USA – FDA Drafts Guidance on Restricted Delivery Systems for Liquid Drugs

In an effort to reduce the incidence of accidental drug ingestion by children, the US Food and Drug Administration (FDA) on Tuesday issued draft guidance detailing considerations for when drugmakers should employ restricted delivery systems for oral liquid drugs.

Despite advancements in other forms of child-resistant packaging, such as blister packaging and safety caps, FDA says that accidental ingestion of oral liquid drugs accounts for nearly 10,000 emergency department visits annually by children under six.

Specifically, the 10-page draft guidance provides recommendations for when restricted delivery systems should be considered, as well as human factors and design considerations and directions for use for products that feature restricted delivery systems. The guidance also describes two types of flow restrictors that could be used based on product characteristics, closed flow and open flow restrictors…