Anatomy of a Compliant Drug Facts Panel

By Eric L. Foxman, R.Ph.

 

In my May 2020 article, The Anatomy of a Compliant Homeopathic Label, I covered:

• The importance of considering the intended use statements that will be placed on the label;
• An overview of labeling requirements from the HPUS;
• What 21 CFR requires on the PDP;
• For the traditional labeling format, what’s required on the Info Panel; and
• Three additional required statements, including the presence/absence of a disclaimer statement to conform with FTC substantiation standards.

This article will deal with the details of the Drug Facts Panel [DFP].

FDA had previously stated: “An express exemption would not be appropriate [for homeopathic drugs]. However the agency’s stated policy is that such products ordinarily will not be recommended for regulatory action if the product is a homeopathic drug as described in Compliance Policy Guide 7132.15 [since renumbered 400.400]… and the product follows the labeling and all other recommendations of that document.” However, with the withdrawal of CPG 400.400 [[1]], the ability to utilize the Traditional Labeling Format is suddenly in question. And the recently released Draft Enforcement Guidance includes nothing that can be construed as permitting the use of the Traditional Format instead of the DFP.

From a different perspective, the vast majority of consumers have become so used to seeing the DFP that one might wonder if the absence of this format might be a possible detriment to continued sales growth. Thus it is timely, for two reasons, to review and consider use of the DFP.

Placement of DFP

The Drug Facts Panel [DFP] and its Contents are required on every retail package of OTC drug products. If there is an outer package (folding carton, etc.), the regulations do not require (but FDA encourages) the DFP to also be placed on the immediate container.

The DFP should be on the side opposite the Principle Display Panel, and can continue onto an adjacent panel if necessary (see below). The DFP must be separated from everything else on the package by a graphic box or similar enclosure.

The text and required graphic elements must be in a single color (black is not specified) against a contrasting white or neutral background with no unapproved graphics within the DFP. No specific font is required, however the font must “be legible and clearly presented” with requirements for specified leading between lines and a maximum number of characters per running inch.

Categories

There are different categories (Headings) of information. The Heading must appear in a specified sequence and the rules for formatting are quite detailed. (If the DFP must be continued onto an adjacent side, the sequence must still be adhered to.)

Be aware: none the following is included in the Drug Facts Panel regulations and must not appear within the DFP. These types of information must appear elsewhere on the label:

• Disclaimer statement(s)
• Tamper Evident statement
• Explanatory statements [e.g. “The letters ‘HPUS’ indicate the component(s) in the product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.”]
• Other information required by regulation
• Country of Origin
• Any other promotional statements
• As noted above, no other graphics, including UPC symbols, are permitted in the DFP.

Formatting Considerations

• The first line of the DFP must state “Drug Facts” and has very specific formatting requirements.
• If the DFP continues onto an adjacent panel, that panel’s first line must be “Drug Facts (continued)”and comply with specific formatting requirements, which are similar for all subsequent headings.
• If the DFP continues onto an adjacent panel, a graphic “arrow” must direct the reader to which adjacent panel the DFP is continued upon.
• Hyphens are prohibited (except in a compound word).
• Bullets must be used wherever there is more than one statement within a heading. The bullets’ size is regulated; they must be uniform in color and shape and be vertically aligned. If there is more than one bullet on a line, they must be “uniformly spaced” and the text can not continue to the next line.
• Bar lines must be used to separate the label categories and they must run edge to edge (e.g.,. touch the outer graphic box).
• Hairlines are to be used to separate a title and the following category; may also be used between different statements within a category. Hairlines must be centered and extend to within two “spaces” of, but not touch, the outer graphic box.

What About Small Packages?

If the package is too small to fit the usual DFP, the regulations give the possibility for a Modified Format. This Modified Format can only be used if the usual DFP format would fill more than “60% of the surface area available to bear labeling.” The regulations explicitly state one must perform the calculation based on the minimum number of uses in Use category. Some of the modifications are: allowance to use smaller point sizes; bullets need not be vertically aligned, and bullet text may continue onto the next line. In addition, one need not enclose the DFP in a graphic box if it is visually separated from other labeling with a color contrast.

An in-depth description of the details of the DFP requirements — including the specifications for layout, formatting, font sizes, and required wording — can be found in 21 CFR 201.66. A review of actual regulations will also provide illustrations of the standard format, the standard format on more than one panel, the modified format, and even a DFP for a drug product marketed with cosmetic claims.

In addition, AAHP’s archived webinar, Homeopathic Labeling, provides a good overview of the details without getting lost in the regulatory language. This webinar is available on DVD.Tthere are also nine supplementary ‘handouts’, including and OTC Labeling Checklist from the AAHP office for $395 plus $15 S&H (discounted $100 for AAHP members).

 

[1] FDA Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Products May Be Marketed