Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers. We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well. Most of us think of CRCs as the bottle cap and the click-off tops when thoughts of a CRC dance in our heads.
Today, the FDA issued a guidance document entitled Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products and, wow, that hit me like a ton of bricks. Why did I never contemplate adding such a device to prescription or OTC oral liquid products? The guidance notes that most oral-liquid poisonings occur in children six years old and under, and further states that it takes a child aged three to four years about two minutes to empty a standard oral liquid container; however, a bottle with a flow restrictor can take the same child about six minute to empty it. Those extra four minutes could make the difference between life and death, based on the toxicity of the product. The guidance goes on to state, “In general, the incorporation of a flow restrictor reduces the total volume of liquid children are able to extract from liquid medicine bottles, which may reduce the risk of harm resulting from unintentional ingestions.”
In discussing flow-restrictor devices, the guidance identified two general types – closed-flow restrictors that limit access to a single dose at a time and close after that dose is administered, and open-flow restrictors that slow down the flow, allowing only for a continuous, controlled volume. In addition, the document discuses general recommendations and human-factor considerations. The full guidance can be found here.