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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Review

Standards of Child Resistant Packaging: A Regulatory View

Gowthami Kodlahalli Ravindra1, Bhoopathi Subramaniam1, Balamuralidhara Veeranna2★★ Corresponding author

  1. 1Department of Pharmaceutics, Regulatory Affairs Group, JSS College of Pharmacy, Mysore, Karnataka, INDIA.
  2. 2Department of Pharmaceutics, JSS College of Pharmacy, Mysore, Karnataka, INDIA.

CORRESPONDENCE

Balamuralidhara Veeranna

Dr. Balamuralidhara. V Associate Professor & HOD, Department of Pharmaceutics, JSS College of Pharmacy, Mysore-570015, Karnataka, INDIA.

baligowda@jssuni.edu.in

Received: 21-04-2023; Revised: 28-07-2023; Accepted: 22-08-2024.

Volume 58, Issue 4 · pp. 1045–1053 · PUBLISHED Oct-Dec 2024 · DOI: 10.5530/ijper.58.4.116

View on IJPER original site ↗

ABSTRACT

Aim Special packaging known as “child-resistant packaging” is intended to minimize the possibility of kids eating harmful substances. The Poison Prevention Packaging Act of 1970 confers jurisdiction to regulate this on the U.S. Consumer Product Safety Commission and amended in 1995 to include senior-friendly packaging which became effective in 1972. Materials and Methods For the protection of children, regulations apply to prescription pharmaceuticals, over-the-counter medicines, insecticides, home chemicals, and unit packaging, such as blister packets. The elderly and those with disabilities have a challenge with child-resistant packaging. Regulations require package and performance tests to be child-resistant and senior-friendly. Certain standards for special packaging like ISO 8317 Requirements and testing procedures for re-closable packages, EN 862 (2005), EN 14375 (2003), ISO 13127 Mechanical test methods for re-closable child-resistant packaging, ASTM D3475 Standard Classification for Child-Resistant Packages (CRPs). Use of CRP Indices such as Package Type (e.g., Aerosol over cap), ASTM Type (e.g., re-closable packaging-continuous thread closure). CRP Manufacturer, CRP Name, Regulations in countries (Canada, The Netherlands, United States, United Kingdom). A few myths concerning packaging for children. Results and Conclusion Reckitt Benckiser is requesting the FDA to require not only child-resistant, unit-dosed containers but also to provide educational programs aimed at lowering the likelihood that children would be exposed to the opioid dependency treatment medicine buprenorphine.

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    Ravindra, G. K., Subramaniam, B., & Veeranna, B. (2024). Standards of Child Resistant Packaging: A Regulatory View. Indian Journal of Pharmaceutical Education and Research, 58(4), 1045–1053. https://doi.org/10.5530/ijper.58.4.116