April 26, 2024

Mass confusion: Our letter

This week, APC submitted a comment letter to the Massachusetts Board of Pharmacy about two issues on which the Board recently expressed concern. As our Board chair reported last week, the Massachusetts Board had indicated that compounding sublingual semaglutide violated FDA’s “essentially a copy” guidance. In our letter, we enunciated the statutory basis that clearly allows sublingual forms of semaglutide to be compounded.

Our letter also discusses the Massachusetts Board’s statements prohibiting Massachusetts-based 503B outsourcing facilities distributing compounded medications to resident 503A pharmacies for dispensing.