In June, the U.S. FDA extended the Product Identifier Requirements under the Drug Supply Chain Security Act (DSCSA)—resulting in some of the biggest changes in 2017 for manufacturers. The previous implementation timeline dictated that all manufacturers must have serialized products after November 2017. Now, however, manufacturers have a ‘hard’ deadline of November 2018. Until then, the FDA does not plan to take action against unprepared companies.
How do industry leaders feel about serialization? According to Applied DNA Sciences’ survey results, serialization hasn’t been inspiring quite the amount of enthusiasm as the FDA may have hoped and it’s considered insufficient on its own to protect patients from the threat of counterfeited products. Moreover, these experts reveal that packaging may be more vulnerable than we realize.
But compliance isn’t all doom and gloom. Some companies, such as Adents, have been thriving as they dive deeper into streamlining the big, bad process that is serialization. The company takes a deeper dive into Level 4 serialization, providing an oversight of how cloud-based solutions fit into the mix.
In one of my favorite pieces of this issue, contributing editor, Mike Botta, dove into braille in pharma. While the U.S. is often at the forefront of forming regulations and standard operating procedures, braille (as it turns out) is a relatively unheard of topic when it comes to packaging regulations. Specifically, the European Union countries require braille on pharmaceutical packaging, while the U.S. currently considers it to be optional. Tune in to Mike’s story to learn what an FDA spokesman, industry executives, and an advocate for the visually impaired had to say on the topic.