FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)
Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.
FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
Questions? Email FDA’s compounding team at firstname.lastname@example.org.
Learn more about FDA’s efforts to improve the quality of compounded drugs, primarily those made at outsourcing facilities, through the Compounding Quality Center of Excellence.
Find information about federal law and FDA policies that apply to compounding and other activities compounders undertake. Read section 503A and section 503B of the Federal Food, Drug, and Cosmetic Act. Learn more about federal law provisions that apply to human drug compounding and FDA policies on compounding and other related activities. Find a list of compounding policy documents and information about the Pharmacy Compounding Advisory Committee. Also, find clarifications on FDA's policies.
Find links to compounding inspections, recalls, and other actions, as well as descriptions of some of the documents and actions involved in FDA oversight of compounding. Learn about the risks associated with certain compounded drugs. Also, find answers to frequently asked questions about FDA inspections of compounders.
Find general information for outsourcing facilities, as well as a list of currently registered outsourcing facilities. Thinking of registering as an outsourcing facility? Find answers to frequently asked questions for entities considering registration, information on facility fees and how to register and submit product reporting information to FDA.
Find information on using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. FDA is working to develop the 503A bulks list and 503B bulks list, which will be updated on an ongoing basis as the agency evaluates bulk drug substances nominated for these lists. Find information to know your bulks supplier because compounding from bulk drug substances presents risks to patients.
Find resources for consumers who use compounded medicines and health care professionals who prescribe compounded medicine, including answers to frequently asked questions and how to report adverse events and product complaints to FDA.
Find information regarding FDA and state collaboration to oversee compounding, as well as resources for state regulators, including information on the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs.
Find information about external partnerships for compounding research.