On May 18, 2022, the FDA issued final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” In this guidance, the FDA provides a set of principles and recommendations to drug sponsors to ensure that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of human prescription drugs and biological products.
The guidance applies to prescription drugs marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA. The guidance does not specifically apply to over-the-counter (OTC) drug products, compounded products, marketed prescription products used in clinical or bioequivalence studies, or investigational products, but the recommendations outlined in this guidance may still be useful for such products.
As the guidance explains, product labels should communicate information that is critical to the safe and effective use of a medication and poor labeling design can contribute to medication errors (i.e., any preventable event that may cause or lead to inappropriate medication use or medication-related patient harm). Some examples of medication errors related to poor label design that have been reported include similarity among multiple product labels, distracting text or images that visually clutter the label, error-prone abbreviations on the label, difficult to read text on the label due to font size or style, and key information (e.g., product name, dosage form, strength) not prominently located and displayed on the container label.
In the guidance, the FDA recommends that the principal display panel (i.e., the panel of a container label that is most likely to be displayed to the end user) include the following critical information:
- Proprietary name, if there is one
- Established name or proper name
- Dosage form
- Product strength
- Route(s) of administration
- Warnings (if any) or cautionary statements (if any)
- Controlled substance schedule if the product is a controlled substance
In some cases, the FDA recommends that the frequency of dosing statements (e.g., once daily) also be considered for inclusion on the principal display panel but should not be included in the same location as, or immediately following, the product strength to avoid misinterpretation of dosing instructions.
Additionally, the FDA recommends that container labels and carton labeling should be legible, readable, and understandable. For instance, the drug product label should be sufficiently large enough to accommodate all the critical information, including the product’s proprietary name, lot or control number, name of manufacturer or distributor, product expiration date, and product strength. For biological products, at minimum, the label must include: the name of the product, lot number or lot identification, manufacturer name, and the recommended individual dose for multiple-dose containers.
The guidance also recommends a larger font size, such as 12-point font, and fonts that are not lightweight, such as Arial, to improve readability of the container label. Further, sponsors should avoid color combinations that do not afford adequate legibility of text (e.g., pale yellow text on a white container label background) and should consider the substrate of the container label (e.g., matte versus gloss finish), which could also impact legibility. Last, the guidance explains that a container label should not be overcrowded with information and should not contain abbreviations, acronyms, or symbols that could be easily misinterpreted (e.g., µg for microgram should not be used because it could be mistaken as mg, meaning milligram).
Look-alike containers should also be avoided, and there should be consistency between the container label and carton labeling and other approved labeling. The guidance also emphasizes maximizing the readability of proprietary, established, and proper names on the container label. For drug products, the established name should be displayed with the finished dosage form.
Of particular importance to the end user is the product’s strength, which could result in the wrong dose being administered if read incorrectly. Accordingly, the FDA recommends, for example, that the product strength and designation stand out (e.g., a prominent typeface or type weight and color differentiation), routes of administration be described without abbreviation, and expiration dates be consistently formatted. Finally, the guidance provides considerations for other special container labels and carton labeling, including, but not limited to, blister packs, large-volume injections, pharmacy bulk packages, and product samples.