Who we are
The Office of Compounding Quality and Compliance (OCQC) 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.
What We Do
- Work to protect consumers from unsafe compounded drugs.
- Develop and implement the Compounding Quality Center of Excellence focused on improving the quality of compounded drugs.
- Develop and implement policies and compliance strategies to protect the public health by helping assure the quality of compounded drugs.
- Evaluate incidents, compliance, regulatory and enforcement actions related to compounded drugs.
- Review bulk drug substances nominated for use in compounding.
- Collaborate with state regulators in the development and implementation of compliance and enforcement strategies related to compounded drugs.
- Issue compounding risk alerts to inform stakeholders about risks associated with compounded drugs, including information on adverse events, outbreaks or drug quality.
- Division of Compounding I
- Division of Compounding II
- Division of Compounding Policy and Outreach
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5271
Silver Spring, MD 20993-0002