FDA releases guidance on compounding beta-lactam products in shortage

Regulatory NewsRegulatory News | 22 November 2022 |  By 

The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam oral antibiotic suspension products.
The agency said it has been asked to clarify how compounded versions of products from FDA-approved tablets and capsules currently in shortage can be prepared, as FDA’s insanitary conditions guidance states beta-lactam drugs are required to be processed with “complete and comprehensive separation from non-beta-lactam products.”
FDA said that amoxicillin oral antibiotic suspension products have reportedly seen increased demand and amoxicillin oral antibiotic powder for these suspension products is currently listed in FDA’s drug shortage list.
“The current shortage of amoxicillin oral antibiotic powder for suspension products and increased demand for beta-lactam oral antibiotic suspension products could lead to potentially serious or life-threatening situations in particular in the pediatric population, especially during the upcoming fall and winter months when the incidence of upper and lower respiratory infections is expected to peak,” FDA wrote in its guidance. “Therefore, based on risk management principles, in order to address access concerns while also minimizing the potential for cross-contamination and the resulting hypersensitivity or allergic reactions, FDA intends to prioritize its regulatory and enforcement actions regarding the preparation of beta-lactam oral antibiotic suspension products that appear on FDA’s drug shortage list by compounders under section 503A.”
FDA said it would “prioritize its regulatory and enforcement actions with respect to the insanitary conditions provision to focus on the potential for harm to the public health, taking into consideration the public health need for beta-lactam oral antibiotic suspension products.” Specifically, the agency will focus on taking enforcement action against compounders that do not use FDA-approved beta-lactam tablets and capsules rather than bulk drugs; do not use dedicated or disposable equipment, utensils and personal protective equipment and segregating them from materials used to prepare non-beta-lactam products; follow proper cleaning procedures; prevent product dust from forming by wetting it with suspension vehicle and trituration; and following appropriate expiration dates and storage conditions.
Responding to FDA’s guidance, the Alliance for Pharmacy Compounding (APC) said it told the agency approximately three weeks ago that FDA’s guidance on insanitary conditions made it difficult for compounders at hospital and retail pharmacies to step in and help mitigate the suspension shortage because of a requirement for compounders separate beta lactams from non-beta lactam products.
“Both hospital and retail pharmacies knew they had the ability to compound amoxicillin suspension from commercially available tablets or capsules,” Scott Brunner, CEO of the APC, said in a statement. “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.”
Brunner applauded FDA’s ability to act quickly on this issue.
“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,” he said.
In other compounding news, FDA recently outlined oral arginine hydrochloride (HCl), oral lysine HCl and intravenous lysine HCl combined with single-ingredient intravenous arginine HCl as bulk drug substances it is proposing to include in its 503B Bulks List, while proposing to exclude etomidate, furosemide and rocuronium bromide from the list.
503B bulks list notice


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