November 19, 2022

We urged, FDA acted

Agency issues guidance on beta lactam compounding in shortage

With amoxocillin suspension on FDA’s drug shortage list, on Friday the agency released a final guidance document stipulating minimum steps compounders who compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

APC first alerted the agency three weeks ago that compounders’ ability to help mitigate the amoxicillin suspension shortage and get life-saving medicine to children in need was impeded by provisions in FDA’s Insanitary Conditions Guidance. That guidance requires compounders to “completely and comprehensively separate beta lactams from non-beta lactam products”—a provision with which many pharmacies, both hospital and retail, could not comply.

“Both hospital and retail pharmacies knew they had the ability to compound amoxicillin suspension from commercially available tablets or capsules,” said Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding. “But they were unable to meet that requirement of complete and comprehensive separation from other products—and so they were concerned, rightly, about the potential for regulatory action to be taken against them for serving the need of their patients.”

The final guidance states:

“FDA’s insanitary conditions guidance describes the processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products as an example of an insanitary condition the Agency has observed. However, during the time that beta-lactam antibiotic powder for oral suspension products are on the FDA shortage list … compounders under section 503A of the FD&C Act that prepare beta lactam oral antibiotic suspension products that appear on FDA’s shortage list without complete and comprehensive separation from non-beta-lactam products should take at least the following minimum steps to mitigate the potential risk of cross-contamination and reduce risk to patients.”

The guidance adds that the agency will “prioritize its regulatory and enforcement actions” if the nine prescribed steps “are not all followed when preparing beta-lactam oral antibiotic suspension products that appear on FDA’s shortage list.”

“This guidance is a remarkably rapid and helpful response from the agency, and I know compounders will take seriously their commitment to mitigate risks to get these medications to the children who need them,” said Brunner. “As with the help 503A compounders provided in sourcing shortage COVID drugs to hospitals under temporary FDA guidance back during the pandemic, this is another episode of ‘Compounders to the rescue!’”

As reported in a recent email message to APC members, FDA is interested in the data APC is gathering so that it can assess the scope of the problem. Please complete our amoxicillin survey.