Serialization: Optimizing Planning and Implementation

Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. To combat this problem in the U.S., the FDA has outlined requirements to make every unit of saleable prescription drug products traceable.

Meeting the requirements for these regulations requires a long-term strategy and preparation. Recro Gainesville, understanding the changing manufacturing landscape, began this process years in advance.

Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and management.

For companies that are using product serialization numbers, this early adoption has provided an important opportunity to develop and fine-tune their serialization processes before the FDA starts enforcing the rules in November 2018. One lesson that companies have learned is that implementing serialization can take longer than expected. Consequently, it is critical to initiate the process sufficiently before the implementation deadline to ensure that all the kinks are worked out.

Ultimately, failure to comply with the serialization requirements could result in penalties and potentially the inability to ship and sell unserialized products within the U.S.

Rather than delaying the inevitable, pharmaceutical companies can and should use this extra time to establish compliant serialization solutions with a partner that can help increase their supply chain efficiency.

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