FDA Issues Clarification on Compounding Policies

In case you missed it, the FDA sent an email clarifying several compounding policies in response to questions from stakeholders. Of particular importance to compounding pharmacies and outsourcing facilities is the FDA’s position that a compounded drug identical to a commercially available drug is not considered to be “essentially a copy” if the commercially available drug is currently on the drug shortage list.

Policy clarifications:

• The agency’s 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 This draft guidance document was issued for public comment and has not been implemented.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 the agency has finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it. The MOU is currently in draft form.
• The agency does 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.
• 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.

View the Complete Notice on the FDA Website