What Causes Insanitary Conditions in Compounding Pharmacies?

Contaminated drugs can cause serious harm to patients and even deaths. Compounding pharmacies have a responsibility to ensure that the drugs they mix are reliable and safe for consumer use. Unfortunately, this is not always the case.

In 2012, there was a multistate outbreak of fungal meningitis due to contaminated steroid injections. The contamination occurred at a New England Compounding Center. It caused more than 64 deaths in over 20 states.

As a result of this contamination and outbreak, Congress passed the Drug Quality and Security Act in 2013. This Act regulates compounding pharmacies and the conditions in which they can operate. Insanitary conditions may result in patient harm. That is why compliance with good manufacturing practices are necessary to ensure consumer safety.

In 2016, the FDA issued a guide called “Insanitary Conditions at Compounding Facilities.” This guide helps agencies and compounding pharmacies understand the insanitary conditions that could lead to patient harm. It also outlines examples of conditions that the FDA considers to be insanitary. Using this guide can help compounding pharmacies take appropriate corrective actions.

Identifying Insanitary Conditions

The term “insanitary” describes something that is not sanitized. This does not mean that the practices or conditions themselves are dirty or unhealthy. It just implies that the conditions lack sanitation. In a compounding pharmacy, this lack of sanitation can result in the contamination of drugs.

There are two types of drugs made in pharmacies: sterile drugs and non-sterile drugs. Contamination of these drugs can occur in many different ways. It is important for compounding pharmacies to learn to identify insanitary conditions quickly.

Examples of Insanitary Conditions

Humans are the #1 source of contamination in a cleanroom. As such, many of the FDA guidelines focus specifically on personnel and sterile procedures. Section (A)(1) of the FDA guide provides examples of insanitary conditions that could lead to serious patient harm. Some of these include, but are not limited to:

· Presence of animals, vermin, or insects

· Visible microbial contamination

· Rust, glass shavings or hair in a workspace

· Active construction

· Evidence of water leakage or standing water

· Improper sterile procedure

· Failure to disinfect supplies

· Moving too quickly into ISO 5 areas

· Failure to glove or use a sterile gown

· Exiting or re-entering classified areas without replacing all gowning apparel

· Gowning or gloving in non-classified areas

· Lack of environmental monitoring

· Lack of personnel sampling

· Use of non-sterile disinfecting agents

How Can Your Compounding Pharmacy Prevent Insanitary Conditions?

All compounding pharmacies should familiarize themselves with the FDA guide. They should use this guide to assess and analyze their own operations. This assessment should include a thorough evaluation of all conditions, processes, and procedures. It should also include an assessment of personnel practices. These evaluations can accurately identify insanitary conditions.

Compounding pharmacies should consider consulting an accredited laboratory. With help, they can meet the necessary guidelines for the safe and responsible production of medications. An accredited laboratory can test routine samples. They can also provide feedback and solutions on procedures that may contribute to insanitary conditions. These solutions can help your pharmacy meet regulations and ensure the safety of all consumers.

About the Author Ross Caputo

Ross Caputo has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing. He focuses primarily on process optimization and control.