Skip to content

Child-Resistant Packaging

Child-Resistant Packaging

Prescriptions and over-the-counter medicines can save lives and help manage certain conditions when used correctly. However, when medicines are taken in error, unfortunate reactions and injury can follow. The American Academy of Pediatrics and the Healthy Children Organization report that more than 7,000 children visit hospital emergency rooms every year for problems related to medication errors. Child-resistant packaging, also known as “special packaging,” is used to reduce the risk of poisoning in children through the ingestion of potentially hazardous medications such as prescription and over-the-counter medications, pesticides and household chemicals.

According to the Poison Prevention Packaging Act, “The term ‘‘special packaging’’ means packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.”

Children’s Medicine Label Requirements

According to the US Consumer Product Safety Commission, children’s products that are designed or intended primarily for use by children ages 12 or younger must have distinguishing permanent marks (generally referred to as “tracking labels”) that are affixed to the product and its packaging and provide certain identifying information. All tracking label information should be visible and legible.

Child Resistant Packaging Requirements

As pharmaceutical packaging continues to advance, national and international regulators are stressing child resistance packaging compliancy. Pharmaceutical companies must abide by these strict regulations regarding child resistance packaging and abide by the requirements set up by the US FDA.

Child-resistant closures required for nasal products containing imidazolines

The Consumer Product Safety Commission (CPSC) is issuing a rule to require child-resistant (CR) packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline, a class of drugs that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, in a single package. Imidazolines are a family of drugs that are vasoconstrictors indicated for nasal congestion and/or ophthalmic irritation. Products containing imidazolines can cause serious adverse reactions, such as central nervous system (CNS) depression, decreased heart rate, and depressed ventilation in children who accidentally ingest them. Based on the scientific data, the Commission has determined that availability of 0.08 milligrams or more of an imidazoline in a single package, by reason of its packaging, is such that special packaging is required to protect children under 5 years old from serious personal injury or illness due to handling or ingesting such a substance. The Commission takes this action under the Poison Prevention Packaging Act of 1970 (PPPA) and voted to publish this notice in the Federal Register.

The rules that detail out what a child-resistant package is and what products require such packaging are published in the Code of Federal Regulations in Title 16, Part 1700. Because the Commission may update rules from time to time, it is advised to check periodically for new or revised rules in the Code of Federal Regulations.

As regulations are continuously being updated, consumers may not know why they are seeing changes with their products, but you can use this as an opportunity to help them understand the value with new packaging. Hughes Enterprises can help you determine which products work reliably and protect your bottom line. For help with ordering your packaging labels for your shipping and packaging operation contact a Hughes Sales Representative for assistance.