Implementing FDA’s Electronic Labeling Proposal

Pharmaceutical Technology
Aug 01, 2015
By Bindu Narang, Sciformix Corporation
Volume 39, Issue 17

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

For biopharmaceutical companies, product labeling is a highly regulated and complex process that is an integral part of their overall quality system. This already complex process is exacerbated even further with the announcement of the proposed electronic labeling ruling. A product with a wide geographical footprint requires labels in each country or region to comply with the requirements of local regulatory agencies. Requiring electronic labeling increases the risk of having inconsistent information across labels of the same product.

FDA proposed a new rule in December 2014 to amend its prescription drug and biological product labeling regulations. The rule applies to the electronic distribution of package inserts (PIs), which are currently provided in paper form with drug packaging for the benefit of healthcare professionals (HCPs) and consumers. The PI contains the latest information about the approved uses of the prescription drug or biological product, as well as information necessary for the safe and effective use of the product. When biopharmaceutical companies market their products in the United States, they will be required to provide the PI in an electronic file and will no longer be allowed to distribute it in paper form with the packages. FDA has proposed an effective date of six months after the publication date of the final rule in the Federal Register and a compliance date of two years after the date of publication of the final rule to give manufacturers time to comply.

Organizations need to find a way to fit the proposed change into their strategic labeling initiatives aimed at improving operational efficiencies and profitability, while reducing complex and disjointed processes.

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