Enlisting an import agent is a basic requirement for importers of FDA-regulated products. Import agents are the frontlines of communication with the FDA, assisting with the submission of required registrations and listings as well as support with questions posed by...
Sterility testing and assurance are critical regulatory compliance requirements for 503B facilities that perform sterile compounding according to USP <797>. Subject to section 503B under the Federal Food, Drug, and Cosmetic (FD&C) Act, 503B facilities...
MoCRA is here, and it’s reshaping the U.S. cosmetics industry. The MoCRA law covers a wide range of cosmetics and personal care products, and introduces new provisions and grants new powers to the FDA for regulating cosmetic products in the United States, including...
Stability testing is the process of evaluating a product to ensure that key attributes stay within acceptable specifications during the aging process. Physical test parameters include appearance, color, odor, viscosity, pH, and package compatibility as analyzed using...
OTC and OTC-drug crossover products require stability testing, per FDA regulations. And, while FDA doesn’t mandate stability testing for cosmetics, it is the manufacturer’s responsibility to ensure product safety prior to marketing the product, and many...
![Guide to OTC & Cosmetic Stability Testing [+ Free Cheat Sheet]](https://certified-laboratories.com/wp-content/uploads/BUR_Stability_1687-1-min-1080x675.png)
