McNeil “Drug Facts” Booklet Pouch Labeling Proposed For Two-Count Sizes
This article was originally published in The Tan Sheet
Executive Summary
McNeil Consumer Healthcare is requesting a six-month deferral from the OTC labeling final rule requirements to implement "booklet pouch" labeling for two-count sizes of five products
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McNeil Consumer Healthcare is requesting a six-month deferral from the OTC labeling final rule requirements to implement "booklet pouch" labeling for two-count sizes of five products. In similarly worded deferral requests filed with FDA Nov. 27, McNeil says it has developed a "booklet style pouch to accommodate implementation" of "Drug Facts" labeling on packets of Motrin IB Caplets, Tylenol Sinus Geltabs, Tylenol PM Gelcaps, Tylenol Sinus Caplets and Imodium AD Caplets. The products at issue are sold in two-count pouches made of polyethylene, polyester, foil and/or paper. Each pouch has a "limited amount of space available for labeling," McNeil notes. The company says the "pages" of its proposed "booklet pouch can be opened by the consumer, thus providing complete labeling information." Each "booklet format" package measures 2-1/2 inches by 2-3/8 inches and consists of four pages, with pages one and three constituting the booklet's outside pages and pages two and four making up the inside pages. Page one serves as the front of the package, with the product name, trade dress and beginning of the "Drug Facts" box. Below the box on the first page are arrows and the statement: "Open here to view complete product information." The "Drug Facts" box continues on each page, ending on page four. Page three, which serves as the back of the package, includes a pictogram of scissors and directions for opening the pouch to access the pills inside. "Actual use of this booklet pouch may require additional compliance time for implementation," necessitating an extension of the May 16, 2002 OTC labeling deadline "to ensure that we can acquire, install and validate the equipment that is necessary to produce, on a reliable basis, a 'compliant' booklet pouch package," McNeil tells the agency. The company points out the pouch "is an innovative packaging technology and requires sufficient development time to master the interface between equipment and material." Under the J&J division's timeline for implementing the booklet pouch, McNeil would order and obtain the appropriate equipment in the first quarter of 2002. Equipment installation and validation, finalizing booklet pouch specifications and line testing and resolution of potential material issues would occur in Q2. Packaging validation and initiation of production would occur in the third quarter, with shipments beginning in the fourth quarter of 2002. In March 2000, FDA granted McNeil's sister company, J&J/Merck, a nine-month deferral from compliance with the OTC labeling format for sample pouches of the H2 antagonist Pepcid AC so the company could acquire, implement and validate the equipment necessary to produce compliant sample pouches (1 (Also see "Pepcid AC Gelcaps Sample Pouch Deferral Granted Without "Drug Facts" Title" - Pink Sheet, 1 May, 2000.), p. 4). J&J/Merck doubled the size of the pouches. In a draft guidance published in December 2000, the agency said it would consider deferral requests to allow manufacturers to shift to alternative package styles, and requested that companies provide a projected timetable for completion of the new labeling or packaging process (2 (Also see "OTC Labeling Exemption, Deferral Timelines Depend On Complexity - FDA" - Pink Sheet, 1 Jan, 2001.), p. 10). McNeil submitted deferral requests for 10-count convenience size vials of Tylenol Extra Strength and Tylenol PM in July (3 (Also see "Labeling exemptions" - Pink Sheet, 6 Aug, 2001.), In Brief). Novex Pharma also recently requested labeling deferrals for its 2% minoxidil (Pharmacia's Rogaine Regular Strength for Men, Rogaine for Women) and 5% minoxidil (Rogaine Extra Strength for Men) topical solutions because "there is not currently approved reference listed drug labeling in Drug Facts format (DFL)" or a final Office of General Drugs DFL template for the hair loss prevention treatments. Although FDA has issued a template for 2% minoxidil, Novex said it is unclear whether it constitutes the final template. In a Sept. 19 submission to FDA, Perrigo said the agency was expected to change the template (4 (Also see "FDA "Drug Facts" Templates Supersede Reference Listed Drug Labeling - FDA" - Pink Sheet, 1 Oct, 2001.), p. 3). Novex' ANDA (75-839) for 5% minoxidil was approved Oct. 1. However, the company is not currently marketing the product. No template has been issued for 5% minoxidil. Similar to Perrigo's earlier submission, Novex also requests varying deferral dates for the minoxidil products based on the date a final template or approved reference listed drug labeling becomes available. |