According to a recent update, many compounding medical clinics/offices have been found to be in violation of sections 503A of the Federal Food, Drug and Cosmetic (FD&C) Act or state regulations. With more cases coming to light, the FDA has raised significant concerns around the unsanitary conditions found in these businesses.
Compounding is the practice of creating personalized treatments by mixing, combining, or altering ingredients to produce medication that meets the needs of a particular patient's condition. The FDA constituted the FD&C Act, which includes sections 503A and 503B describing in detail spaces where compounded products can be served to patients safely. Section 503A encompasses compounding pharmacies, where drug products are produced based upon individual physicians and catered towards specific patient preferences and needs. Under this section, compounding pharmacies are also permitted to produce a limited number of batch drugs.
The products supplied are considered sterile and are designated for home use. Meanwhile, Section 503B refers to products that are readily available for hospitals, ambulatory care, and other healthcare facilities.
Compounding medications in unsanitary conditions were highlighted in the press release where products were described to be contaminated with filth and caused harm to health. Medical spas, mobile IV infusion services, and IV hydration clinics were among the businesses suspected of operating under these circumstances. The extent to which these unsanitary conditions occurred in offices was not fully known. However, adverse events have been reported as a result of the drug products manufactured at these facilities.
The FDA press release examined specific cases of unsanitary conditions that supported the agency's decision to raise concerns. Three distinct scenarios for the years 2016, 2020, and 2021 were elaborated. Fungal infections were linked to an oncology medical office in 2016, where patients were infected with Exophiala dermitides, a thermophilic black yeast. Sterile compounding was found to be performed in the office under an inadequate cleanroom design with an ISO-5 classified hood with brownish, soiled contamination on the bottom edges.
In 2020, compounding of drugs intended to be sterile was discovered in a medical clinic that provided services ranging from IV vitamin therapy to laboratory testing, but these services were provided in conditions with peeling laminated wood in the ISO-5-classified cleanroom, compounding personnel who failed to sanitize and dress in appropriate gown-wear, discoloration of high-efficiency particular air filters located in the ISO-5-classified area, and the use of expired active pharmaceutical ingredients.
Lastly, in 2021, a 50-year-old female patient was admitted with suspected septic shock with multiorgan failure caused by Pseudomonas fluorscens after receiving an IV vitamin infusion at her home. The infusion was compounded in a medical clinic known to deliver a plethora of services from IV to hormone replacement therapies. However, similar to the other two cases, the therapies were conducted under unsanitary conditions due to a lack of a certified ISO-5-classified area, among other issues. All of these observed unsanitary conditions added health risks to the drug products being produced, packed, or stored.
The FDA reiterated the importance of compliance to federal and state regulations and stated that it will continue to evaluate these practices and collaborations. They encourage patients and healthcare professionals to report any adverse events or quality issues associated with the use of compounded medications to FDA's MedWatch Adverse Event Reporting program.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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Published February 22, 2022