Drugs | Compounding

A compounded drug product is one made by a state licensed pharmacist or pharmacy pursuant to a valid prescription from a state licensed physician that indicates the compounded drug is necessary for an identified patient. Most pharmacy compounding is conducted using active pharmaceutical ingredients (APIs), although some is performed using finished drug products. Because API importation has become more difficult due to FDA intervention, it has also become more difficult for compounding pharmacies to obtain the necessary starting drug materials to perform their important services for patients in the U.S. However, the industry continues to thrive and imported APIs continue to enter the U.S. market.

There has been substantial litigation between the industry and the FDA over the legitimacy of pharmacy compounding, with cases being appealed all the way to the U.S. Supreme Court. Still, FDAImports.com, LLC is able to help its API manufacturing, API importing, API distributing and pharmacy compounding clients find The Way Through the FDA importation procedures to continue to gain access to critical API materials. For help in understanding these complex regulations and navigating the procedures for lawfully performing pharmacy compounding services or importing materials for compounding, call FDAImports.com, LLC.