Originally Published PMPN February 2005
Regulatory Focus
Drug Facts Labeling Questions Answered
FDA releases guidance for those grappling with labeling revisions.
With the final deadline approaching for meeting OTC Drug Facts labeling rules, FDA is working to answer some of industry’s questions. In January 2005, the agency published a new guidance for industry, titled “Labeling OTC Human Drug Products, Questions and Answers.” Listing 35 questions and answers intended to help firms comply with the final rule, 21 CFR 201.66, the guidance is one in a series.OTC drugs approved or subject to a monograph finalized before May 16, 1999, had to comply with the rule by May 16, 2002. Drugs whose monographs were not finalized by May 16, 2002, have to comply by the date of the product’s first major labeling revision or by May 16, 2005, whichever comes first.
Since the final rule is made up of two main sections, one on content requirements and another on format requirements, the guidance is also broken into two parts, along with an appendix with several tables. The document explains how OTC drug monograph labeling information is converted to the OTC Drug Facts format.
For instance, the first question and answer detail the information that all drugs must bear on their label, under the following heading and in this order:
1. Drug Facts or Drug Facts
(continued).
2. Active Ingredients.
3. Purpose.
4. Use(s).
5. Warnings.
6. Directions.
7. Other information.
8. Inactive ingredients.
9. Questions? or Questions or
comments? (optional).
Question and Answer 6 explains how to convert a lengthy warning into a bulleted-text format. For instance, the warning for oral and topical antitussives states: “Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.” FDA says this warning can be converted into bulleted statements under the Warnings subheading “Ask a doctor before use if you have” as follows:
• cough that occurs with too much phlegm (mucus).
• chronic cough that lasts, as occurs with smoking, asthma, chronic bronchitis, or emphysema.
As this example demonstrates, the agency suggests the frequent use of bullets, and it recommends against the use of bold type.
Whether or not to use tables is also discussed. For instance, according to Question and Answer 13, information under the Directions heading does not need to be in a table format. The agency, however, notes that a table may present directions in a clearer format, especially if different age groups are involved.
To help OTC drug packagers keep track of all applicable labeling rules, not just the Drug Facts rules, FDA lists under Question and Answer 33 additional labeling requirements. One of those requirements, the rule on tamper-evident features statements, is addressed elsewhere, in Question and Answer 15. According to the guidance, a statement calling attention to tamper-evident features must be placed prominently on the package, but it does not need to be placed in the Drug Facts section. However, if firms choose to place it in this section, it must appear under the heading, “Other information.” The agency also notes that many products are now marketed with peel-back or fold-out labels. However, the tamper-evident features statement should not be included in this part of the label if the statement is only clearly visible by peeling back or folding out the label.
Marc Oosterlinck, general manager of CCL Label Inc. (Upland, CA), reports that his firm has been producing expanded-content labels for companies working to meet the Drug Facts rule. “In most cases, people have to use a different label, because their packages aren’t big enough,” he says, “unless they are using a carton.” Even then, though, a label may be needed, since the label remains with the product throughout use, he says. Oosterlinck also reports that his firm is working with a customer “that used the inside of its product carton for Drug Facts labeling, and FDA told them that that wasn’t acceptable.”
For the complete guidance, visit http://www.fda.gov/ohrms/dockets/98 /2004D-0549-GDL0001.doc.
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