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.
Recent Announcements and Actions
FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products FDA issues guidance on prescription requirement under section 503A FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals FDA proposes six bulk drug substances for inclusion on the 503A bulks list 2016 Meeting Materials, Pharmacy Compounding Advisory Committee FDA Establishes Public Docket on Drug Compounding