What Is Structured Product Labeling (SPL)?
Structured Product Labeling aims to improve patient safety by facilitating the exchange of product information among organizations within the healthcare industry.
Imagine what traffic must have been like before standardized traffic lights. It wasn’t until 1920 that Detroit erected the first four-way traffic light of three colors: red, yellow and green. The innovation of the yellow light gave traffic police the time they needed to change the light colors and keep traffic moving. Once standardized in the U.S., traffic lights provided safety, predictability and reliability.
Likewise, the standardization of Structured Product Labeling has been a boon in electronically communicating product and drug information. Structured Product Labeling (SPL) is the FDA-required standard for formatting product and drug information, enabling data exchange in a consistent and machine-readable format. In addition, having a single format enables automated data processing and faster information retrieval.
As a standard format, SPL facilitates the exchange of product and drug information between manufacturers, the U.S. Food and Drug Administration (FDA), healthcare providers, regulatory agencies, payers, and other stakeholders. As a result, every drug’s information is comprehensively presented and consistently organized in one file.
In October 2005, the FDA said the Center for Drug Evaluation and Research (CDER) could only handle electronic SPL files in extensible markup language (XML). Over the years, the FDA has mandated that SPL submissions are necessary for all pharmaceuticals (human and veterinary) and biologics. SPL communicates accurate and clear product information that’s consistent with FDA-approved labeling and other applicable standards. It also ensures that healthcare professionals and patients can easily and accurately access product information.
SPL documentation, using the Health Level Seven International (HL7) standard, contains the following elements:
- Content of Labeling
- Product data elements like the product name and dosage form
- Route of administration
- Active, inactive and adjuvant ingredients
- DEA schedule
- Product characteristics like color, shape and size (for example)
- Packaging information
- Marketing information like the category, status, start and end date
- Representative samples of cartons or containers
Goals of SPL
While SPL serves various functions, its main goals are to:
- Improve patient safety by providing accurate, up-to-date product information
- Provide product labeling information in a timely and accurate manner
- Make it easier to review, store, and distribute labeling content
- Ensure labeling content is in a human-readable and machine-processable format
And in order to achieve these goals, pharmaceutical companies have to comply with requirements established by the FDA.
General SPL Requirements
SPL requirements provide an organized and consistent way to present product information and labeling content that the FDA requires. Here are some general SPL requirements:
- Convert all labeling content into XML format.
- Ensure all XML content is compliant with validation rules created and published by the FDA.
- Submit any narrative labeling content and drug listing information to the FDA.
Benefits of SPL Documentation
Developing and implementing standardized SPL opened various opportunities to index the information using machine-readable tags. These tags now allow organizations to incorporate SPL information into electronic health records. The indexing has been used to improve e-prescribing systems. Additionally, this tagging facilitates searchability: Clinicians can now search for, sort through, and access information about medications when making critical medical decisions.
As part of the FDA’s initiative to improve patient safety through better access to product information, another benefit of structured product labels has been the online distribution of this information via the DailyMed, a part of the National Library of Medicine website. The DailyMed provides up-to-date, free access to consumers to all of the FDA-approved SPLs.
7 Types of FDA SPL Files
There are several types of SPL files that pharmaceutical companies send to the FDA in order to get their drugs approved for market.
1. Drug Listing (FDA)
Drug establishments must submit product registrations and listings to the FDA in order to register their drugs and National Drug Codes (NDCs) for sale in the U.S. These files include information about the labeler, facility, active and inactive ingredients, application numbers, packaging configurations, and content of labeling. The information is then included in the National Library of Medicine’s DailyMed repository.
2. Establishment Registration
The FDA requires all U.S. drug manufacturers to register with them. Each establishment needs to include the manufacturer’s address and contact information, importer and U.S. Agent information, and details of the business operations. Only one establishment can be included in a single registration, even if the registrant has multiple establishments.
3. NDC Labeler Code Request
The National Drug Code (NDC) is a three-segment number used by the FDA to uniquely identify and report products. The first segment of this Code is the Labeler Code, which is assigned by the FDA and signifies the Labeler entity that owns the product or markets it under their name or the establishment/facility that produces it. This Code is obtained and maintained by submitting NDC Labeler Code files to the FDA.
4. Lot Distribution Report
The Lot Distribution Report (LDR) SPLs for biologic drugs must be submitted to CBER every six months unless a waiver is granted for annual submission. These reports include the bulk, package, and label lot data, as well as the bulk manufacturer and the same product data elements that are included in the drug listing file. The LDR also lists all packages distributed during the reporting period.
5. Wholesale Drug Distributor/Third-Party Logistics (WDD/3PL) Registration
Every year, the FDA requires Wholesale Drug Distributors (WDD) and Third-Party Logistics Providers (3PL) to submit an SPL file that includes their license information for each state they conduct business in. If the same facility operates as both of these, they can use the same file, but they must enter the license number for each operation, even if it is the same in both.
6. GDUFA Self-Identification
Human generic drug facilities must annually submit both an Establishment Registration file and a GDUFA Self-Identification SPL file in order to be registered with the Generic Drug User Fee Amendments (GDUFA). The GDUFA file contains comparable information to the Establishment Registration. However, due to the dissimilar operations, a separate file is necessary.
7. Blanket No Change Certification
In order for a product to remain certified with the FDA, its listing information must be updated based on any changes or recertified using a Blanket No Change Certification (BNCC) SPL file. This file can only be used for drugs that have not been altered since the last submission and if SPL submission has passed the current validation procedures. If an NDC Code hasn’t been submitted through either of these methods during the current calendar year, the product and its NDC Code(s) will no longer be certified starting on January 1 of the following year. All expired listings will be taken off the NDC Directory and cannot be sold or marketed until the information is fixed.
Like the yellow traffic light, the implementation of the SPL standard has helped improve the safety, predictability and reliability of drugs for countless patients. It also gives pharmaceutical companies a clear blueprint for the information they need to provide the FDA in order to get their drugs approved for market.
SPL Portal by Intagras empowers pharmaceutical companies to create and submit SPL files with ease. Create compliant and error-free SPL files for all FDA electronic registrations and listing regulations. Contact us to start your journey with SPL Portal.
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