Structured Product Label (SPL)
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 detailing the different sections as indicated by the FDA. The SPL is created with a list of acceptable terms or variables recognized by the FDA. The SPL is required as of October 31, 2005 for all label submissions 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 (registrars) when first engaging in the manufacturing, preparation, propagation, compounding, or processing of drugs (including human drugs, veterinary drugs, and biologic pharmaceuticals) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants must also submit registration information for their establishments on or before December 31 of each year.
Among the multiple formats of SPL sent, the most common formats are:
• NDC Label Application: This process involves the registration of a label that requires an NDC Code. This provides you with the NDC Code for a product. This NDC code is linked to Medication Requests.
• Establishment Registration: This process involves detailing the information of the establishment, such as the company name, address, contact details (email, phone number), website URL, etc.
• Product label: The product label includes all of the published material that accompanies a product, such as the actual label for a prescribed dose, as well as the package insert that contains a wealth of detailed information about the product. SPL documents contain both the labeling content (all text, tables, and figures) of a product as well as additional machine-readable information (drug list data elements). Drug list data elements include product information (product and generic names, ingredients, ingredient concentrations, dosage forms, routes of administration, appearance, DEA schedule) and packaging (quantity and type of package)
All FDA-approved SPLs are publicly available on the DailyMed website. This is a complete and up-to-date source of information that describes in detail the composition, form, packaging and other properties of pharmaceutical products.
Creating an SPL is a long and slow process. So it’s important to try to get it right the first time. Otherwise, any typographical errors, etc., will also carry over to the Product label, packaging inserts, etc. This is where MA can ensure that the SPL is internally reviewed and approved before it is submitted to the US FDA. Typically, the steps to create an SPL are:
1. Create an FDA ESG account.
2. Acquire 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. Send data for Establishment Registration
4. Request an NDC tag code
5. Submit the SPL of the specific product
The essential components of a product SPL are:
1. Labeling Content.
2. Product data elements
on. Product name
B. Dosage Form
against Route of administration
D. Ingredient (active/inactive/adjuvant)
me. DEA Hours
F. Product characteristics (color, shape, size, etc.)
gram. packaging
H. Marketing information (category, status, start and end dates)
3. Representative samples of cardboard/container labels.
4. Identity of the distributor and manufacturer (may not be disclosed) of the product.
5. SLIMAGE.
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 the package inserts and therefore the SPL is not only important to the regulatory teams, but is also critical to the labeling team.