The FDA is warning against the compounding of remdesivir, a treatment for COVID-19, due to the active pharmaceutical ingredient’s risks by 503A facilities. While the drug, under the brand name Veklury, is approved for use, the FDA encourages compounders to avoid it as the API is complex and does not have a USP monograph or another public quality standard available. According to the FDA, the API has multiple polymorphic forms that affect the compounded drug’s quality and solubility. Additionally, the drug does not qualify for exemptions under 503B as it has not been added to the bulk list, nor does it appear on the drug shortage list. NCPA will continue to monitor the FDA’s activity on this matter should the situation and the need for the drug change.
NCPA
