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This legislation firmly states that virtually all medicines administered by injection are automatically designated as Prescription-Only Medicines (POM), creating a powerful legal hurdle that cannot be overcome by simply demonstrating safety through clinical trials alone

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Federal Prosecution and the Section 503A/503B Compounding Framework Compounding pharmacies provide a vital service by preparing customized medications, but their ability to work with raw active pharmaceutical ingredients (APIs) is heavily restricted by federal statute

doi: 10.1186/s13167-016-0051-9 34

Any bodily introduction into humans or animals is strictly prohibited