State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk […]

AOD-9604 503A September 29, 2023 Compounded drugs containing AOD-9604  may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard […]

August 4, 2017 Summary Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced […]

The Compounding Quality Act requires the Secretary to establish a mechanism to receive submissions from state boards of pharmacy concerning certain actions taken against compounding pharmacies […]

FDA’s Compounding Incidents Program aims to help protect the public against poor quality compounded drugs through surveillance and review of complaints, which include adverse event and […]

What is a compounded drug? Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the […]

What is compounding?  Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of […]

FDA Oversight of Compounding Facilities The following table describes some of the documents and actions involved in FDA oversight of compounding facilities: Documents and Actions Description […]