By Adam West, Course and Curriculum Manager at CriticalPoint
FDA’s “current thinking”
The Insanitary Conditions at Compounding Facilities Guidance for Industry is intended for “compounding facilities” that prepare drugs at any capacity. The Food and Drug Administration (FDA) states that “guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
In reality, inspection lenses from the FDA are based on applicable laws (Code of Federal Regulations [CFR]) and determine compliance by defining how the CFR laws are violated. In a way, guidance documents combine these features by providing recommendations on specific practices and describing the lens through which facilities will be inspected either using observed examples or identifying a law violation.
So, while the “recommendations” of a guidance are just that, they provide the what and why behind the “current thinking” and how something violates law. Essentially, familiarizing yourself and following FDA guidance better protect your compounding facilities from the lens of FDA and keeps you off its radar.
How does the FDA and the insanitary conditions document pertain to hospital pharmacy?
Drugs cannot be prepared, packed, or held under insanitary conditions, regardless of whether they are made in accordance with section 503A or section 503B. Traditional (503A) hospital pharmacies that prepare compounded drugs are exempt from current good manufacturing practices (cGMP) requirements so long as they produce drugs in accordance with the conditions of section 503A.
When compounders prepare drugs under insanitary conditions, they violate the terms of section 503A and, therefore, are no longer exempt and subject CGMP requirements.¹ Because of the violation, these facilities may become subject to the full lens of CGMP expectation.
Insanitary conditions in 503A facilities are more common than you think
Hospital pharmacies likely have at least one insanitary condition present. In fact, there are probably more than a few. Insanitary conditions develop through repeated daily activity or poor practices. Is this just standard practice because they aren’t held to higher standards? No. There is no exemption of practice between minimum and more stringent standards like CGMP when it comes to insanitary conditions.
The insanitary guidance provides actual scenarios defined as insanitary conditions that were observed through inspection. But what is an insanitary condition? The FDA guidance defines insanitary conditions as “conditions that could cause a drug to become contaminated with filth or rendered injurious to health. The drug itself need not actually be contaminated.” Essentially, if the conditions of the compounding area look icky, it probably is icky.
You may be picturing in your mind a filthy-looking facility. However, that’s not really the case. Observations may include something that could lead to an insanitary condition but has not yet happened.
Compounding facilities must have a proactive approach to prevent insanitary conditions
Insanitary conditions aren’t limited to what the facility physically looks like (although, traditional pharmacies are more likely to be deficient in this area). A perceived insanitary condition or a literal one can look like many things, including improper aseptic practices or inadequate cleaning and disinfection. CriticalPoint strongly recommends that pharmacy designated persons obtain the free insanitary conditions guidance and study the example conditions. The next three steps are easy!
- Implement a process that serves as a tool to identify conditions in your facility that is or could lead to an insanitary condition.
- Remove potential risks in your facility that create an environment for insanitary conditions
- Perform ongoing analysis and frequent inspections that act as preventative and corrective actions for insanitary conditions.
The good news is that everyone on your staff roster can do this with you. The FDA considers everyone to be responsible for helping to identify these types of risks. Evaluation of conditions can happen anytime of the day or during cleaning and by those who have oversight of compounding practices.
Click here to learn about the types of insanitary conditions in traditional pharmacies and how to identify them, remediate them, and prevent them in the future.
View our Designated Person Administrative Best Practices
References
¹Compounding Inspections and Oversight FAQs May 2024, retrieved 11/11/2024
Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020