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(3) Product furnished from a container with a total labeled volume 2 mL or less for which product labeling does not have language indicating the package type term, like single-dose container, single-use package, multiple-dose container, or single-patient-use container

Many of these agents are not approved by the FDA for musculoskeletal indications and may be compounded or sourced outside regulated pharmaceutical manufacturing pathways

Um sie dennoch zu vertreiben, nutzen Hndler oft eine juristische Grauzone: Sie deklarieren die Ampullen als "For Research Use Only" (Nur fr Forschungszwecke) oder "Not for Human Consumption"

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