Congressman José E. Serrano

Representing the 15th District of New York

Congressman Serrano Introduces Bill to Require that Over-the-Counter Medicines are Packaged with Dosage Devices

Mar 16, 2017
Press Release

Washington, DC – Congressman José E. Serrano today introduced the Protecting Our Kids Act of 2017, which would direct the Food and Drug Administration to require pharmaceutical companies to include dosage delivery devices, commonly known as flow restrictors, when selling over-the-counter medicines.

“More than 70,000 children end up in the emergency room (ER) every year as a result of an unintentional medication overdose. These accidents are easily avoidable. By simply requiring pharmaceutical companies to include flow restrictors with over-the-counter medicines, the Protecting Our Kids Act of 2017 will help prevent tens of thousands of accidents every year. It will also make the lives of children and parents easier when taking or dispensing medicine to treat an illness or condition.  This legislation will help keep our children safe by ensuring they receive the appropriate dose of medicine while at the same time reducing our healthcare costs,” said Congressman Serrano.

Flow restrictors are used voluntarily in the drug industry in infants’ and children’s acetaminophen products.  A syringe is inserted into a small opening (a self-sealing cap) and the exact amount of medicine required is withdrawn, rather than relying on a cup or spoon that could lead to error.  The device also slows the flow of medicine, making it more difficult for a child to ingest a dangerous amount.  The FDA has indicated its support of flow restrictors, but they have not been required by law.