Powers attorney Rebecca Burke wrote an article about the evolving regulatory and legal climate that could impact physician compounding and the potential consequences of such changes.
The article discusses physician compounding of sterile products and policy changes that came about after the 2012 disaster in which 64 patients died of fungal meningitis and 753 were injured as a result of contaminated products from a compounding pharmacy.
In the American Health Lawyers Association’s Weekly article, Rebecca discusses the Drug Quality and Security Act and ensuing Food and Drug Administration guidance documents. Rebecca also discusses the United States Pharmacopeia’s proposed revisions to its sterile compounding standards. A second set of proposed standards will be released for comment in July 2018.
To read the article, click here.
Rebecca Burke
Rebecca has more than 35 years of experience in health law. Her practice encompasses a broad range of regulatory, fraud and abuse, and reimbursement issues that affect physicians, hospitals, transplant centers, diagnostic testing facilities, and various other healthcare providers. She also advises clients on issues related to telemedicine and remote patient monitoring. She regularly helps clients advocate with the Centers for Medicare and Medicaid Services and other federal agencies on such matters as Medicare and Medicaid payment, coverage and coding.
For more information, please contact Rebecca Burke at Rebecca.Burke@PowersLaw.com or 202-872-6751.