# Presentation: 032605

## Structured Product LabelingatFDA

- Lisa Stockbridge
- June 27, 2005

## SPL Background

*DailyMed Initiative* - Critical national health initiative
- Top priority initiative in the FDA today
- Project planning started in April 2004
- Commitment to complete the first release by October 2005

- Mission: *Improve patient safety by ensuring that medication information is readily available to health care providers, patients, and the public, in its most up-to-date form*

## Mandates/Recommendations to Improve National Health Care

**Medicare Prescription Drug Improvement and Modernization Act of 2003**
- Requires uniform standards for medication information
- e-Prescribing
**Institute of Medicine**
- “Better management of health information is a prerequisite to achieving patient safety as a standard of care”
**National Committee on Vital and Health Statistics**
- Recommended the “adoption of uniform data standards for patient medical record information and the electronic exchange of such information”

## Daily Med Initiative

- Manufacturers and distributors collaborate with FDA to maintain detailed information about their products in an electronic form called Structured Product Labeling (SPL)

- Up-to-date SPL transmitted to the National Library of Medicine (NLM) on a daily basis

- NLM provides SPL and other medication information via an electronic repository called the *Daily Med*

*Daily Med* information is used in computer systems and decision support systems throughout the healthcare community

## Example

- Description:
- This is the description of the product
- Indications and Usage:
- This is the indication for use of this product
- Contraindications:
- These are the contraindications
- Warnings:
- These are the warnings.
- How supplied:
- This is how the product is supplied.

- PDF

- SPL

## SPL Sections

## SPL Drug Listing Data Elements

- Finished Dosage Form

- Active ingredient(s) strength and dose form

- Dosage form

- Color and shape

- Manufacturer

- Scoring

- Labeled route of administration (e.g., oral)

- Inactive ingredients

- Imprint code

## Overview of Information Flow

## SPL Program

- Phase I: SPL for approved prescription drugs
- Target: October 2005
- Systems
- Electronic Labeling Information Processing System (ELIPs)
- Substance Registration System (SRS)
- Regulations: ELR
- Standards: SPL, UNII, Medication Terminology
- Phase II – SPL for unapproved prescription and OTC drugs
- Target: August 2006
- Systems
- Electronic Listing System (eList)
- Drug Facility Registration Module (DFRM)
- Regulations: DLR

## Electronic Labeling Rule Implementation: June 8, 2004

- Submit content of label in electronic format
- pdf or SPL during transition phase
- After implementation of Phase I – SPL only
- Applies to content required under  21 CFR§201.100(d)(3)
- “Package Insert” or “Professional Labeling”
-  Includes all text, tables, and figures
- Allows FDA to process, review, and archive
- Store, retrieve, search, edit, compare, check status, export
- Within label versions for one drug or across labels

## Electronic Labeling Rule (cont.)

- In *addition* to requirements for the submission of all proposed labeling, copies of the formatted label, and specimens of final printed labeling (including labels, enclosures and containers)
- Labeling negotiations with review divisions may remain the same (e.g., WORD, fax, e-mail, etc.)
- FDA will issue periodic guidance updates on the method of transmission, media, file formats, preparation, and organization of files

## Transition Period

- Content of Labeling from PDF to SPL
- Begin – June 2004
- Completion – October 2005
- Regulations – Electronic Labeling Rule (ELR)
- Standards -  Structured Product Labeling
- Systems – Electronic Document Room

## Next Steps

- Healthcare Community Interests
- Medical devices
- Code sets similar to DPC and NDC
- Labeling for some products
- Dietary supplements
- Code sets similar to UNIIs, DPC and NDC
- Product descriptions (e.g., ingredients, packaging)
- Other steps
- Biologics, Veterinary Medicine

## SPL Notes

- HL7/SPL Release 2a will be baseline standard
- Testing with industry expected in August 2005
- Submit SPL in a single SPL folder
- One SPL per submission
- Whole label to be submitted
- Current SPL submitted on the anniversary of Annual Report (legacy labels get into system)

## FAQ

- What if I create my SPL incorrectly?
- If the SPL can be read by ELIPS, FDA will validate the SPL structure and data elements and work with industry to correct it.
- If the SPL cannot be read by ELIPS (i.e., there is no SPL in the SPL folder, the CD is broken, etc.), industry will receive an error report from FDA to resubmit. FDA will not have “received” the SPL.

## FAQ

- When will I have to submit SPL?
- Since June 8, 2004, submission of the content of labeling in electronic format was required as pdf or spl.
- When will the SPL format be required?
- When ELIPS is implemented (expected on October 31, 2005), SPL format will be required. FDA will notify industry of the date.

## FAQ

- What if SPL looks different from the Word document?
- The Electronic Labeling Rule requires that the content of labeling be submitted in SPL format. The stylesheet dictates how the content will look.
- Do we have to submit SPL for patient labeling?
- SPL is only required for the content of the physician labeling or package insert (PI).

## FAQ

- Do we have to submit SPL for each NDA or can we cross-reference?
- Individual SPL must be submitted with each NDA.
- Will the sponsor get to see the approved SPL before it is posted on the NLM website?
- The sponsor will get a copy of the approved SPL with the action letter.
- The sponsor may get the SPL XML file following approval if there is a secure e-mail established with the review division.

## Contacts

- www.fda.gov/oc/datacouncil/spl.html
- Questions
- Lonnie Smith (General) 	301- 827-7752
- Koung Lee (Generic Drugs)	301- 827-5846
- Program Management
- Rachel Behrman, Program Sponsor
- Randy Levin, SRS Sponsor
- Jim Shugars, IT Program Manager
- Lisa Stockbridge, Business Program Manager
- Colleen Ratliffe, SRS IT Project Manager
- Jonathan Cook, SRS Project Manager