When combining the statistics for aspirin with those for prescription drugs, the staff of the CPSC estimates that special packaging saved the lives of more than 900 children (in the US) since the requirements went into effect in the early 1970's. - www.cpsc.gov
What does 16 CFR Part 1700 and ISO 8317 compliance mean to me?
ISO (International Organization for Standardization) is a standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. ISO 8317 refers to the international Child-resistant packaging -- Requirements and testing procedures for re-closable packages.
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation. Code of Federal Regulations title 16 section 1700 refers to Poison Prevention Packaging.
The Poison Prevention Packaging Act (PPPA), enacted in 1970, requires a number of household substances to be packaged in child-resistant packaging. The packaging required by the PPPA must be designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly... Since the regulation has been in effect, there have been remarkable declines in reported deaths from ingestions by children of toxic household products including medications.
Before the Poison Prevention Packaging Act (PPPA) was enacted in 1970, poisonings by common household substances, including medicines, had long been considered by pediatricians to be the leading cause of injuries among children under 5 years of age. At one point, state death certificates reported about 500 fatalities a year in children under 5 due to poisoning caused by unintentional ingestion of drugs and household products. -www.cpsc.gov
For further regulation guidance, please visit the United States Consumer Products Safety Commission website relating to the Poison Prevention Packaging Act (PPPA): https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/PPPA
“The purpose of the PPPA is to protect children under 5 from poisonings and deaths that can occur when children open containers of hazardous products and access the contents.”
How does this affect the compounded prescriptions my pharmacy dispenses?
By not complying with the PPPA, you increase your practice’s liability, increase the chance that a young member of your community could ingest a potentially lethal prescription dose. When using SmartScrippsTM, your pharmacy is in regulatory compliance for that prescription. Also, SmartScrippsTM is a much more professional presentation than traditional molds on the market with increased tamper evidency features.
Why should I be concerned with not dispensing prescriptions in child-resistant packaging?
Doing the right thing should be on everyone’s agenda, especially when it comes to protecting young children. As a highly regarded professional in your community, doing the right thing means aligning your business practices with honesty, integrity, professionalism, response to demand, continuous improvement, and abiding by the regulations on state, federal, and even international levels. At Specialized Rx, we view our SmartScrippsTM child-resistant troche mold as a way you can comply with CFR and ISO regulations for this dosage form not previously available anywhere on the planet.
Every pharmacy now has the means to protect their community, young children, and save lives one script at a time.