Document MJebnpd2xwrV2EeELm1LVpayV

RECEIVED OCT 6 1975 GEORGE GEORGE GEORGE LES Johnson Johnson a . | c. Drs. DRP 6. \ + - 5 WE --,, i Coronation NEW BRUNSWICK, N. J. 08903 September 29, 1975 Dr. Daniel Banes Director, Drug Standards Division U.S. Pharmacopeia 12601 Twinbrook Parkway Rockville, Md. 20852 Dear Dan, In reviewing the U.S. P. monograph requirements for Talc, we have noticed an apparent anomaly. Under " category ", talc is listed as a dusting powder and, as you may know, Johnson and Johnson uses talc as the base for several formulations that essentially are dusting powders. In the same monograph, under " advice ", is the notation: " Do not inhale. " I believe it is readily apparent that if talc, or a talc base product, is used for dusting purposes, an absolute prohibition against inhalation is impossible; some minimum level of inhalation will occur. Accordingly, we wish to request a review of this section of the monograph, with the objective of modifying the " advice " phraseology to a more correct and meaningful wording such as avoid " excessive inhalation. " or simply " Avoid inhalation during use. " Thank you for your attention to this request. ." Sincerely, rss | bcc: Mr. G. Lee * Dr. B. Semple G. E. Heinze, Director Science Information Protected Document -- Subject to Protective Order JNJ 000253050