Structured Product Labeling (SPL R4)

NDC Labeler Code Request (replaces Form 2656)
Establishment Registration (replaces Form 2656)
Product Listing/Labeling (replaces Forms 2657, 2658)

Do not get startled by reading this. Yes, this is true; US FDA is taking a firmer step towards providing sufficient and accessible information to patients and physicians. As a result of which manufacture of pharmaceutical ingredients and their marketing require a number of regulatory approvals.

The complexity and the proliferation of the regulatory standards have made submissions a time-consuming task. Above all, Structured Product Labeling has been mandated by US FDA as the only accepted method for electronic submission of drug labeling content for original submissions, supplements and annual reports. Also, SPL has started being used to exchange information needed for other submissions, such as, drug listings. This approach is practical and effective in order to streamline pharmaceuticals and its marketing within the entire United States. Technically, an SPL is a schema governed electronic document based on the HL7's (Health Level Seven) Clinical Document Architecture (CDA).

Our Work Flow

Speed up your submission process using Sarjen's services. Immaculate accuracy has added innumerable SPLs to Sarjen's credit. Hence, Sarjen with its dedicated employees understands the intensive endeavour of getting such approvals. The transition is cumbersome to understand but the precision with which SPLs at Sarjen are prepared is appreciated by all of its clients.