Compounding pharmacies, which customize drugs for individual patients, say the FDA is overstepping its authority and jeopardizing patient access to compounded medications.
The pharmacies say the Food and Drug Administration has misinterpreted Congress’s intent when it enacted the Drug Quality and Security Act (DQSA) of 2013 by not allowing office-use compounding. Office-use compounding is when a pharmacist makes a drug without receiving a prescription and transfers it to a requesting physician to keep on hand for when it is needed by a patient.
The pharmacies also are concerned that the FDA has issued no rules for compounding but only guidance documents, which aren’t legally enforceable.
“Mass confusion has resulted from the usage of guidance documents, and the FDA is definitely circumventing the Administrative Procedure Act (APA) in our opinion,” Cynthia Blankenship, executive vice president of the International Academy of Compounding Pharmacists (IACP), told me. The APA governs how federal agencies propose and establish regulations. MORE >