US FDA's Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution

The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.

vialandmultiplesyringes_1200x675 — Community distribution programs like injectable naloxone, in part because it is the cheapest to purchase. • Source: Shutterstock

The US Food and Drug Administration is hoping a written statement, rather than a label change, will suffice as the necessary clarification that the injectable naloxone formulation is appropriate for community distribution.

Acting US Food and Drug Administration Commissioner Norman Sharpless addressed what he called "a persistent misunderstanding" that the label for...