Comment from OUTSOURCING FACILITIES ASSOCIATION

Summary: The Outsourcing Facilities Association (OFA) argues that phenylephrine hydrochloride should be included on the 503B Bulks List because there is a significant clinical need for various concentrations and dosage forms that are not met by commercially available products. They contend that the current commercial product (BIORPHEN) is unsuitable for many indications and that removing the bulk substance from the list would create drug shortages and compromise patient safety.