FDA requirements for child-resistant packaging

In their draft Guidance for Industry "Child-Resistant Packaging Statements in Drug Product Labeling" the FDA has defined how medicinal products need to be labelled in the USA if their packaging is child-resistant. It is aimed at applicants, manufacturers, packing operations and wholesalers.

The "Poison Prevention Packaging Act (PPPA)" was implemented in the USA in 1970 in order to protect children under the age of five from unintended intake of substances in the household. This includes food products, cosmetics and pharmaceuticals. Until 1973, the FDA had been responsible for the enforcement of this law and after that, the "U.S. Consumer Products Safety Commission (CPSC)".

There are different approaches to making packaging materials child-resistant, e.g. by utilisation of a child-resistant closure such as a safety cap or by using certain single-dose blister packaging like peel-push blisters.

Child-resistant packaging is regarded as an important public safety measure through which the harmful and unintended intake of medicinal products by children is to be prevented.

When processing authorisation applications, the FDA evaluates various details about the containers and closures. This includes the type of packaging material which is to be used, the product's stability inside this packaging material and whether the closure design is suitable for the product. However, die FDA's assessment does not include the testing and assessment for whether or not a product complies with the provisions of the "Poison Prevention Packaging Act (PPPA)".

Since persons involved in health care and patients cannot see directly whether packaging is child-resistant or not, this information is supposed to be added to the labels in the future. The guideline therefore includes specific examples for the correct labelling of prescription and non-prescription drugs.

For more details please see the draft FDA Guidance for Industry "Child-Resistant Packaging Statements in Drug Product Labeling".

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.