FDA Touts the Benefits of Outsourcing Facility Registration to State Officials and Hospital Purchasers of Compounded Medications

January 9, 2014

By Karla L. Palmer – 

FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 Stat. 587), specifically Title I, the Compounding Quality Act.  FDA’s stated purpose of the letters is to urge state officials and hospitals to encourage outsourcing facilities to register with FDA as outsourcing facilities.  The letters recount a brief history of events leading to the legislation, noting that new “problems continue to be identified at compounding pharmacies across the country, which number over 15,000.” (citing 2012 NCPA Digest In-Brief. Retrieved November 14, 2013, from National Community Pharmacists Association (“NCPA”)).

The letters describe generally requirements for voluntarily registering as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  FDA notes that an outsourcing facility can qualify for exemptions from FDA approval requirements and the requirement to label products with adequate directions for use, but it still must comply with current good manufacturing practice (“cGMP”) requirements.  FDA reminds hospital purchasers that when a drug is FDA-approved, FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process.  Because compounded drugs do not go through the drug approval process, such drugs do not provide such assurance.  Thus, compounded drugs, says FDA, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient. 

In the letter to state officials, Dr. Hamburg asks them to consider how they can encourage compounding pharmacies located out of state that ship compounded sterile drugs into the state to register with FDA as outsourcing facilities.  FDA notes that registration of pharmacies as outsourcing facilities will help FDA identify and more effectively regulate these facilities.

As to hospital purchasers of compounded products, Dr. Hamburg tells them that they can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to register as outsourcing facilities. Once they register, such facilities and the patients they serve, says FDA, can be assured that FDA will inspect these facilities on a risk-based schedule, hold them to CGMP requirements, monitor the adverse event reports they are required to submit to the agency, and require appropriate labeling.  As required by the new law, FDA has also posted a list of facilities that have already registered as “outsourcing facilities.”