Beginning in 2005, the Food & Drug Administration began passing Structured Product Labeling (SPL) rulings that require pharmaceutical manufacturers to submit drug product labels in XML. Most recently, the FDA issued SPL R4, a revision to SPL that mandates that starting June 1, 2009, all product label content must be submitted by pharmaceutical companies electronically in XML.

This case study details how Par Pharmaceutical, led by its resident XML expert Michele Cobham, has maintained compliance with the FDA rulings around XML-based labeling, drug registration, and labeler code registrations by bringing the conversion and creation of XML content in-house with Quark XML Author for Microsoft Word, rather than using an outside service.