IPSIS Joins AMA in Voicing Concerns About Potential FDA Compounding Guidance

News & Press: Advocacy

Wednesday, August 21, 2019

On August 13, 2019, IPSIS 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. IPSIS has previously addressedthis 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.

« Back to Index

	Edit This Favorite
Name:
Category:
Share:	Yes No, Keep Private

Edit This Favorite

IPSIS Joins AMA in Voicing Concerns About Potential FDA Compounding Guidance

Contact Us