Understanding Distinctions in FMD (EU) and DSCSA (US) Regulations

Navigating the Differences and Current State of the FMD and DSCSA  Key Takeaways:  Comprehensive explanations of FMD and the DSCSA How do FMD and DSCSA…

Navigating the Differences and Current State of the FMD and DSCSA 

Key Takeaways: 

  • Comprehensive explanations of FMD and the DSCSA
  • How do FMD and DSCSA compare?
  • Find out what FMD and DSCSA have in common and how they differ.   

Regulatory compliance laws for the FMD (Falsified Medicines Directive) and the DSCSA (Drug Supply Chain Security Act) involve integrating new technology to track drug quality from creation to the last mile of their journey

The FMD applies to businesses operating within the European Union (EU), and the DSCSA applies to those operating in the United States (US). Like many regulations, both are required for pharmaceutical manufacturing and supply businesses. 

To properly comprehend and implement regulations, one must understand their differences and intricacies. Implementing, monitoring, and ensuring compliance is a resource-intensive task that requires a solid strategic plan. Pharmaceutical regulations help ensure drugs shipped to patients are of the highest quality and legitimately created under the correct conditions for maximum potency and safety. 

Additionally, these regulations help to control the creation of drug products and reduce the risk of theft, manipulation, or damage that adversely affects patient health and safety. 

This guide compares FMD and DSCSA compliance regulations with a focus on meeting the 2024 implementation requirements.   

Falsified Medicines Directive (FMD) – EU

The FMD impacts all 27 European Union (EU) member states and the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway. So, in total, it affects more than 30 countries within the European Union and its associated nations. The FMD aims to protect public health by preventing the entry of falsified medicines into the legal supply chain. 

The FMD also impacts pharmaceutical manufacturers or suppliers doing business in any of the EU countries. The FMD is quite simple in theory – it requires that safety features and drug information be included in prescription drug packages. 

Safety features include anti-tamper packaging and a unique product identifier composed of serial number, product code, and batch number. Once individual meds are serialized with unique ID numbers, all the data is sent to a centralized EU data repository. When any medication unit is dispensed to a patient, the unit is scanned and verified. 

FMD has been an active regulation since 2019 and applies to pharmaceutical manufacturers, wholesalers, re-packagers, parallel traders, and pharmacies. FMD is critical for keeping illegal or unauthorized drugs from being used by patients. New drug companies must comply with FMD before doing business in the EU. 

Drug Supply Chain Security Act (DSCSA)

The DSCSA is intended to protect consumers from counterfeit, stolen, or contaminated drugs that don’t meet quality standards or were damaged during shipping. Removing dangerous drugs from the supply protects patient safety.

DSCSA is nearly at completion. As of 2024, the only remaining enactment is the 1-year stabilization period currently in progress until November 27, 2024. Currently, pharmaceutical manufacturers and suppliers are working any kinks out of their electronic drug tracking and tracking systems for drug packages or shipments. The requirement requires companies to provide only electronic documentation of drugs and their supply chain journey. 

The DSCSA one-year extension by the FDA (Food and Drug Administration) means enforcement of the regulators does not begin until late November 2024, so the drug supply chain is not interrupted. Businesses needing to meet the regulation should be tested to ensure everything functions as expected. 

In other words, the technology should be in place and being tested. If you’re not currently testing your electronic record delivery system, then you are behind on the final DSCSA regulations for providing interoperable electronic tracing for each product at the package level.  

DSCSA regulations already active since 2023 include:

  • Wholesale distributors must verify returned drug products. 
  • Wholesale distributors must investigate suspected illegal medicines. 
  • All drug supply chain businesses must report suspect or illegitimate products to the FDA. 
  • Participate in the reporting process by supplying the FDA with the product, how it was discovered, and all supporting evidence and documentation. 
  • Assist the FDA in coordinating efforts to remove the medication from the supply chain. 
  • The FDA guarantees companies reporting illegitimate drugs are not liable when they cooperate with the FDA investigation. 

Requiring the reporting of illegal products promotes transparency and collaboration within the industry to eliminate illegal products for patient safety and business protection. Keeping illegal drugs out of the supply chain is critical to the security and integrity of all legitimate drug supply chain members. 

Comparative Analysis: FMD and DSCSA

The US is the largest pharmaceutical market in the world. That said, the final testing stage before compliance is required for electronic product tracking ends in November 2024. For pharmaceutical companies, this last step of the DSCSA is essential. On the other hand, the EU’s FMD has already been in place for four years. So, companies within the European Union are likely already compliant with FMD regulations. Still, there are differences between the FMD and DSCSA that are essential to understand, especially for how the products need to be read/tracked, resulting in the need for 2 bar codes and additional coding so that current systems can read and share data in the templates needed.  

When new companies are formed or new drugs enter the market, they must fully comply with the DSCSA and/or FMD, depending on where you manufacture, sell, or deliver. 

One difference between the FMD and DSCSA is how products are handled after being received by the pharmacy. For the DSCSA, product and data must be validated by serial number when received. In other words, the product’s received serial number must match the transaction record. Products must have a serial number, lot number, expiration date, and an NDC (National Drug Code) number. The DSCSA does not require serial numbers to be decommissioned. 

For the FMD, pharmacies are equipped to scan and validate serial numbers when drugs are dispensed. Each drug serial ID is then decommissioned from the centralized database. The FMD requires collecting and tracking a product code, drug registration number, lot number, expiration date, and unique serial number for each product. The FMD requires lost, stolen, or spoiled drugs to be decommissioned and removed from the central database. 

Both regulations have different requirements for serial ID implementation- resulting in the need for multiple serial IDs to be the complainant in both areas. The problem comes in when drugs are manufactured, sold, or shipped to both the US and EU. When this occurs, manufacturers must then use different serial numbers. Additionally, both regulations verify drugs at different times. For the DSCSA, drugs are only verified when they are returned as suspects. The FMD requires drugs to be verified when dispensed. 

When planning to comply with both regulations, be sure to follow each declaration. Within your compliance strategy, define the serial numbers you need for both and the required verification procedures, tracking, and tracing. If you do business in the US and EU, it’s highly recommended that you compare the two regulations side by side. Decide how best to implement both standards at the same time. 

For example, since both require electronic product tracking and secure data exchange, you can use one system. Determine how to manage the serial numbers so they’re easy to identify in the US or EU. 

Need Help with DSCSA or FMD Compliance?

Regulations help protect businesses and consumers. Exchanging and sharing data, including tracking products throughout the chain of custody. 

A quality cold chain is essential for ensuring drugs are stored and shipped properly, and quality is retained. Contact us to determine what products work for your supply chain compliance needs. SpotSee products are developed to provide solutions to improve your pharmaceutical cold chain and comply with current regulations