FDA presents a Q&A on the current TBA/Wooden Pallet issue that has resulted in several drug recalls

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“The source of TBA-contaminated drug products appears to have been 2,4,6-tribromophenol (TBP), a chemical used as a wood preservative. Certain fungi are able to survive in TBP-treated wood by converting TBP to its anisole analog, TBA[1]. In the recent contamination incident, an investigation found that TBP-treated wood was used to manufacture pallets that were then used to ship and store drug packaging material. Currently, the use of halogenated phenolic compounds to preserve wood appears to be very rare as this practice is either discouraged or prohibited in many regions of the world, including the US. However, TBP treatment of wood continues in some regions that supply wood to the US and other countries.”

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Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Buildings and FacilitiesQuestions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Buildings and Facilities