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However, severe persistent vomiting (more than 3 episodes per day for more than 2 days), signs of pancreatitis (severe abdominal pain radiating to the back), or allergic reactions (hives, difficulty breathing, facial swelling) warrant immediate protocol cessation and medical attention

FDA will consider the Committees guidance and, if it concludes a substance is appropriate, will initiate the rulemaking process required to formally add it to the 503A Bulks List

Alternate the injection sites, especially with subcutaneous injections, to avoid irritation