Docket Management
Docket: 77N-094I - Internal Analgesic, Antipyretic, Antirheumatic Drug Prod. for OTC Human Use
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Suzanne Matuszewski Date/Time 2002-11-15 15:04:59
Organization BASF Corporation
Category Company

Comments for FDA General
1. General Comments Dockets Management Branch (HFA-305)Food and Drug Administration5630 Fishers Lane, Room 1061Rockville MD 20852RE: Docket 77N-0094Comment to the Proposed Amendment of the Tentative Final Monograph for Internal Analgesic, Anti-pyretic and Anti-rheimatic Drug Products for Over The Counter Use.Dear Sir/Madam:BASF Corporation, a major domestic producer of Ibuprofen active pharmaceutical ingredients, hereby requests the Food and Drug Administration (FDA) consider impurity characteristics (namely lead) of ibuprofen 200 mg tablets for Over The Counter (OTC) human use. In doing so, we ask that you extend the comment period to the proposed amendment by 90-days in order to allow more analysis to be completed.BASF Corporation became recently aware of the presence of elevated levels of lead in non-domestic sources of bulk ibuprofen. BASF Corporation’s preliminary testing of foreign sources of ibuprofen has shown levels of lead higher than expected and also higher than in other manufacturers’ domestic sources. Lead exposure has been reduced over the years by FDA through regulatory programs limiting the levels of lead allowed to reach the general public. BASF Corporation believes that the Tentative Final Monograph (TFM) for Internal Analgesic, Anti-pyretic and Anti-rheumatic Drug Products should be amended to include a consideration of limiting the amount of lead allowed in Ibuprofen 200 mg tablets. Our internal testing confirms these levels in various foreign sources. By allowing an extension to the comment period, FDA will allow time for analysis to be completed so that a safety factor considering lead could be included in the TFM.If you have any questions, please feel free to contact me at 973.426.4451.Regards,Suzanne A. MatuszewskiManager, Regulatory Affairs and Product Stewardship

EC -1