FDA Requirements For Child-Resistant Packaging

Child-Resistant Packaging (CRP) is an important safety measure designed to protect children from accessing potentially dangerous items. CRP has been developed to reduce the risk of unintentional ingestion, inhalation, and contact with hazardous products by making it difficult for a child to open or gain access to them. CRP involves a range of design features that make it difficult for a child to open or access the contents within, while still enabling adults to do so with ease.

The Food and Drug Administration (FDA) works to protect public health by ensuring that drugs, medical devices, and other consumer products are safe for use. One important way the FDA does this is by requiring child resistant packaging on certain products. Child-resistant packaging is designed to prevent young children from accidentally accessing hazardous substances. In order to ensure a product meets the safety standards set by the FDA, manufacturers must follow certain requirements for child-resistant packaging.

Is It Child-Resistant Packaging Necessary?

When it comes to keeping children away from hazardous items, child-resistant packaging is an important tool. But is it necessary? It depends on the situation and what kinds of risks are present. 

For parents and those responsible for taking care of young children, child-resistant packaging can be an essential safeguard against accidental ingestion or contact with potentially unsafe items like medicine or cleaning products. It can also provide peace of mind that young ones won’t gain access to something they’re not supposed to have. 

On the other hand, there are situations where child-resistant packaging may not be necessary. For example, if none of the items stored in a household pose any risk to young kids, then child-resistant packaging may not be needed.

Regulations for Manufacturers Of Child-Resistant Packaging

Regulations for Manufacturers Of Child-Resistant Packaging

The U.S. Food and Drug Administration (FDA) has released regulations for manufacturers of child-resistant packaging, which are used to reduce the risk of accidental poisoning among children. Under these regulations, all pharmaceutical drug products in solid or liquid dosage form must be placed in child-resistant packaging that meets certain standards established by the FDA. 

Manufacturers must ensure that their child-resistant packaging is effective at preventing access by children under five years old while still being easy enough to open for adults who don’t have any physical impairments. Additionally, they must provide appropriate directions for how to operate and reclose the package securely after use. The packaging also needs to be constructed from materials that are strong enough to prevent leakage during transport and storage but not so hard as to make it difficult for adults with disabilities such as arthritis or vision impairment to open them without assistance.

Labeling Requirements From FDA:

Labeling Requirements From FDA


The U.S. Food and Drug Administration (FDA) has specific labeling requirements for child-resistant packaging that manufacturers must adhere to in order to ensure the safety of consumers, particularly children. This includes providing warning labels and symbols on packages indicating the potential hazard of consuming a product as well as instructions on how to properly open and close the container.

These labeling requirements are designed to make it difficult for children under 5 years old to access dangerous products, such as medications, cleaning supplies, and automotive fluids. The FDA requires that such labels include standard pictograms or text warnings with specific phrasing in both English and Spanish so that language is not a barrier when ensuring safety. Additionally, these labels must be easily readable by adults and prominently displayed on the package itself so they can be seen clearly when picking up or examining products before purchase.

Testing & Certification Procedures:

FDA is responsible for developing regulations to ensure the safety of products intended for use by children, including those that come in child-resistant packaging. As part of this responsibility, the FDA has developed stringent testing and certification procedures for these containers to ensure they cannot be easily opened by children under 5 years old. 

The certification process begins with container manufacturers submitting their products to an accredited laboratory approved by the FDA for testing. The containers are then tested according to standards issued by the American Society for Testing and Materials (ASTM). If a container meets all requirements, it will receive a Child-Resistant Certification from the FDA, which must be renewed every three years. 

Once certified, manufacturers must ensure that only containers meeting the standards are sold or distributed in commerce within the United States.

Exemptions to CRP:

When the U.S. Food and Drug Administration (FDA) introduced Child-Resistant Packaging (CRP) in 1970, they had one goal: to reduce the number of injury and death cases as a result of children ingesting hazardous substances. Despite this life-saving measure, there are several exemptions when CRP is not required on products that can be dangerous if ingested by children under 5 years old. 

The FDA does not require CRP for certain products, such as those labeled for adult use only or those that have an ingredient with a low potential for causing adverse health effects. Additionally, prescription drug packages are exempt from the CRP rule if they contain no more than two dosage units per package and their purpose is unit dose administration and/or convenience packaging.

What parent should look for in Child-Resistant Packaging?

What parent should look for in Child-Resistant Packaging?

As a parent, it is important to take extra precautions when it comes to the safety of your children. One of the things that can help ensure their safety is investing in child-resistant packaging for hazardous materials and products. Child-resistant packaging is specifically designed to protect young kids from accessing potential toxins or choking hazards.

When looking into child-resistant packaging, there are several key points you should consider. Firstly, it’s important to look for a product that has been tested according to industry standards and qualified by a third-party testing lab as child-proof. Secondly, you should check if the manufacturer has used an appropriate closure system such as a tamper-evident band or twist cap with an audible click mechanism so you know when it’s securely closed.


It is essential for manufacturers to understand the FDA’s requirements for child-resistant packaging. With this knowledge, manufacturers are better equipped to keep children safe from potentially hazardous products. Knowing the regulations regarding child-resistant packaging also helps prevent companies from facing potential legal ramifications due to inadequate packaging and labeling. In order to ensure that children remain safe, it is important for manufacturers to not only adhere to the guidelines set forth by the FDA but also regularly review their packaging practices

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