Pharmaceutical and
Medical Packaging News Magazine
PMPN Article Index
Originally published February 2001
FDA Sheds Light on Drug Labeling
Two published guidances aim to clarify presentation issues with over-the-counter drug labeling.In an effort to clarify certain aspects of the over-the-counter (OTC) drug labeling regulations taking effect in 2002, FDA published in December a finalized version of one guidance and a draft of another.
The finalized guidance, "Labeling OTC Human Drug Products Using a Column Format," does not adopt most of industry's proposals to allow greater use of columns within the new standardized format, but it does clarify some presentation issues.
The draft guidance, "Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals," makes it clear that exemptions will be few and far between, and that if a new package is required to accommodate the regulation, so be it. The guidance does anticipate the granting of deferrals for some products that will need extensive packaging changes, and it clarifies the procedure for requesting an exemption or deferral.
After the column-format draft guidance was issued in November 1999, the agency received a number of suggestions from industry on formatting. Two of these suggestions, allowing for more than one Drug Facts box on the same side of a package and providing alternative ways to present Active Ingredient and Purpose information on narrow panels, were accepted. Most of the other industry proposals, from eliminating the Drug Facts headings for second and subsequent boxes to allowing without restriction the use of columns within a single Drug Facts box, were usually rejected on the grounds of being confusing to the consumer.
The finalized guidance says that using more than one Drug Facts box on a single side of a container or using side-by-side boxes on a wraparound label is "consistent with the rule, provided it is done in a manner that allows for the clear and legible presentation of all required labeling information."
When using two or more Drug Facts boxes on the same side of a package, the right side of the first box and the left side of the second box can share a common vertical hairline. However, the boxes, enclosures, or columns should be approximately the same size. A visual graphic such as an arrow should appear at the bottom of the first box to direct the reader to the second box. Other provisions in the guidance aim to maximize the amount of open space within the Drug Facts box, which generally increases readability.
The draft guidance on exemptions and deferrals outlines what should be included in an application for exemption or deferral and the standards the agency will use to review them. Applications should include:
- A description of the product and the relevant SKUs.
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An itemized list of the specific provisions under 21 CFR 201.66(c) and (d) for which an exemption or deferral is being requested, and an explanation of why it is appropriate.
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A copy of the most recently marketed product labeling if applicable, and in most cases, a labeling mock-up to help illustrate why a specific requirement might be inapplicable or impracticable.
Response time is expected to be 30 to 60 days for straightforward requests and 120 to 180 days for requests presenting new or complex issues. The availability of staff resources and whether the agency has to contact the applicant for additional information will affect response time.
The exemptions and deferrals document states that the agency "will not routinely grant an exemption for products that claim to be too small to meet the requirements of the regulation. A number of design techniques are available to modify the packaging of products to meet the small package format under 21 CFR 201.66(d)(10) . . . The agency expects manufacturers to use alternative design techniques to increase available labeling space so that product labels are easier to read."
While the agency is "unlikely to grant exemptions based solely on the limits of existing packaging to accommodate the required content and format," it is more likely to allow firms to temporarily defer compliance with the regulation while the necessary packaging changes are made. Factors such as having to install new equipment or run new stability tests will be strongly considered. FDA generally will not grant exemptions from the 6-point type size requirement, but it may allow for deferrals.
The exemptions and deferrals process is considered to be a matter of public record. If a firm believes it will have to submit commercial or financial trade-secret information, it should contact the agency before submitting anything.
The finalized column-format guidance, which is effective immediately, can be seen at http://www.fda.gov/cder/guidance/3594fnl.htm. The exemptions and deferrals draft guidance can be seen at http://www.fda.gov/cder/guidance/3437dft.htm.
For further information on either document, contact Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), FDA, 5600 Fishers Ln., Rockville, MD 20857; phone 301/827-2222.
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