By: Jeff S. Gibson, Attorney
Tainted steroid injections manufactured by the New England Compounding Center in 2012 cast a spotlight on compounding pharmacies and raised alarms. Hundreds of people across the United States were sickened and 64 people died after being exposed to fungal meningitis through contaminated steroid injections.
The public demanded answers from the FDA about how it could allow these drugs to be distributed. The answers weren’t that simple.
What is a compounding pharmacy?
Prior to the fungal meningitis outbreak, most people were not aware of what a compounding pharmacy was or how it was regulated. These pharmacies make custom medications for patients by blending drugs and ingredients as ordered by doctors. Custom medications can help patients who have allergies to certain drug ingredients by creating a special formula to meet their needs. This is considered to be different from a drug manufacturer that produces drugs on a larger scale and has different regulations.
State Pharmacy Board v. FDA Oversight
Compounding pharmacies are regulated by individual state pharmacy boards. Inspections of facilities are conducted by state regulators. However, because compounding pharmacies create drugs, the Food and Drug Administration (FDA) also has oversight of these drug makers.
Legislation was passed in 1997 to put drug compounding facilities under the FDA’s regulatory structure through the Food and Drug Administration Modernization Act. However, federal courts offered differing interpretations about which aspects of the Act applied to compounding pharmacies. The lack of a definitive regulatory authority allowed compounding pharmacies the leeway to ignore inspection report recommendations and possibly put patient safety at risk.
Drug Quality and Security Act
After the fungal meningitis outbreak, lawmakers and regulatory agencies sought ways to increase patient safety by detailing requirements for oversight and operations for compounding pharmacies and setting this information into law. The Drug Quality and Security Act was passed into law in November 2013. The act specifically provides authority to the FDA to regulate compounding pharmacies. It also provides definitions of neighborhood pharmacies, compounding pharmacies, and drug manufacturers.
This act has provisions for ‘outsourcing facilities’. These outsourcers are defined as compounders who create drugs on a larger scale than a neighborhood pharmacy but less than a full drug manufacturing facility. Outsourcing facilities are required to pay a $15,000 yearly registration fee to the FDA, and submit a report twice a year to the FDA regarding all the drugs compounded at the facility. Lawmakers and regulatory bodies intend for these provisions to provide more transparency and accountability for compounding facilities.
The FDA issued a draft guidance that describes the FDAs intention regarding provisions of the Act that require rulemaking or other actions to implement. Once these guidances are finalized compounders, health care professionals, and patients can all have a greater understanding of the regulations put in place to protect patient safety and avoid future tragedies like the fungal meningitis outbreak in 2012. Any questions? Feel free to contact us here.