Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.
While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.
Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.
This document serves as a voluntary guideline to assist manufacturers of dietary supplements with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US FDA 21 CFR §111.
CHPA generally supports prohibitions on animal testing while allowing exemptions in select research areas deemed critical to substantiating human health and safety based on federal or state regulator evaluations.
