The FDA & Drug Source Control

On my second block of rotations, I spent six weeks in the Food and Drug Administration, where I learned so much about the regulatory process and the drug supply chain. I explored the careers pharmacists were pursuing within the Administration - a professional pathway that is not highlighted during our didactic courses. In one of these roles,  pharmacists commonly work as field inspectors, ensuring the quality and safety of our food and drug products.


In Thailand, given the relatively low number of pharmacists, the regulatory sector is a much larger percentage of the jobs taken by pharmacy graduates, about 7.5% in a 2006 survey. Last week, we heard from a district office of the Thai FDA, speaking about their role in consumer protection. In truth, this was not much different than the US version of the job, checking for GMP and issuing guidance and warnings when manufacturers were not up to code.

As pharmacists, we take much of the work of the FDA for granted. While we undoubtedly review the evidence for safety and efficacy of new medications, we rarely think about things like source control, GMP and fraudulent medications, even when we play an active role in purchasing and inventory. This work has been outsourced to our FDA and our wholesalers. In Thailand, I’ve realized that even clinical pharmacists are much closer to the drug supply chain than your average American pharmacist. Many of the hospitals we’ve visited have included a summary of their process for source control and verification in their system overview, and some even have extensive production facilities themselves.

At Chiang Mai University hospital, the pharmacy produced antiseptic solutions, maintenance fluids and even its own concentrated electrolytes. At Chao Phraya Abhaibhubate, they had a GMP production facility to make ready-to-use capsules, syrups and topicals based on traditional Thai herbal remedies.

Pharmacy education in Thailand still includes a pharmacy science track that prepares pharmacists to work in quality control in industry or for the Thai FDA. It’s amazing that while Thai pharmacists are reaching for more clinical roles in their hospitals and communities, they still maintain such a prominent role in the manufacture and distribution of medications.