On May 18, the US Food and Drug Administration (FDA) posted the finalized guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.

This guidance document represents FDA’s current thinking on safe medication container label and carton labeling design and is intended to help minimize medication errors associated with drug and biological products. A draft version of the guidance had been available since April 2013 and was revised to the finalized guidance based on public input and information learned through reported errors over the years.

Some of the noteworthy additions or clarifications that were made since the release of the 2013 draft version include:

  • Ensuring consistency between the container label and carton labeling and other approved labeling (Section III.F)
  • Recommendations on displaying the established name for fixed-combination drug products (Section IV.A)
  • Additional approaches that can be considered with tall man lettering for similar-looking name pairs (Section IV.B)
  • Expression of strength for:
    • solid oral dosage forms (strength per unit vs. total contents or total dose) (Sections IV.C.2; V.A.2; V.J)
    • certain small-volume injection products, such as single-dose combination products, and exceptions to expressing strength as quantity per total volume (Section IV.C.3)
    • dry solid injectable products vs. dry solid oral products requiring reconstitution (Sections IV.C.4-5)
    • fixed-combination drug products (Section IV.C.6)
    • single-entity injectable products (Section IV.C.9)
  • Minimizing confusion between products intended for otic and ophthalmic administration (Section IV.D.1)
  • Warning statements for neuromuscular blocking agents (Section IV.E.1)
  • Expression of expiration dates to match USP General Chapter <7> (Section IV.F.1)
  • Beyond-use dates (Section IV.F.2)
  • Use and placement of linear barcodes and additional barcode risks, such as placement on the curvature of the container (Section IV.G)
  • Other container label and carton labeling considerations for large-volume injections, such as information to include on the label for nontransparent overwrap, cautionary statement for Sterile Water for Injection, and abbreviations with salts (Section V.D.3)
  • Product differentiation with large-volume injections, including techniques to call out important differences, such as for containers intended for different routes and hypertonic Sodium Chloride Injection (Section V.D.4)
  • Additional recommendations on:
    • transferable or peel-off labels for injectable medications, such as they should not overlay important information on the product label (Section V.E)
    • printing critical information on both the front and back panels of the label (Section V.F)
    • beyond-use date for pharmacy bulk packages (Section V.G)
    • measure markings on dosing devices for oral liquid drug products (Section V.I)
  • New sections on:
    • warning for single patient use of insulin pens (Section V.L)
    • container labels for diluents (Section V.N)
    • unit dose cups for oral liquid drug products (Section V.O)
    • transdermal and topical systems (Section V.P)
    • unit dose packaging intended for hospital use (Section V.Q)
    • infusion containers with hangers used for administration (Section V.R)

Med Safety Board can help life sciences companies meet these guidelines through our product labeling and packaging review and design services. Contact us to learn more about how we can help.