Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
503B sterile compounding pharmacies are ultimately responsible for their products, even when they outsource quality and sterility testing. Here’s how to ensure your testing partner uses adequate laboratory controls so you can remain compliant and produce safe,...
Dec 5, 2024 | Blog, Cosmetics, FDA Import, Food and Beverage, OTC and Personal Care
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...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
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...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
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...
Dec 5, 2024 | Blog, OTC and Personal Care
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...