In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress passed the Drug Quality and Security Act, which amended the federal Food, Drug, and Cosmetic (FD&C) Act and more clearly defined the FDA’s...
The Compounder’s Crash Course to FDA and 503A Exemption Audits The Compounders’ Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared? Protect your business. Join...
The United States Pharmacopeial (USP) Guidelines have identified specific testing requirements that must occur with compounded preparations. These guidelines, which are based in science, were established to ensure patient care and safety. These are not just...
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