Hi Terry Van Liew,
Yes, FDA is concerned about drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA).
Here are some details -
Reports, including some dating back several decades, describe a moldy or musty odor in food (and wine) products due to contamination with trace amounts of halogenated anisole compounds such as 2,4,6-tribromoanisole (TBA). An odor attributable to the presence of a halogenated anisole compound can be detected by consumers even when the offending compound is present at parts per billion or lesser levels. An upward trend in consumer complaints about musty or moldy odor led a drug firm to identify TBA as the odor-causing compound. The firm's investigation of this incident led to the detection of TBA in several oral products. The firm traced all of the contamination back to the use of certain wooden pallets used to transport drug packaging materials. TBA is prone to volatilize and adsorb onto articles stored near the TBA source. Because of their volatility, it appears that even minute levels of halogenated anisole compounds can adversely affect a large quantity of product in a single contamination incident.
You will find the information here https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-requirements-buildings-and-facilities ------------------------------
SUMATHA KONDABOLU
Senior Quality Specialist
Laval QC
Canada
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Original Message:
Sent: 16-May-2023 14:56
From: Terry Van Liew
Subject: Question on palette treatment
Hello,
Can someone advise if it is illegal to use 2,4,6 - tribromoanisole (TBA), 2,4,6 tribromophenol (TBP) and halogenated phenolic preservatives in coating palettes in the US? Are there any restrictions preventing use on palettes used for otc drugs?
Thank you,
Terry Van Liew
Sent from my iPhone