On Tuesday, the U.S. Federal District Court for D.C. issued a ruling for summary judgment on behalf of the compounding pharmacies who filed suit against the FDA. Earlier this year, NCPA, with financial support from the NCPA Legislative/Legal Defense Fund, filed an amicus curae brief in support of the compounding pharmacies on behalf of our membership. In its ruling, the court concluded the MOU is a legislative rule and subject to the Regulatory Flexibility Act, which requires executive agencies to consider the impact of their rules on small entities. The court remanded the MOU back to the agency and now the FDA must "either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis," according to the ruling. However, these rulings from the court do not require the FDA to conduct notice and comment rulemaking on the MOU, so NCPA will join other stakeholders in discussions with the FDA to craft a more workable and equitable document which supports compounders and provides access for patients to their needed prescriptions.
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