Proposed Compendial Approach to Testing for Burkholderia cepacia Complex (BCC)

United States Pharmacopeia (USP) published a new microbiology test method, USP <60> Tests for Burkholderia cepacia Complex, with an initial effective date of December 1, 2019. This was in response to numerous infections, and subsequent product recalls, linked to BCC species. However, since its initial release, the industry has been largely left to its own devices in terms of implementation. That may be about to change as USP announced on March 29, 2024, a proposal for a major compendial change regarding USP <60>.

There are three major points that USP is proposing:

1. Revise USP <62> Tests for Specified Microorganisms to indicate that a product with a Water Activity (A_w) above 0.6 must demonstrate absence of BCC.
2. Revise USP <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use to reflect the requirements outlined in point 1.
3. Update applicable monographs. USP says they are considering specific reference to USP <60> for higher-risk products.

In addition to the major updates above, USP has proposed to update language in other applicable chapters to align with these updates (i.e., USP <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products). They have also indicated their intention to work closely with the Pharmaceutical Discussion Group (PDG) to ensure global harmonization. For the full official USP announcement, see this link.

Did we see this coming?

The short answer is, “yes”. Since it initially became effective in 2019, USP <60> has been a hot topic of discussion. The United States Food and Drug Administration (FDA) now had a compendial chapter to point to when reviewing drug applications, and auditing facilities, and concerns about B. cepacia Complex came up. However, many companies were either slow to implement USP <60> themselves or were simply unaware of how to determine whether they needed to. As such, FDA inspectors were finding that many facilities did not have sufficient testing programs in place to demonstrate control of BCC. In conversations with FDA inspectors, the general implication has been, increasingly, “if your product contains a significant amount of water, you need to be testing per USP <60>”. This proposed update from USP seems to support that goal.

What does this mean for you?

Certainly, if you are manufacturing drug products, and you are not testing your products per USP <60>, you need to begin preparing to implement that testing now. While the comment period for the proposed update is open until June 27, 2024, it is unlikely that the main takeaway (demonstrating absence of BCC for water-based drug products) will change. Beginning the process now will allow you precious time to design/execute suitability studies, update internal specifications, etc.

Will this affect cosmetic manufacturers?

Officially, we don’t know – yet. However, the rollout of MoCRA has indicated that the FDA may begin paying closer attention to microbiological contamination. There have been several cosmetic product recalls linked to BCC. At the very least, it may be reasonable to consider the risk of BCC to water-based cosmetic products.

How can Q Labs help?

Q Labs has been performing USP <60> since its initial inception – prior even to its effective date. Our team of microbiologists stands ready to not only perform this testing, but also to explain the testing, and results. Q Labs, in conjunction with Q Labs Consulting, can also assist with risk assessment, and suitability study design, to make your journey towards compliance as smooth and efficient as possible. Reach out to us today!