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Best Practices: Cutting Through the Confusion & Avoiding the Pitfalls of Creating Files for SPL & ACA6004
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Best Practices: Cutting Through the Confusion & Avoiding the Pitfalls of Creating Files for SPL & ACA6004


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The FDA is making available resources to pharmaceutical companies to improve the quality of their submitted drug product information and using the Structured Product Labeling (SPL) validation rules to …

The FDA is making available resources to pharmaceutical companies to improve the quality of their submitted drug product information and using the Structured Product Labeling (SPL) validation rules to ensure the accuracy of that information as well as the content of labeling. This presentation will focus on how to use these resources to prepare accurate data for drug submissions. To cite just one example, the FDA has identified the active moiety and basis of strength for over 13,000 active ingredients and made that information available in an Excel file and in an XML; the active moiety and basis of strength in a submission is validated against that information and a validation error is issued if the submission information is incorrect. Other examples will be included in the presentation. Likewise, the FDA now requires pharmaceutical manufacturers and distributors to report their distributions of drug samples under the Drug Sample Transparency Act (ACA 6004) specification. Like SPL, reporting is done using XML and through the FDA’s Electronic Submissions Gateway. The new requirements for medical device manufacturers will also be discussed.

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  • 1. Howard Shatz, SPL Project Manager, Data Conversion Laboratory Best Practices: Cutting Through the Confusion & Avoiding the Pitfalls of Creating Files for SPL & ACA6004 Thursday, May 8, 2014
  • 2. Experience the DCL Difference DCL blends years of conversion experience with cutting-edge technology and the infrastructure to make the process easy and efficient. • World-Class Services • Leading-Edge Technology • Unparalleled Infrastructure • US-Based Management • Complex-Content Expertise • 24/7 Online Project Tracking • Automated Quality Control • Global Capabilities
  • 3. Valuable Content Transformed • Document Digitization • XML and HTML Conversion • eBook Production • Hosted Solutions • Big Data Automation • Conversion Management • Editorial Services • Harmonizer
  • 4. We Serve a Very Broad Client Base . . .
  • 5. . . . Spanning All Industries • Aerospace • Associations • Defense • Distribution • Education • Financial • Government • Libraries • Life Sciences • Manufacturing • Medical • Museums • Periodicals • Professional • Publishing • Reference • Research • Societies • Software • STM • Technology • Telecommunications • Universities • Utilities
  • 6. Our Presenter • Howard Shatz, DCL’s SPL Project Manager since 1991. • Active in SPL since its development began in 2003. • Active member of the SPL Working Group, composed of pharmaceutical companies and conversion vendors. • Frequent contributor to the SPL Working Group Wiki discussion forum. • He serves on the Process Communications, Establishment Registration/Drug Listing, and OTC subteams. • He has a BS in Computer Science from New York University. Prior to joining DCL, Howard was an account manager at EDS.
  • 7. DCL’s Life Sciences Offerings • Structured Product Labeling (SPL) Conversion and Submissions • SPL Consulting and Training • ACA 6004 Drug Sample Reporting Conversion and Submissions • Technical and Compliance Document Management ⁻ Document Management Consulting ⁻ Data Conversion Services
  • 8. Objectives of This Session • Explain how to minimize the pitfalls of Structured Product Labeling (SPL) and Affordable Care Act 6004 Submissions • Demonstrate how regulations can be enforced and accuracy of needed information can be validated through electronic submission
  • 9. Structured Product Labeling
  • 10. Accurate Labeler, Registrant, and Establishment Information • Labeler- Either the distributor or manufacturer of the product. Must use the DUNS Number used to register the NDC Labeler Code used in the file. Labeler codes and names of companies (but not DUNS Numbers) to which they are registered can be checked can be checked through the FDA’s SPL Resources page ( Foreign manufacturers must list the products they manufacture for US distributors in order to have the products imported • Registrant – Should be used only by manufacturer preparing the SPL for the private label distributor of the product (e.g. CVS, Walgreens, Rite Aid) • Establishment Information - Must use the DUNS Number used to register the establishment and operations it is registered for. Current registration of the establishment, including its DUNS Number but not its operations, can be verified at the FDA’s Drug Establishment Current Registration Site (
  • 11. Accurate Drug Product Information • Proprietary name • Established name • Ingredients • Preferred Substance Name • UNII • Strength • Basis of Strength • Active Moiety • Dosage Form • Labeled Route(s) of Administration • Physical characteristics • Color • Shape • Size • Scoring • Imprint
  • 12. Accuracy in Proprietary Name & Established Name • Proprietary name – This is the trademarked name of the product, if it has one, otherwise it’s the established name and should avoid including dosage form and quantities. In the XML tagging you can indicate a part of the name that is just descriptive, not proprietary (such as Lavender Scent) • Established name – Generally this is the active ingredient(s) unless instructed by the FDA (such as flu vaccines)
  • 13. Accuracy in Ingredient Information • Two sources to get it right – • FDA Substance Registration System search page ( – Use this page to get the Preferred Substance Name and UNII (Unique Ingredient Identifier) • FDA’s Active Ingredient-Active Moiety Relationship/Basis of Strength file (available in Excel and in XML). Retrieve it using the FDA’s SPL Resources page ( t.htm). Use it to get the expected active moiety for the active ingredient and the expected basis of strength (active ingredient, active moiety, or reference drug). • Ingredient strength – Only needed for active ingredients, expressed using appropriate units of measure (like grams for mass and liters for volume). If ingredient is a powder in a vial or syringe to be mixed with a diluent at a strength to be determined by the health care provider (such as when the dosage amount is based on patient’s age) then the strength is just the mass in the syringe or vial.
  • 14. Accuracy in Other Drug Product information • Dosage form, labeled route(s) of administration, and Physical Characteristics of Color and Shape – The values for these are controlled terminology terms accessible from the FDA’s SPL resources page ( The FDA permits use of non-controlled terms for color and shape in addition to the controlled terms. For example, an aqua blue pill you must use the controlled term “blue” but can also express as “aqua blue” • Physical characteristics of size, scoring, and imprint – • Size – Longest dimension in mm • Scoring – Number of pieces a pill can be cut into using score marks (starting with 1 if no score marks) • Imprint – Letters and numbers imprinted on a pill • Physical characteristics are needed only for products in oral solid dosage forms (tablets, pills, capsules). The information is beneficial to the public; as an example, if an unknown pill is found there are search pages, such as, where the pill can be identified by entering its physical characteristics.
  • 15. Accurate LOINC Codes for Sections • LOINC (Logical Observation Identifiers Names and Codes) in SPL identifies specific types of sections in the content of labeling. A LOINC is specified two ways in a section, once as a code and once as a standardized value. • Available LOINCs are found on the FDA’s SPL Resources page ( • Uses of LOINCs • Validation - Identify mandatory missing sections, including medication guides. • Searching - Look for text only in particular section • Label comparisons – Compare specific sections in labels. For example, one published study analyzed sections marked as Black Box Warnings and calculated how many were mismarked.
  • 16. Accurate information for ACA 6004 • Section 6004 of the Affordable Care Act requires that manufactures and distributors annually summarize their distribution of drug samples to health care providers, reporting a calendar year’s distribution summary by April 1 of the following year The FDA is not yet enforcing this part of the act, pending the issuance of further guidance, but submissions are being accepted. • Documentation is found using links at • There is limited validation that can be done but for the most accurate summary companies should ensure that information on the individual distributions be standardized. For example, the address for an individual doctor should be entered consistently; don’t specify the address as 123 Main Street in one record and 123 Main St, Suite 201 in another.
  • 17. Accurate Information for GUDID/UDI • By June 23, 2014 request for an extension for compliance with the September 24, 2014 compliance date for Class III Medical Devices (see below) must be submitted under § 801.55 • Beginning September 24, 2014: • Class III Medical Devices licensed under the Public health Service Act (PHS Act) must: • Bear a Unique Device Identifier (UDI) with dates on the labels of these devices formatted as required by § 801.18 • Have its data submitted to the Global Unique Device Identifier Database (GUDID) • Class III stand-alone software must provide its UDI as required by § 801.50(b). • Documentation is found using links at n/default.htm.
  • 18. Useful SPL Links & FDA Contacts DCL SPL Page FDA SPL Resources DailyMed FDA Online Label Repository Drug Establishments Current Registration Site FDA Substance Registration System search page CFR Title 21 on-line SPL Working Group Wiki (forums and documentation)
  • 19. Useful SPL Links & FDA Contacts (continued) Drug Nomenclature Monographs (links to monographs that define FDA terms, some terms may not be allowed in SPL) bmissions/DataStandardsManualmonographs/ucm071650.htm Status of OTC Rulemakings CounterOTCDrugs/StatusofOTCRulemakings/default.htm Pragmatic Data Validator Lite FDA SPL Group FDA Drug Registration and Listing System FDA Active Ingredient-Active Moiety Relationship/Basis of Strength (click on the link, open the zip file, open the spreadsheet) p FDA OTC Monograph - Active Ingredient (click on the link, open the zip file, open the spreadsheet) p
  • 20. Q&A Howard Shatz SPL Project Manager, Data Conversion Laboratory (718) 307-5719