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OTC Small Package Exemptions To Be Handled Via Monograph Process - FDA

This article was originally published in The Rose Sheet

Executive Summary

Cosmetic-drug small package exemptions from the OTC labeling final rule should be addressed through the monograph process, FDA tells the Cosmetic, Toiletry and Fragrance Association in a Feb. 4 letter.

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OTC Labeling Reg Deferral For Convenience Size OTCs To Be Issued By FDA

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, the agency says in a recent letter to Lil' Drug Store Products

OTC Labeling Reg Deferral For Convenience Size OTCs To Be Issued By FDA

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, the agency says in a recent letter to Lil' Drug Store Products

OTC drug review

Skin protectant final monograph expected to be released early 2001 followed by opportunity for specific comment on reduced package labels, CFSAN OTC Drugs Director Charles Ganley, PhD, reports. CTFA requested cosmetic drug small package exemptions be addressed through the monograph process (1"The Rose Sheet" Feb. 14, p. 4)

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