On January 8, 2014, FDA sent letters from Commissioner Hamburg regarding the pharmacy compounding provisions of the Compounding Quality Act to hospital and other health care facility purchasers and to state officials, including governors, state boards of pharmacy and health departments. The purpose of the letters is to inform these important stakeholders of the recent passage of new federal legislation affecting the oversight of compounded human drugs, and to encourage them to take steps to encourage compounders that produce sterile drugs to register with FDA as outsourcing facilities.
As required by the new law, FDA has posted a list of facilities that have registered as “outsourcing facilities” under the new law. In addition to posting the list, FDA has provided information about the status of the facilities and what it does and does not mean to be a registered outsourcing facility.
On July 11, 2016, FDA issued a notice to industry announcing a change in its procedure for inspections of certain human drug compounders effective August 1, 2016.
- Notice to Industry regarding procedure for inspections of entities that are seeking to compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 34KB)