On October 28, 2025, the Rhode Island Department of Health (“RIDOH”) issued a public notice of a proposed amendment to 216-RICR-40-15-1: “Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors” (the “Proposed Rule”). Among the notable changes, RIDOH updates its definition of “compounding.” Specifically, it adds to the definition that the “[a]ddition of vitamins, nutrients, and/or medications to intravenous fluid bags is compounding.”
Physician practices, IV therapy practices, wellness clinics, and any other practice that is offering IV vitamin, nutrient, or medications should take note of this update. As a result of its interpretation of USP 797 guidance and regulatory definitions, RIDOH had previously stated that the addition of vitamins, nutrients or other non-standard additives to a sterile bag constitute “compounding.” The Proposed Rule now codifies that prior interpretation.
If providers have comments on the Proposed Rule regarding the definition of compounding, the window to submit comments for RIDOH’s consideration is now open. The public may submit comments on or before November 27, 2025. After receipt and consideration of the comments, RIDOH will issue a final rule.
Bottom Line:
If you operate an IV therapy service, physician practice, or wellness clinic that adds vitamins or other substances to saline bags (or similar sterile infusions), this is a reminder to ensure that your practice complies with all rules, regulations, and guidance for sterile compounding in Rhode Island.
