US Drug Supply Chain Security Act
How the US Drug Supply Chain Security Act Impacts Manufacturers Catering to American Markets
Scope of the Law
The advantage of the DSCSA as opposed to the FMD is that it applies to all states equally, covering prescription drugs. The Falsified Medicines Directive applies to prescription drugs as well but the EU has published a whitelist of exempted pharmaceuticals. Given that a European Directive needs to be transposed into national law in each of the member states, application might vary as the FMD expressly leaves room for interpretation and certain national exceptions. Thus, the member states are free to add further drugs to the list covered by FMD requirements, meaning that medicines that do not need to be serialized in Portugal might have to be serialized in Poland.
Serialization and Coding Requirements
For the European market, randomized serial numbers can be generated on site by the manufacturer/ pharma company. A contract manufacturer might also get serial numbers from the pharma companies it produces for. Serial codes in the EU must not exceed 20 digits and be unique until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution, whichever is the longer period. In addition to the Serial Number, the FMD requires Lot Number, Expiry Date and Global Trade Item Number (GTIN) to be printed in machine- and human-readable format.
As many EU countries are already using some form of coding, migrating towards a GTIN-14 format should be pretty straight forward. The real challenge will be the coding of multi-market packs as the FMD allows for additional data elements to be printed on the packs, like reimbursement codes (NHRN or REIM) or the German PZN (Pharmazentralnummer). This means that, just to be able to cater to the seemingly harmonized EU market, you will need a rather flexible serialization solution.
The United States require unique product identification and printing of National Drug Code, 12-digit serial number, lot number, expiry date in a 2D bar code or data matrix and, part of it, in human-readable format. For the American market, serial numbers don’t have to be randomized. Another, more cultural than legal difference is the packaging format: traditionally pills in the US come in bottles rather than blisters and cardboard boxes. German pharma companies therefore require serialization solutions that can handle different packaging formats and printing masks if they want to produce for both, EU and US markets.
Only a fully configurable serialization solution can ensure permanent compliance with current and future regulations, leaving you the flexibility to quickly react to regulatory changes or conquer new markets. Central configuration also has the advantage that production lines get information about serial numbers and printing configuration directly from a central server, avoiding unnecessary hard coding and subsequent requalification on line-level.
Verification and Reporting System
In the European Union, authenticity will be guaranteed by an end-to-end verification system supported by risk-based verification carried out by wholesale distributors. This means that, unless there is doubt regarding a product’s authenticity, verification of medicines in the EU is only required at point of dispensation. Compared to the US, this sounds easy but will nevertheless have profound impact on the supply chain beyond the production lines: Wholesalers and 3PLs will have to adapt IT systems and establish business processes for decommissioning (which is not mandatory in the US) and risk-based verification whereas retail pharmacists and hospitals will need to integrate verification in workflows.
In the United States, verification is required once the product leaves the manufacturer all the way through the supply chain at each transfer of liability.
At each change of ownership, the previous owner is required to provide the new owner with certain types of transaction documents (T3: Transaction Information, Transaction History and Transaction Statement). The FDA can organize product investigations and manufacturers then have only 24h to respond to inquiries. German manufacturers will have to connect to the European Medicines Verification System EMVS in order to upload serialization and product master data. This European Hub will communicate information directly to the national repository managed by the stakeholder organization securPharm.
Keeping control of your serial number generation strategy from the start of the serialization project implementation is therefore key. Bigger organizations with multiple sites and/or CMOs should opt for a level 4 system linked to a strong, highly configurable level 3 system. Whether producing medicines for the American market or for the EU, manufacturers, especially large-scale ones, will need a serialization system that is able to communicate with enterprise-level systems (i.e. ERP, MES) and central databases. For Marketing Authorization Holders (MAH), safe connectivity with third parties like authorities and/or 3PLs incl. easy on-boarding is a must as well.