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the drug is subject to an open drug efficacy study, health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition, and there is insufficient supply of an FDA-approved drug

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Even "clean-looking" surfaces harbor microorganisms

Storer et al., 2013)

Liposomes that are stable for an extended period of up to two years in a liquid state

Testing has found significant contamination rates in some peptide products, including incorrect amino acid sequences, endotoxin contamination, and mislabeling