The Food and Drug Administration (FDA) recently issued a Memorandum of Understanding (MOU) related to the interstate distribution of compounded drugs. If a state Board of Pharmacy or other appropriate state agency decides to enter into this MOU with the FDA, pharmacies and physicians that compound drugs in that state will be subject to specific limits on the quantity of compounded products they may distribute out of state. Members in several states where the MOU is under consideration expressed concern as to how it might impact the compounding of allergen extracts. They are particularly concerned this might curtail the ability of allergists to send vial sets used in allergen immunotherapy to patients out of state.
It is important to understand that the FDA’s MOU does not apply to biologics nor allergenic extracts, and, therefore, we do not believe the MOU will affect the practice of allergy.
NOTE: the FDA issued guidance in 2018 on how it will enforce the law with respect to compounded biologics, including allergenic extracts. This current guidance does not impose limitations on the quantity of allergy treatment sets that can be distributed to patients out of state. It does, however, establish certain conditions for preparation of allergy treatment sets. For a list of those requirements, see page 14 of the FDA guidance.