USA – Compounding Drugs During the Pandemic: FDA Offers Policy Clarifications

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In one of the updates, FDA clarifies that a draft guidance has not taken effect and will be revised.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…