance in your company.
For additional detail and help with Digital Maturity Assessment, please contact:
Mia Van Allen – Managing Partner – mia.vanallen@supplychainwizard.com
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