Section 510 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360, requires all registered pharmaceutical manufacturers to provide the FDA with a current list of all drugs that it produces, prepares, propagates, compounds or processes for commercial distribution.
Changes in the act, resulting from the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Joe Compton, Senior Director of Business Development and Alliance Management at Tjoapack, reports.
All identifiers and corresponding information is compiled to form the NDC directory, a repository of active and certified finished and unfinished drugs that have been submitted to the FDA.
The FDA is mandating new standardised NDC regulations for drugs sold in the US. Traditionally, a 10-digit code — with a varying (4-5)-(3-4)-(1-2) format, with each part representing the labeller, product and package, respectively — was adopted; however, maintaining the current system is no longer an option.
This was exemplified during the pandemic, which significantly increased the rate at which NDC codes were being used owing to the rapid increase in medication demand — and highlighted the possibility of a code shortage.
Announced in July 2022, the proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” will require NDC to codes follow a strict 12-digit 6-4-2 format.
Changing the adopted NDC format will significantly impact the pharmaceutical industry.
It will come into effect 5 years after publication to allow companies to develop and implement strategies to uphold this new system.
In addition, a 3-year transition period post-effect date allows leeway for businesses to comply and implement the new system into their current manufacturing processes.
The FDA is taking responsibility for altering current US drug listings, working to convert them into the new standardised NDC format by adding additional zeros (wherein the 6-4-2 format isn’t present). Code uniformity means that no time needs to be wasted converting NDCs between the FDA-imposed arrangement and other standardised formats.
Altering NDC regulations sets a global precedent for labelling strategies to be updated. As many processes rely on the NDC to track and identify drugs, including supply chain, manufacturing, prescribing and dispensing systems, a code shortage would impact the distribution of essential medication and result in drug shortages, which would be detrimental to patient health.
Although immediate benefits are not initially visible, this new regulation does offer the potential for new drug products to have an associated NDC in the future. It also allows product managers and downstream partners to evaluate and adjust, further improving current operational processes.
Packaging partners must also update current operating systems to comply with these new regulations.
One of the biggest impacts for pharma companies and their packaging partners is the change in the required number of global trade item numbers (GTINs), which means updating current practices to cater to the new FDA compliance, including updating
- hardware to ensure the correct equipment with the ability to print valid serialisation codes is on-hand
- software suites to become equipped with the latest tools (with the technical capability to compose and implement the unique NDC identifier)
- stock keeping units (SKUs) to efficiently track product inventory.
Working to effectively implement these new systems into current practices is imperative and can help to take serialisation processes to the next level, reinvigorating operations, enhancing efficiency and maintaining high-performance standards.
The assistance of a supportive packaging partner can ease this process. With expertise in regulatory compliance and procedures, a partner can help to ensure that manufacturing operations and supply chains are not disrupted, helping to maintain product visibility and identification and allowing the pharmaceutical industry to continue distributing vital medications to meet patient needs.
