Information:

  1. Missing folder - Place each SPL document and any associated image file(s) in a folder and upload the folder containing the SPL and image files via the FDA Gateway’s “OC” directory.
  2. Incorrect or missing file extension – The file extension for SPL documents is “.” and the file extension for image files is “.jpg”.
  3. Incorrect file format – Winzip (zipped files) Excel, PDF, Word, and eCTD files are not acceptable formats for documents submitted for the purpose of electronically registering a drug establishment, submitting or requesting a NDC labeler code, or listing a drug product via the FDA OC Gateway. Only and JPEG (jpg) file formats are acceptable.
  4. Submitting more than one file per folder – Only one SPL file should be included in each folder.
  5. Incorrect SPL file name – Use the SPL document ID with the file extension “.”
  6. Not using the suffix element – Utilize the suffix element for any additional qualifiers (e.g. dosage form, route of administration, etc.) for proprietary names.

Additional notes:

  1. SPL Technical Q&A training sessions are held each Monday (except Federal holidays) from 11:30 a.m. - 12:00 - p.m., (Eastern Time Zone): Audio Conference details: Telephone number: 1-866-775-9435 - Participant pass code: 2219058
  2. Send SPL-related e-mails to the FDA SPL e-mail account: spl@fda.hhs.gov. Do not send SPL-related e-mails to both spl@fda.hhs.gov and lonnie.smith@fda.hhs.gov.
  3. Test your SPL R4 documents via the Pragmatic Validator Lite tool to detect 90 - 95% of the technical errors which will be detected by FDA SPL R4 validation procedures:
  4. The HL7 SPL Working Group has provided a hyperlink to the SPL Release Four Common Errors training slides: http://spl-work-group.wikispaces.com/file/view/common_errors_spl_r4_training.pdf.
  5. The HL7 SPL Working Group's OTC sub team has provided a hyperlink to an OTC SPL document template: http://spl-work-group.wikispaces.com/OTC.