American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the biopharmaceutical protein production process; scientific facts for use in the policy discussion about biosimilars; the European Union system for biosimilars; and the current status of biosimilars legislation in the United States are described. ⋯ The legal and regulatory status of biosimilars remains to be resolved in the United States as policymakers address the scientific and policy issues surrounding product manufacturing, patent terms, and clinical use.
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Am J Health Syst Pharm · Jul 2008
A collaborative effort to comply with USP chapter 797 for compounding sterile preparations for investigational use.
A collaborative effort between two pharmacy specialty areas for ensuring compliance with United States Pharmacopeia (USP) chapter 797 for compounded sterile preparations (CSPs) is described. ⋯ A collaborative effort between two specialty areas of pharmacy services ensured compliance with USP chapter 797 requirements for compounded sterile preparations.