FDA Responds to SPAARx, Agrees to Delete "Specialty Pharmacy" from Compounding Legislation


The FDA indicated in a letter to SPAARx that future compounding legislation will omit the term "specialty pharmacy."

The FDA indicated in a letter to SPAARx that future compounding legislation will omit the term “specialty pharmacy.”

In an effort to protect the interests of the specialty pharmacy industry, SPAARx reached out to the FDA in April and asked the agency to reconsider the use of the term “specialty pharmacy” interchangeably with the term “compounding” in future legislation.

According to an email from SPAARx, the FDA responded to the request this week. Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, thanked SPAARx for bringing the issue to the FDA’s attention and noted that the agency is now actively involved with drafting the new legislation.

According to SPAARx, Dr. Woodcock wrote in a letter to SPAARx interim director Bill Sullivan that “drafts of this legislation now correctly define the issue" and apparently have deleted the specific use of the term 'specialty pharmacy.'

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