103 Iowa L. Rev. 1245 (2018)

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Abstract

For millennia, pharmacists have used compounding to produce individualized medications that meet specific patients’ needs. Because commercial drugs are not suitable for all patients, some patients rely on compounding as the only viable way to receive their medications. Since compounding pharmacies fill a unique need, the FDA has traditionally given them more freedom from regulation than drug manufacturers. Unfortunately, some drug manufacturers have masqueraded as compounding pharmacies in order to take advantage of this freedom. Such abuse has harmed patients, the most notable occasion being a 2012 meningitis outbreak caused by contaminated drugs. As a result, Congress enacted the Drug Quality and Security Act (“DQSA”). This Act was meant to increase regulation over manufacturers without overburdening compounding pharmacies. However, two provisions of the Act significantly hamper true compounding pharmacies: a ban on office use prescriptions and a severe restriction on pharmacies’ ability to distribute and dispense drugs interstate. Both restrictions prevent patients from being able to access medications that they need. This Note suggests that Congress amend the DQSA to allow compounding pharmacies to distribute some office use prescriptions and remove the restriction on interstate dispensing.