Outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act were meant to fill an important gap in patient care: producing compounded sterile preparations at scale, under current Good Manufacturing Practice (cGMP). But in the past year, FDA warning letters to several 503B facilities show how fragile compliance can be, and how quickly lapses in quality and sterility assurance place patients at risk. 3D Illustration of Bacteria. Sterility As

Cosmetic regulation tightened considerably over the past few years, and 2025 is very much a "show your work" moment. Whether you operate in the EU, UK, or US, authorities now expect clear evidence that you know what's in your products, how they're made, and how you monitor safety once they're on the market. Below is a concise, jurisdiction-by-jurisdiction playbook, with the essential documents and actions you should have in place. Man Filling Out Compliance Paperwork. Europea

The cosmetics industry is going through a period of regulatory change. With the Modernisation of Cosmetics Regulation Act (MoCRA) now in force, FDA oversight of cosmetics facilities is sharper than ever. Recent FDA warning letters show that many companies producing cosmetics and over-the-counter (OTC) drug products are still struggling to meet basic compliance expectations. By looking at recent cases, we can see recurring themes: weak testing practices, inadequate quality ov