On Feb. 25, NCPA, in conjunction with other interested stakeholders in the compounding pharmacy space, filed an amicus curiae brief in the Wellness Pharmacy, Inc. v. Cochran case. At the center of the litigation is the Oct. 26, 2020, memo of understanding between the FDA and approving states which would govern dist¬¬ribution requirements for compounding pharmacies preparing drugs for interstate patients. States that signed the MOU would have Board of Pharmacy reporting requirements to the FDA for compounders shipping more than 50 percent of their products interstate, while compounders in states that did not sign would be limited to 5 percent of their products available for interstate patients. The plaintiffs allege the FDA did not properly follow established protocols. NCPA, on behalf of its compounding members, is concerned over the legality of FDA’s actions and the compliance burdens placed on compounders, especially those close to state borders or with a specialty patient population.
NCPA
