Structured Product Label refers to the electronic document to be submitted by Manufacturers for Drug establishment registration and Drug listing information to US FDA. The electronic document is in XML format with a pre-defined structure detailing the different sections as indicated by FDA. The SPL is created with a list of acceptable terms or variables as recognized by FDA SPL has been mandated since 31-Oct-2005 for all labeling submissions to the FDA’s Center for Drug Evaluation and Research (CDER). This is a FDA initiative to improve patient safety through better access to product information.
Manufacturing companies (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Among the multiple formats of SPL submitted, the most common formats are:
- NDC Label Request: This processes involves the registration of a label which requires a NDC Code. This provides you with the NDC Code for a product. This NDC code is linked to the Drug Applications.
- Establishment Registration: This process involves detailing the Establishment information, like Company name, Address, Contact Details (email, phone number), Website URL etc.
- Product Label : The product label includes all published material accompanying a product, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the product. SPL documents contain both the content of labelling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type)
All FDA approved SPLs are publicly available from DailyMed (https://dailymed.nlm.nih.gov/dailymed/ ) website. This is a comprehensive and up to date source of information describing the composition, form, packaging, and other properties of the drug products in detail.
To create an SPL is a lengthy and time consuming process. So it’s important to try and get it right the first time. Else any errors like typo etc also will be carried forward to the Product label, Packaging inserts etc. This is where ManageArtworks can ensure that the SPL is reviewed and approved internally before submitting to the US FDA. Usually the steps to create an SPL are:
- Create an FDA ESG account.
- Acquire a DUNS number. Dun & Bradstreet (D&B) provides a D-U-N-S Number, a unique nine digit identification number, for each physical location of your business.
- Send details for Establishment Registration
- Request a NDC Label Code
- Submit the specific Product SPL
The essential components of a Product SPL are:
- Content of Labeling.
- Product Data Elements
- Product Name
- Dosage Form
- Route of Administration
- Ingredient (active/inactive/adjuvant)
- DEA Schedule
- Product characteristics (color, shape, size, etc…)
- Marketing Information (category, status, start and end dates)
- Representative samples of carton/container labels.
- Identity of distributor and manufacturer (may not be disclosed) of product.
US FDA provides the XML standard. SPL gives accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format. SPL acts as the source document for Pack Inserts and thus, the SPL is not only important for the Regulatory Teams, but also critical for the Labeling Team.