Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard document used to exchange information about the product and facility. Get to know more about SPL, its requirements and benefits and more in this article.
What Is Structured Product Labeling?
The Structured Product Labeling (SPL) is a standard document approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. HL7 is a non-profit organization which is involved in the development of standards that is dedicated in providing a comprehensive framework and standards for the exchange, integration, sharing, and retrieval of electronic health information.
Requirements Of SPL In Pharmaceuticals
Conversion of the existing content into XML version
Narrative Labeling Content (Information regarding the safety and clinical use of the product)
Product Data Elements (Information regarding quality, pharmaceutical and packaging)
Maintenance of product Information in a consistent manner in all packages and labels promotional outlets etc.
Types Of Structured Product Labeling And Format
Types of SPL includes
Human Prescription Drug
Human OTC Drug
Animal OTC Drug Label
Bulk Ingredient
Establishment Registration
Establishment De-registration
Prescription Animal Drug Label
Prescription Medical Device Label etc. and many other types are also available
SPL Document Creation And Submission
SPL is created using Extensible Markup language (XML) which is relatively human-legible, machine readable and also the tags permit search of key information.
1) Generate an XML SPL File as per your submission needs (e.g. Product Label, Establishment Registration, NDC Labeler Code Request), by adding all the appropriate data such as DUNS Numbers, NDC Labeler Codes, etc.
2) Validate your XML SPL File online with a data validator.
3) Correct the errors, if any, and revalidate online until the data validator shows no error.
4) Submit your SPL XML File through your FDA Test Account.
5) If the FDA response is positive, then submit the SPL XML File to your FDA Production Account.
Types Of SPL Product Data Currently Exchanged
Drug Products
Human Rx Drugs – Prescription drugs for human use, covering both approved and unapproved products.
Approved & Unapproved Rx Drugs – Prescription drugs that have either received FDA approval or are marketed without formal approval.
Unapproved Medical Gases – Medical gases used in treatments but not formally approved by regulatory authorities.
Unapproved Homeopathic – Homeopathic remedies marketed without FDA approval, typically under enforcement discretion.
Human OTC Drugs
OTC Monograph Final – Over-the-counter drugs that comply fully with FDA’s final monograph standards.
OTC Monograph Not Final – OTC drugs that are marketed under a proposed or incomplete FDA monograph.
OTC Homeopathic – Non-prescription homeopathic treatments available to consumers without formal FDA approval.
Animal Rx Drugs
Approved Rx – Veterinary prescription drugs that have undergone FDA approval for animal use.
Unapproved Rx – Prescription drugs for animals marketed without FDA approval but under enforcement policies.
Animal OTC Drugs
Over-the-counter drugs intended for animal use, available without a prescription.
Regulatory Guidelines For SPL Electronic Format Submission
The FDA will not accept the Drug Registration and Listing in paper forms. So, the companies must submit NDC (National Drug Code) Labeler Code Requests, Registration Establishment Requests, and Drug Listing data in an electronic format via SPL submissions.
Companies that produce and distribute Rx (prescription) products, OTC products, and veterinary medicine products should submit an SPL file to register establishments that manufacture, package, analyze, import, or serve as a U.S. agent for the company’s products or components of the product (registration listing).
Companies should submit a different electronic SPL file (drug listing) for each product listing its composition and packaging information and providing its usage information.
Benefits Of Structured Product Labeling
The SPL contains up to date information about the product, it can be utilized to improve patient safety effectively. Rather than make duplicate submissions, applicants are then encouraged to refer to the SPL labeling file submitted through the electronic drug registration and listing system in making labeling updates to application under the content of labeling requirement.
Inclusion of indexing elements which are machine readable tags that can be added to product labeling to enable users to rapidly search and sort information in SPL. Ease of information exchange and availability in all computer systems is another benefit that SPL offers. Labeling information of prescription drugs is available at free of cost on the internet with the adoption of SPL by FDA.
Structured Product Labeling Services
SPL is intended for exchanging product and facility information with the main aim being patient safety. So, regulatory compliance and compliance with region specific labeling requirements and other requirements are mandatory. Lack of expertise in these areas can take this challenge to the next level.
Artixio Consulting, has a team of experts including clinical, safety professionals, medical writers, labeling managers, labeling operations experts that can provide you with structured product labeling services. Know more about us through info@artixio.com
Also Read: What Is Company Core Data Sheet (CCDS)?
FAQs About SPL
How does SPL ensure regulatory compliance?
SPL requires accurate and consistent maintenance of product information and other FDAs electronic submission requirements are also met by SPL which ensures regulatory compliance.
What software is used to create SPL files?
General purpose word processor or XML editor or SPL specific editing tools can be used. IBM Streams Studio, FDA X Forms, Educe Solutions and some other user-friendly SPL editing tools are commonly used for SPL creation and validation.
How are SPL submissions updated over time?
An annual requirement arises to either update the listings or certify that no changes have been made for drugs that were not initially listed or updated during the current calendar year. The period is October 1 through December 31 each year.
What are the common challenges in preparing SPL documents?
Common Challenges include XML formatting, maintaining product information updates consistently, and being in compliance with ever changing regulatory standards.
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