May 3, 2006

The FDA's Center for Drug Evaluation and Research (CDER) has released a draft technical document on how to use structured product labeling (SPL) Release 2, which incorporates changes in the requirements for the content and format of labeling for human prescription drug and biological products.

The details for these changes are in the final rule published in the Federal Register on Jan. 24, 2006. Among other things, the rule revises labeling regulations to require inclusion of "Highlights" and a table of contents for the full prescribing information (FPI). In this part of the SPL, pharmaceutical manufacturers will be required as of June 30 to use the "Problem List" subset of the Systematized Nomenclature of Medicine (SNOMED) to code important terms if their product is newly approved or has been approved within the last five years. In addition, some of the labeling sections in the FPI have been reorganized. The scope of the new document is limited to submission of SPL to the FDA.

The highlights of SPL are supposed to come from three sources: boilerplate text rendered directly from the stylesheet (e.g., "Highlights of Prescribing Information"), data elements inserted into the boilerplate text (e.g., year of initial U.S. approval) and text blocks corresponding to each major part of the highlights. These include boxed warning, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations and patient counseling information.

The draft technical document can be seen here: http://www.fda.gov/cder/regulatory/ersr/SPL/Draft_SPL_Highlights.pdf (http://www.fda.gov/cder/regulatory/ersr/SPL/Draft_SPL_Highlights.pdf)