Compounding Policy Clarifications - Drug Information Update

We have received many emails from stakeholders about a few of our policies and we wanted to clarify a few things: Our guidance for hospital and health systems, which includes the “one mile radius” provision, is still in draft and we are planning to issue a revision. This draft guidance document was issued for public comment and has not been implemented. 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 we have finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it. The MOU is currently in draft form. We do not consider drugs that are on FDA’s shortage list or that have been discontinued and are no longer marketed as “commercially available” under the “essentially a copy” provision for pharmacy compounders. We also do 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. See human drug compounding and drug shortages for more information. Please email compounding@fda.hhs.gov with questions.