The Compounding and Pharmacy Practices Branch of the United States Food and Drug Administration (FDA)

At the FDA, the Office of Unapproved Drugs and Labeling Compliance, Division of Prescription Drugs, Compounding and Pharmacy Practices Branch is responsible for compliance and enforcement issues relating to compounding.  More specifically, according to the FDA website, the Compounding and Pharmacy Practices Branch responsibilities include: 

• Working cooperatively with states to oversee compounded drug products and protect consumers from harmful compounded drugs
• Directing field inspections and investigations and recommending, directing and/or coordinating case development and compliance actions relating to compounded drug products and other related pharmacy practices.
• Providing enforcement and litigation support and guidance for compounded drug products and other related pharmacy practices
• Reviewing and developing legislative proposals and implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities related to pharmacy compounding and other pharmacy-related issues.
• Using risk based assessments to identify and prioritize compounded drugs for regulatory action and developing compliance strategies to address violations.