The Latest News on Compounding from the FDA

February 2017 - Vol.14 No. 2 - Page #1

This past November marked 3 years since Congress enacted the Drug Quality and Security Act (DQSA), including the related Compounding Quality Act. In January, the FDA released a Human Drug Compounding Progress Report (

with the goal of clarifying certain points in the DQSA, and noting that the Administration has devoted significant resources to implement and enforce the compounding-related provisions of the related acts, citing the numerous Corrective Action Plans and voluntary recalls that have resulted from FDA inspections as proof of the positive impact their efforts have had on public health.

According to the report, over the past 3 years, the FDA has taken the following actions, among others:

  • Significantly increased its inspections of facilities where drugs are being compounded and taken appropriate regulatory actions in response to violations of the law that put patients at risk 

  • Issued numerous policy documents, including draft and final guidance documents, and proposed and final regulations
  • Convened advisory committee meetings to obtain advice on scientific, technical, and medical issues concerning drug compounding 

  • Obtained input from stakeholders through a variety of different mechanisms 

Further, the FDA encourages hospital pharmacy’s use of outsourcing pharmacies given the increased safety associated with products sourced from 503B-designated facilities, versus products that are not produced under cGMP requirements. While the FDA plans to focus on inspecting 503B facilities—with state officials focusing on 503A compounding practices—the Agency also plans to expand their collaboration with state officials to identify facilities operating as manufacturers without appropriate licensing, as well as facilities with unsafe practices. With this in mind, we expect to see additional draft guidance and new policies coming from the FDA in the near future.

Regulatory focus on pharmaceutical compounding is unlikely to abate any time soon; thus, it is vital that pharmacy directors remain abreast of evolving requirements.

All the best,

R. Mitchell Halvorsen

P.S. The staff of PP&P would like to recognize and congratulate our friend, Robert Granko, PharmD, MBA, pharmacy director at the Moses Cone Memorial Hospital in North Carolina, for his receipt of this year’s Distinguished Service Award in the Section of Pharmacy Practice Managers at ASHP’s Midyear Clinical Meeting. As a long-standing author and advisor for PP&P, this award comes as no surprise to us. Bob is a thoughtful, intelligent, and inspiring leader, and his open embrace of new practices and technologies raises the level of pharmacy practice for all. We are proud to call him a friend, and consider this a well-deserved honor.


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