FDA Revises Health System Compounding Guidance, Implementing a More Practical Approach

• February 01, 2022

• Lee Rosebush , BakerHostetler
• Amy Poe , Hall Render Killian Heath & Lyman PC
• Jacob Simpson , Breazeale Sachse & Wilson LLP

As is often the case following a preventable national tragedy, the pendulum of federal regulation tends to swing to maximum oversight and enforcement; it has been no different for the compounding pharmacy industry following the largest public health crisis ever caused by a contaminated pharmaceutical drug.¹ For nearly a decade now, Congress and the U.S. Food and Drug Administration (FDA) have worked attentively to regulate compounding pharmacies by enacting laws and providing industry guidance aggressively aimed at cracking down on compounding pharmacies and avoiding a repeat tragedy. The latest regulatory efforts suggest the pendulum may be swinging toward equilibrium as the FDA attempts to balance the need for appropriate oversight of the drug supply chain with the flexibility of allowing pharmaceutical compounding for patients with unique medical needs that cannot be met with FDA-approved products.² This article reviews the recent history of compounding pharmacy regulation, explains the FDA’s recent revised guidance, and discusses some of the policy issues left unresolved by the revised guidance.

ARTICLE TAGS

• Life Sciences Practice Group
• Life Sciences