FDA updates hospitals on compounding policies

The Food and Drug Administration is clarifying several compounding policies so hospitals and health systems understand what their 503A compounding pharmacies are permitted to do when making or distributing certain drugs. The clarifications include draft guidance for hospital and health systems, including on the not-yet-implemented “one mile radius” provision; and a draft Memorandum of Understanding for interstate distribution of compounded drug products for pharmacy compounders. FDA also say it does not consider drugs that are on its shortage list or that have been discontinued and are no longer marketed as “commercially available” under the “essentially a copy” provision for pharmacy compounders.  

The clarifications of FDA policy, taken together, suggest that hospitals’ 503A compounding pharmacies should be able to compound many of the drugs that are otherwise in short supply during the COVID-19 public health emergency. Similarly, the agency says it 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.