Certain medications, over-the-counter (OTC) and prescription, pose a danger to children if ingested, and are required to be contained in child-resistant packaging. Child-resistant packaging saves children’s lives, so it’s important to fully understand which medications should and should not be dispensed in child-resistant packaging. In this article, we will detail what you need to know about United States child-resistant packaging regulations for your pharmaceutical business.
What Are the Regulations for Dispensing Medications in Child-Resistant Packaging?
The 1972 Poison Prevention Packaging Act (PPPA) mandates that hazardous materials, or those that could become hazardous, be sold in special packaging. This law covers medications, household chemicals, and pesticides. The PPPA specifies that this special, child-resistant packaging should make it difficult for children to open the package or access the material inside. But what exactly is special packaging? The act specifically states:
The term “special packaging” refers to 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 it does not mean packaging that all such children cannot open or obtain a toxic or harmful amount within a reasonable time.”
Which Medications Need to Be Dispensed via Child-Resistant Packaging?
Many types of medication are required to be dispensed via child-resistant packaging. You can see the full list of regulated medications here. Below are some common medications that must be dispensed in child-resistant packaging:
- Acetaminophen
- Aspirin
- Dietary supplements
- Diphenhydramine
- Fluoride
- Ibuprofen
- Imidazolines
- Lidocaine
- Methyl salicylate
- Mouthwash
- Naproxen
- OTC switch medications
- Prescription medications
Which Medications Do Not Require Special Packaging?
The PPPA allows one single size package of regulated medications to be non-child-resistant due to concerns about senior adults and disabled individuals being able to easily access medications. This single size package is allowed as long as complying packages are also supplied, and so long as they are labeled with “for households without young children” or “package not child-resistant.”
While many medications require special packaging, some do not. Some exempt medications may include the following:
- Effervescent acetaminophen
- Effervescent aspirin
- Hormone replacement therapy drugs
- Oral contraceptives
- Powdered iron supplements
- Powdered unflavored aspirin
Do I Need to Ensure My Products Pass the Child-Resistant Packaging Test?
Yes. Pharmaceutical and other industries have a special responsibility to ensure their products do not pose a danger to children who may come across them. If your business produces OTC or prescription medications that contain any potentially hazardous materials, they will most likely need to be enclosed in child-resistant packaging.
Child-Resistant Packaging Testing
Child Related Research has tested the efficacy of child resistant and senior friendly packaging for more than 50 years, ensuring the safety of children worldwide.. Child Related Research is accredited to the US and international child safety standards . We have the tools and resources to test the safety and reliability of your product’s packaging, making sure they are safe for consumers to bring into their homes. If you would like to learn more about child-resistant package testing, contact Child Related Research today. or call us at 801-904-3893.
