News & Press: Advocacy

SIS Joins AMA in Voicing Concerns About Potential FDA Compounding Guidance

Wednesday, August 21, 2019  
On August 13, 2019, SIS joined the AMA and 20 other medical specialty societies in submitting a comment letter to the Food and Drug Administration (FDA) to voice concerns about potential FDA guidance that could restrict physicians’ ability to prepare sterile drug products for administration to their patients in the office setting. SIS has previously addressed this issue with the FDA in a comment letter dated July 15, 2016 explaining that drawing aliquots of two sterile medications from single-dose vials into a single sterile syringe for immediate administration to a specific patient does not constitute compounding, but rather falls under the umbrella of administration of sterile medication. For many medical specialties, in-office preparation and administration of these products represents the long-held standard of care and generally presents an extremely low risk to patient safety.

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