Regional Labeling USA: An Overview

To help clients meet USA Regulatory labeling requirements, Freyr's specialized Regional Labeling USA service involves converting current labeling content into the required Structured Labeling (SPL) format, adhering to Physician Labeling Rule (PLR) Compliance and Drug Registration and Listing. This process involves a comprehensive review and careful reformatting of the information to fit the structured requirements outlined by the FDA. By converting the content into SPL format, Freyr ensures that the drug labeling complies with the FDA's strict regulations, which helps expedite the approval and listing process.


Regional Labeling USA - Freyr Expertise

New Chemical Entity (NCE)

US Prescribing Information (USPI) and US Patient Prescribing Information (USPPI), Medical Guides (MG).

  • Physician Labeling Rule (PLR) Conversions

PLR is intended to provide healthcare professionals with clear and concise prescribing information and to better manage the risks of medication use and reduce medical errors. It also makes prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

Bound by a federal mandate, the USFDA has required that all NDAs, BLAs, and Efficacy Supplements submitted after June 30, 2006, conform to the SPL-PLR rule. In addition, all NDAs, BLAs, and Efficacy Supplements that are approved after June 30, 2001, must be converted to the SPL-PLR format during a seven (07)-year implementation period.

  • Pregnancy Lactation Labeling Rule (PLLR) Conversions

Recent changes to the FDA drug labeling requirements for pregnant and lactating women make prescribing more complex than it used to be, but the information will be far more complete and much more current.

The new PLLR has been designed to help prescribers assess the benefits and risks of medication for pregnant and lactating women. In contrast to the old system, the prescribers have used letter categories — A, B, C, D, and X — to evaluate the safety precautions.

The PLR is intended to make information on prescription drugs easier to read. For example, labels now include a "highlights" section containing bulleted information, a table of contents, warnings in bold font, and other useful information. However, the rule only applies to products approved under a New Drug Application (NDA), Biologics Licensing Application (BLA), or Efficacy Supplement (ES) between 2001 and June 30, 2006, as well as all products thereafter.

  • Structured Product Labeling (SPL)

The FDA mandates the filing of product labeling information in the SPL format. Many pharmaceutical developers, therefore, have determined the need for a reliable service provider that will enable their companies to meet the Regulatory compliance guidelines without straining their current business practices.

Depending on the context, Freyr recreates or efficiently utilizes your current labeling content and transforms this readily available content into the required SPL R4 or Physician’s Labeling Rule compliant format.

  • Generic Molecules
    • Reference Listed Drug (RLD) label change monitoring.
    • Annotated PI and carton labels.
    • Side-by-side label comparison - US Prescribing Information (USPI), USPPI, and MG.
    • Clean PI and carton labels.
    • Label change monitoring.
    • SPL Conversion.

While assisting applicants and manufacturers in adhering to diverse FDA labeling requirements, Freyr also provides other Regulatory services related to label submissions including:

  • Drafting/creating US Package Insert (USPI).
  • Drafting/creating US Medication Guide (USMG).
  • Biosimilar product labeling/tracking.
  • Abbreviated New Drug Application (ANDA) labeling.
  • Monograph labeling – OTC.
  • HA Query management.
  • Annotated labeling for Innovative and Generic drug applications.

Meet Your Regulatory Labeling Requirements in the USA


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