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U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products; Draft Guidance for Industry

About this resource:

Non-Systematic Review

Source: Food and Drug Administration

Last Reviewed: March 2020

Workgroups: Medical Product Safety Workgroup

This Food and Drug Administration (FDA) draft guidance offers recommendations for drug manufacturers on the use of restricted delivery systems like flow restrictors. Along with other measures, like child-resistant packaging, flow restrictors can lower the risk of children unintentionally swallowing oral liquid drugs. Flow restrictors are attached to medicine bottles to either slow the flow of liquid from the bottle, or to prevent the flow of liquid without a special dosing device (for example, a syringe). 

FDA recommends that drug manufacturers consider the use of restricted delivery systems on liquid drugs and encourages manufacturers who want to develop restricted delivery systems to involve FDA early in the development process.

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Objectives related to this resource (1)

Reduce emergency department visits for medication overdoses in children under 5 years — MPS‑01
Little or no detectable change

Suggested Citation

1.

Food and Drug Administration. (2020). Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products; Draft Guidance for Industry. Retrieved from https://www.fda.gov/media/136170/download.