Gottlieb on new efforts to encourage compounding of better quality drugs under DQSA
In a statement, FDA Commissioner Scott Gottlieb, MD, discussed the importance of FDA oversight of drug compounding.
In a statement, FDA Commissioner Scott Gottlieb, MD, discussed the importance of FDA oversight of drug compounding. He noted that "compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly." Gottlieb said, "As a physician, I understand how important it is for health care providers to have access to compounded drugs when the needs of their patients cannot be met by FDA-approved drugs. Our commitment to implementing and enforcing the Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals." The commissioner said FDA has posted a new report that includes a list of the drugs that entities registered as outsourcing facilities have produced. Outsourcing facilities are required under DQSA to report to FDA, upon initial registration and then twice a year, on the drug products they compounded during the last 6 months. The list is now being made public, in part "to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards," Gottlieb said. He noted FDA is also sharing a guide, "Outsourcing Facility Information," that includes key regulatory information applicable to the outsourcing facilities.