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FDA Releases New Guidance for Child Resistant Packaging


Accidental exposure to medicine by children under the age of six results in over 500,000 calls to the poison control center and more than 60,000 emergency room visits annually in the United States. This comes at a time when Americans are using more medicines than ever, especially when factoring the increase of three-generation households or grandparents caring for children, which results in increased opportunities for accidental exposure to medicines. In addition, an aging population increases the amount of people who suffer with grip strength, arthritis, vision and motor skill issues that can often times make opening drug packaging difficult or impossible.

On August 2nd, 2017, the Regulatory Affairs Professionals Society (RAPS) reported that the Food and Drug Administration (FDA) “published draft guidance to help ensure child-resistant packaging statements in drug labels [are] clear, useful, informative and, to the extent possible, consistent in content and format.”

The FDA’s “Child-Resistant Packaging Statements in Drug Product Labeling—Guidance for Industry,” refers to the 1970 Poison Prevention Packaging Act enacted to protect children. This recently released guidance covers household products, including oral prescription and nonprescription drugs. The guidance also reports on drug storage, labeling, and the process for including statements on Child Resistant Packaging labeling.

Child Resistant Packaging will always be a critical issue. Additional guidance and recent Child Resistant Packaging examples follow:

Contact Quality Packaging Specialists International with any questions or to learn more about Child Resistant Packaging.


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