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The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
The FDA has released a final guidance document on November 18, stipulating minimum steps pharmacies that compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products. The steps include only compounding for 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.
“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 Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding (APC).
The FDA officially listed amoxicillin oral powder for suspension in shortage on its website in late October. The widely-used antibiotic — particularly for a multitude of pediatric infections — is in short supply from several companies due to increased demand, the agency noted.
In addition to amoxicillin, APC members are also reporting growing difficulty in sourcing cephalexin suspension, an alternative to amoxicillin, Brunner told Formulary Watch.
“Whether the shortage ends next month or next year, that’s no comfort to parents of sick children who need the medication now. FDA issued the guidance to authorize a path — within some very tight guidelines — compounders can take to help alleviate the current shortage,” Brunner said.
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,” APC said.
The 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. The regulatory agency requires this separation because of the possibility that cross-contamination could expose penicillins to patients with allergic reactions.
The FDA recently requested the addition of a warning on the labels of amoxicillin products about several rare and serious skin reactions. These reactions were already reported in the adverse reactions section of the labels but given their severity, regulatory officials felt that they should be listed in the Warnings and Precautions section of the label.
“Both hospital and retail pharmacies knew they had the ability to compound amoxicillin suspension from commercially available tablets or capsules,” Brunner said. “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.”
While the guidance is permanent and final, Brunner suspects it will be withdrawn by FDA after the shortage passes.