Controlling the bacteria Burkholderia Cepacia Complex (BCC) in non-sterile pharmaceutical products has received increased attention in recent years. BCC has now been classified as an “objectionable organism” by the industry and will need to be controlled accordingly. Pharmaceutical products that are contaminated with BCC may pose serious consequences for vulnerable patients (e.g., those with a compromised immune system, particularly Cystic Fibrosis). BCC has been shown to be resistant to traditional non-sterile drug product preservatives which can lead to small quantities fermenting in small pockets of drug product.
Due to the risks, FDA released updated communications recently1,2, in conjunction with a 2023 update to USP <3> (Testing of Topical and Transdermal Drug Products)3 which are now asking for suitable controls be put into place for non-sterile water-based products. Much of this control is centered around USP <60> – Microbiological Examination of Nonsterile Products—Tests for B. Cepacia Complex.
There have also been an increased number of FDA response letters asking for risk assessments and/or control strategies for BCC in topical drug products. Specifications and control of BCC in topical products should be considered during development.
- FDA Guidance for Industry. Microbiological Quality Considerations in Non-Sterile Drug Manufacturing Draft. September 2021. Docket Number: FDA-2021-D-0432. Issued by: Center for Drug Evaluation and Research https://www.fda.gov/media/152527/download
- FDA Drug and Safety Availability (Notification). FDA advises drug manufacturers that Burkholderia cepacian complex poses a contamination risk in non-sterile, water-based drug products. April 21, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile
- United State Pharmacopeia (USP) 〈3〉 Topical and Transdermal Drug Products—Product Quality Tests. doi: https://doi.org/10.31003/USPNF_M4033_05_01