Most new prescribing information follows the Physician Labeling Rule (PLR) format set out in 21 CFR 201.56 and 201.57: Highlights of Prescribing Information, a table of contents, and Full Prescribing Information in a set order of sections. Older labeling uses the format in 21 CFR 201.80. FDA reviews and approves the text, and it is published in SPL form on DailyMed (see SPL). The EU equivalent is the SmPC.
Why it matters for labeling
Almost everything else is derived from the prescribing information: the carton text, the SPL file, the Medication Guide, and every promotional claim, which has to be consistent with the approved labeling. A single changed number, such as a dose or a contraindication, can make a derivative piece inaccurate, so each one has to be checked against the current approved version.
Common mistakes
- Derivative pieces built from an outdated version of the prescribing information
- Text that differs between the PDF and the SPL file
- Promotional claims that go beyond the approved indications
- A table, footnote or boxed warning lost in conversion