Compounding drugs during the pandemic: FDA offers policy clarifications

Regulatory NewsRegulatory News | 07 April 2020 |  By 

In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders.

Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients.

In one of the updates, FDA clarifies that a draft guidance has not taken effect and will be revised. The guidance notes that FDA will not take action against certain entities as long as drugs are distributed only to healthcare facilities that are owned and controlled by the same entity that owns and controls the hospital pharmacy and that are located within a one-mile radius of the compounding pharmacy.

Another update says, “Although federal law specifies a 5 percent limit on interstate distribution of compounded drug products for pharmacy compounders, we do not intend to enforce the 5 percent limit until after the agency has finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it. The MOU is currently in draft form.”

FDA also clarifies guidance from 2018 that says that compounders may compound drugs on FDA’s shortage list or if they have been discontinued or are no longer marketed.

“The agency also does not consider a compounded drug produced by an outsourcing facility as ‘essentially a copy’ if it is identical or nearly identical to an FDA-approved drug that is on FDA’s drug shortage list. The agency also does not intend to take action under this provision if the facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed,” FDA said.

In another new Q&A on manufacturing and the supply chain, FDA explains to potential applicants: “During this interim period, we are utilizing additional tools to determine the need for an on-site inspection to support the application assessment such as reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records ‘in advance of or in lieu of’ on-site drug inspections. If the final determination is an on-site inspection is necessary, an application may receive a Complete Response.”

In addition, FDA said it’s working to address the COVID-19 pandemic by facilitating imports of drugs to potentially treat COVID-19.

Coronavirus (COVID-19) | Drugs


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