Compounding

Background

In the fall of 2012, there was an outbreak of fungal meningitis caused by contaminated injectable steroids manufactured by New England Compounding Center (NECC). This outbreak resulted in the death of 25 people and caused illness is 344 more. Following the outbreak, then Congressman (currently Senator) Ed Markey released the report "Compounding Pharmacies, Compounding Risk." Additionally, the Government Accountability Office (GAO) released the report "Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight."

Some nuclear pharmacies compound certain radiopharmaceuticals and adjunct drugs, especially during times of shortages, after discontinuation by the manufacturer not related to safety issues, and for other reasons.  Pharmacists have traditionally compounded drugs for individual patients pursuant to a prescription from the patient’s care‐giving physician. Such practice is specifically allowed under state laws governing the practices of pharmacy and medicine. Hence, nuclear pharmacists similarly may compound radiopharmaceuticals and adjunct drugs pursuant to a prescription from the authorized user physician responsible for performing the nuclear medicine procedure.

Current Status

The NECC outbreak prompted several pieces of legislation to be introduced in Congress to help regulate and prevent future outbreaks. In response to these bills, SNMMI met with the Food and Drug Administration's (FDA) Office of Regulatory Policy on April 30, 2013 and followed up with a comment letter.   On September 28, the House of Representatives approved a new bill, H.R. 3204, the Drug Quality and Security Act which was introduced by Rep. Fred Upton (R-MI). Following several delays caused by proposed amendments to the bill, the Senate also passed H.R. 3204 by voice vote on November 18. President Obama signed the bill on November 27 as Public Law No: 113-54.

The legislation clarifies the confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states. Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.

On November 26, 2014, SNMMI, in conjunction with the American Pharmacists Association, the Council on Radionuclides and Radiopharmaceuticals, the National Association of Nuclear Pharmacies and United Pharmacy Partners, Inc., submitted a consensus statement to the FDA regarding the distinction between radiopharmaceutical compounding and preparation. Along with the statement, we also provided recommended definitions of compounding, preparation and minor deviation. These documents are in response to the Listening Session on Radiopharmaceutical Compounding held by the FDA on September 24, 2014. The Listening Session generated many inquiries from the FDA, particularly on the need for specific terms and definitions which SNMMI hopes FDA will use for the development of a guidance document.

SNMMI's position statement "Use of Compounded Radiopharmaceuticals and Adjunct Drug Preparations" can be found here.