Pharmacies say FDA is going too far in enforcing drug compounding law

Compounding pharmacies say FDA overstepped its authority when it enacted the Drug Quality and Security Act (DQSA) of 2013 by not allowing office-use compounding, which is when a pharmacist makes a drug without receiving a prescription and sends it to a requesting physician to hold onto for when it is needed by a patient.

Compounding pharmacies say FDA overstepped its authority when it enacted the Drug Quality and Security Act (DQSA) of 2013 by not allowing office-use compounding, which is when a pharmacist makes a drug without receiving a prescription and sends it to a requesting physician to hold onto for when it is needed by a patient. The International Academy of Compounding Pharmacists (IACP) says FDA's use of guidance documents rather than issuing rules for compounding has resulted in confusion and believes FDA is evading the Administrative Procedure Act (APA), which governs how federal agencies propose and establish regulations. To fix these issues, IACP wants Congress to pass a bill (H.R. 2871) that stipulates if state law authorizes office-use compounding it would not be considered a violation, and requires FDA to go through rulemaking under the APA. Meanwhile, FDA says its oversight of compounding pharmacies ensures patient safety and allowing office-use compounding could lead to contaminated drug products. FDA also says it is advising more compounding pharmacies to register with the agency as outsourcing facilities, which are allowed to provide compounded drugs for office use because they face higher manufacturing standards, although critics argue facilities are unlikely to pay the fees to do so.