Research Paper Response

Welcome to February Response:

1. My research paper is on the regulations, fallacies and benefits of compounding pharmacies manufacturing of pharmaceutical drugs in light of the most recent meningitis epidemic.

2. My most valuable source is the actual FDA regulation guide to the production of pharmaceutical drugs in relation to compounding pharmacies. It contrast the standard procedures and safety requirements to that of the New England compounding pharmacies. It also shows the extent to which the FDA can regulate these small scale manufacturing sites.

3. My view is that the current setup of FDA regulations allow for an unnecessary and problematic grey zone. The FDA should not be able to regulate the compounding pharmacies because they are only intended to produce small batches of individualized medicine. However, many compounding pharmacies, like the New England compounding pharmacy that created the contaminated injectables, sell their products across state lines. The state regulatory standards are not up to par to ensure the safety and quality of manufactured drugs. There needs to be some sort of restructuring - i.e. allowing the FDA to regulate if documented interstate commerce of the compounding pharmacies - in order to prevent additional outbreaks.

4. The concept of manufacturing and even the technical jargon is relatively simple compared to the more detailed and specific science. My paper is less about the science behind manufacturing and more on the applications and regulations. A few concepts might need to be explained. For example, I do not think the general public understands what CAPA means. It stands for corrective action, preventative action, an indicator for the level of modifications needed to ensure the safe and  consistent manufacturing of items - particularly pharmaceutical drugs.

5. One of the biggest "whoa!" moments, as you say, was my comprehension to the extent of the negligence of the compounding pharmacists, the board members of this company and the regulatory agencies (both state and federal). The batch of contaminated injectables contained visible fungal particulates, in other words, big chunks of fungus and mold in the supposedly sterile environment. The board members failed to do appropriate due diligence on the miscreant who ran the New England compounding pharmacies after leaving Chicago do to morally dubious actions involving another compounding pharmacy. Additionally, the FDA already knew that the New England compounding pharmacies was in blatant violation of the standard regulations years before the outbreak.