In a recent statement, FDA Commissioner Scott Gottlieb, M.D., outlined the steps the agency is taking to ensure the quality of compounded drugs while enabling access to patients in need.
In addition to revising a draft memorandum of understanding (MOU) aimed at increasing the proportion of drugs compounders may ship interstate, the announcement includes critical information for both traditional compounders and outsourced compounding facilities (those registered with the FDA to comply with guidelines under section 503B of the FD&C Act).
In short, traditional compounding facilities will likely come under greater scrutiny from state agencies. The data collected will then be used by FDA to prioritize risk-based federal inspection and enforcement. Outsourced compounding drug facilities will be accountable for meeting current good manufacturing (CGMP) requirements via a risk-based approach with less-stringent requirements for low-risk products to encourage compounders to register and operate as outsourcing facilities.Continue Reading