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By Dylan Herr, Eagle RA/QA Development Manager
To see our recommendations on how to interpret the FDA’s final Insanitary Conditions at Compounding Facilities guidance, please read our more recent blog post “2 FDA Resources That Can Help Protect Patients & Minimize Risk in Your Pharmacy.”
In 2013, Congress passed the Drug Quality and Security Act, which amended the federal Food, Drug, and Cosmetic (FD&C) Act and more clearly defined the FDA’s authority to regulate compounding pharmacies. Under Section 503A of the FD&C Act, compounding pharmacies are eligible for exemptions from certain provisions of the act — such as compliance with good manufacturing practices — as long as they meet specified criteria.
However, 503A compounding pharmacies are not exempt from section 501(a)(2)(A) of the FD&C Act, which states that drugs are deemed to be adulterated if they are prepared, packed or held under insanitary conditions that may render them injurious to health. According to the FDA, insanitary conditions may result in patient harm or death by causing drugs to become contaminated with microorganisms, non-viable filth or the presence of unintended drug components.
In 2016, the FDA issued a draft guidance document entitled “Insanitary Conditions at Compounding Facilities,” which it revised in 2018. The purpose of the guidance document is to provide examples of conditions that the agency deems insanitary in order to assist compounders in identifying similar conditions in their own operations so that they may take appropriate corrective actions.
Insanitary Conditions for Sterile and Non-sterile Drugs Insanitary conditions are not limited solely to sterile drug compounding. In fact, the guidance document states that although sterility is not required for non-sterile products, a non-sterile drug that is contaminated with microorganisms, non-viable filth or unintended drug components may still result in patient harm. Section (A)(1) of the guidance document provides examples of insanitary conditions that are applicable to both sterile and non-sterile drug products and production areas.
For example, the FDA considers these to be insanitary conditions for sterile and non-sterile drug production areas: Vermin, such as insects or rodents, or other animals, such as dogs
Insanitary Conditions for Sterile Drugs The guidance document then provides examples of insanitary conditions that are only applicable to sterile compounding, grouping these examples into the following categories: gowning and aseptic practices, equipment and facilities, sterilization, cleaning and disinfection, and other. For more details, we at Eagle strongly encourage all compounding facilities to read the 2018 draft guidance document.
It is important to note that insanitary conditions are not limited solely to the physical compounding facilities. Many of the examples of insanitary conditions provided are related to personnel work practices and habits. It is important for pharmacy supervisors and owners to assess the clean room behavior of their sterile compounders and correct any poor aseptic practices or insanitary conditions observed. For example, the FDA considers the following to be insanitary:
The guidance document also outlines a number of insanitary conditions that are related to the facility’s processes and procedures. For example, the FDA considers the following to be insanitary:
FDA Regulatory Oversight of Insanitary Conditions The presence of insanitary conditions in compounding pharmacies seems to be a focus of the FDA’s recent inspections of 503A facilities. In the last quarter of 2018, nearly all of the Form 483s issued by the agency to 503A compounding pharmacies included at least one observation related to conditions that the FDA considers insanitary.
It is also important to note that the items listed in the guidance document are only intended to be examples. The agency emphasizes that “these examples do not constitute an exhaustive list of insanitary conditions that could be present in a compounding facility; other conditions described in this guidance may be considered insanitary” (p. 3).1 Therefore, it is imperative that when compounding pharmacies evaluate their own operations, they do not limit the assessments solely to items that are listed in the FDA guidance document. Recent 483s issued to 503A compounding pharmacies include inspectional observations that seem to be related to insanitary conditions not explicitly cited in the guidance document. For example, one pharmacy received an inspectional observation for using paper towels in the non-sterile compounding area. While not prohibited by USP Chapter <795> or included in the FDA guidance document, paper towels may shed particles and result in non-microbial contamination, which the agency would consider to be insanitary.
We at Eagle strongly recommend that all compounding pharmacies familiarize themselves with “Insanitary Conditions at Compounding Facilities” and assess their operations. This assessment should include an evaluation of physical conditions, processes and procedures, and personnel practices to determine whether conditions that may be considered insanitary are present. If any such conditions are identified, we recommend that the pharmacy define and implement corrective actions, and routinely monitor their operations to evaluate the effectiveness of these corrective actions.
If you have any questions about insanitary conditions, please contact Eagle at 800.745.8916. Our team of experts can provide a range of consulting services to help evaluate your operations and meet your needs.
Dylan Herr joined the Eagle team in 2017. Before that, she worked for five years as the practice manager and compliance officer of a 503A compounding pharmacy. In this role, Dylan led the development and implementation of quality systems and standard operating procedures in addition to managing daily operations of the home infusion practice. Dylan also led the pharmacy through NABP, BOP and FDA inspections, and helped it achieve ACHC and PCAB® accreditation. Her formal education includes a bachelor’s degree in anthropology from Dartmouth College.
A version of this article previously appeared in PCCA’s members-only magazine, the Apothagram.
Reference 1. U.S. Food & Drug Administration. (2018). Insanitary conditions at compounding facilities: Guidance for industry. Retrieved from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm514666.pdf