Document mq7BGybm4vw5r3yJErwnV8X7Z

FILE NAME Talc TALC DATE 2020 Aug 18 DOC TALC204 DOCUMENT DESCRIPTION Email to Barry Castleman from USP From NF Monographs nfmonographs@usp.org Date Tue Aug 18 2020 at 9:23 AM Subject Talc Asbestos History 30 Case Number 00061446 [ _00D4164Hr._5002M19bGfv _00D4164Hr._5002M19bGfv ] To barry.castleman@gmail.com barry.castleman@gmail.com Mr. Castleman Thank you for your question Your email was forwarded to me at the NF monographs account to answer queries relating to the USP Excipient monographs and general chapters As you may already be aware this USP monograph is part of the Pharmacopeial Discussion Group PDG The PDG EP JP and USP works to harmonize excipient monographs and general chapters which will reduce manufacturers burden of performing analytical procedures in different ways using different acceptance criteria Here is what I can tell you about the Talc monograph and its history According to the historical file it indicates Talc was first introduced into the USP in 1900 in USP VIII 8 In PF 28 May 2002 there was a proposal to add the labeling statement and tests in the monograph for the absence of asbestos The monograph was then proposed in 29 Feb 2003 with the same labeling statement and tests for the absence of asbestos A Stage 6 this indicates harmonization with the EP and JP was posted in PF 30 Sep 2004 official and the following were added 1. Labeling - A requirement that the labeling indicate its suitability for oral or topical administration is added A requirement that the labeling indicate the absence of asbestos is also added 2. Absence of asbestos - This section is added to ensure that the article does not contain asbestos Talc derived from deposits that are known to contain associated asbestos is not suitable for pharmaceutical use The monograph was then published in the 2nd Supplement of USP NF 23 which was Aug 1 2005 as part of the harmonization process Please keep in mind it became official Sep 2004 as part of the Stage 6 publication Now what is considered the official version is in USP42 on page 4165. Since 2004 the information stated above regarding the absence of asbestos has not changed Please be aware just because this information was added to the monograph in 2004 does not mean mining companies who handle Talc were not already testing for it For background information USP currently has an Expert Panel who are working on the Talc monograph and this expert panel is made up of the FDA industry experts and manufacturers of talc and they have been working to improve the monograph to reflect what is needed to make sure asbestos is not present as well as improve the overall monograph to reflect the testing needed for its use in pharmaceutical product Once they get a draft it will be published in the Pharmacopeial Forum PF Please go to http://www.usp.org/USPNF/pf/ to register for free The PF gives access to new proposed monographs and general chapters along with proposed changes to all current monographs and chapters in the USP with background info for these changes Additionally please go to https://www.usp.org/frequently-asked-questions/talc-monograph to see the FAQ's which should give you more information including links to stimuli articles and where the Talc panel is in their process Another link is https://www.uspnf.com/notices/talc20200731 This is a notice for the intent to rvise the monograph based on the expert panel and is mentioned in the FAQ's Finally as a scientist I believe stating Talc is asbestos free could be misleading One needs to know the limit of quantitation limit of detection for the assay being utilized which is why this expert panel has been working on the monograph as stated in the notice Please let me know if you have any further questions You are also encouraged to follow the link in my signature below to take an anonymous survey Thank you Robert Lafaver Technical Service Manager Global Commercial Ops 12601 Twinbrook Parkway Rockville Maryland 20852 United States 301-816-8335 Phone nfmonographs@usp.org usp.org This response has been provided for informational purposes only and should not be construed as an official interpretation of USP text or relied on to demonstrate compliance with USP standards or requirements Please do not remove this ref Id _00D4164Hr._5002M19bGfv _00D4164Hr._5002M19bGfv wana nn nana anne Original Message --------------From Barry Castleman barry.castleman@gmail.com Sent 8/14/2020 9:30 PM To rstech@usp.org Subject Asbestos Contamination in Talc Dear Sir or Madam From what I can tell USP talc did not include any reference to asbestos until 2008. Can you confirm this or correct me There is concern about asbestos in talcum powders all over the world and some manufacturers claims that they used USP talc or pharmaceutical grade talc seem unmoored to any specifications that support the derivative assertion that this meant the USP talc was asbestos before 2008 Thanks for your trouble in answering my inquiry Barry Barry Castleman ScD