Structured Product Label refers to the electronic document that manufacturers must submit for drug establishment registration and drug listing information to the US FDA.The electronic document is in XML format with a predefined structure that details the different sections as directed by the FDA. The SPL is created with a list of acceptable terms or variables recognized by the FDA. The SPL has been mandatory since October 31, 2005 for all label shipments to the FDA’s Center for Drug Evaluation and Research (CDER). This is an FDA initiative to improve patient safety through better access to product information.
Manufacturing companies (registrants) when engaging for the first time in the manufacture, preparation, propagation, compounding or processing of drugs (including human drugs, veterinary drugs and biological pharmaceuticals) to register their establishments and submit listing information for all medicines in commercial distribution. Registrants must also submit their establishment registration information on or before December 31 of each year.
Among the multiple SPL formats sent, the most common formats are:
• NDC label request: This process involves registering a tag that requires an NDC code. This provides you with the NDC code for a product. This NDC code is linked to drug applications.
• Establishment record: This process involves detailing the establishment information such as company name, address, contact details (email, phone number), website URL, etc.
• Product label: The product label includes all the published material that accompanies a product, such as the actual label at a prescribed dosage, as well as the package insert that contains a wealth of detailed information about the product. SPL documents contain both the content of the labeling (all text, tables and figures) of a product and additional machine-readable information (data elements of the drug list). The drug list data elements include information about the product (generic and product names, ingredients, ingredient concentrations, dosage forms, routes of administration, appearance, DEA schedule) and packaging (quantity and type packaging)
All FDA-approved SPLs are publicly available on the DailyMed website. This is a comprehensive and up-to-date source of information that describes the composition, shape, packaging, and other properties of pharmaceutical products in detail.
Creating an SPL is a long and time-consuming process. That is why it is important to try to get it right the first time. Otherwise, errors, such as typographical errors, etc., will also carry over to the Product label, packaging inserts, etc. This is where MA can ensure that the SPL is reviewed and approved internally before submitting it to the US FDA. Generally, the steps to create an SPL are:
1. Create an FDA ESG account.
2. Purchase a DUNS number. Dun & Bradstreet (D&B) provides a DUNS number, a unique nine-digit identification number, for each physical location of your business.
3. Submit details for establishment registration
4. Request an NDC tag code
5. Submit the SPL for the specific product
The essential components of a product SPL are:
1. Content of the labeling.
2. Product data elements
to. Product name
B. Dosage form
vs. Administration path
D. Ingredient (active / inactive / adjuvant)
me. DEA schedule
F. Product characteristics (color, shape, size, etc …)
gram. packaging
h. Marketing information (category, status, start and end dates)
3. Representative samples of carton / container labels.
4. Identity of the distributor and manufacturer (may not be disclosed) of the product.
5. SPLIMAGE.
The US FDA provides the XML standard. SPL provides accurate and up-to-date drug information using standardized medical terminology in a readable and accessible format. SPL acts as the source document for package inserts, and therefore SPL is not only important for regulatory teams, but also critical for labeling equipment.
