OTC Labeling Rule General Deferral For Convenience-Size Drugs To Be Issued
This article was originally published in The Tan Sheet
FDA will publish a notice to "delay the compliance date of the current Drug Facts rules with respect to 'convenience-size' drug packages" in an upcoming issue of the Federal Register
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Pfizer asks FDA for seven-month extension of May 16 "Drug Facts" labeling compliance deadline for convenience roll packages of regular, extra strength Rolaids. Additional time is necessary "to ensure...we can acquire, install and validate the equipment that is necessary to produce, on a reliable, repetitive basis, a 'compliant' roll package," Feb. 27 submission states. Pfizer cites Lil' Drug Store Products' petition for an industry-wide labeling deferral for convenience-size packages; FDA responded to the petition in January, saying a notice delaying the compliance date for such packages would be published in an upcoming Federal Register notice (1"The Tan Sheet" Feb. 4, 2002, p. 5)...