Akin Gump Hosts 503B Compounding Webinar Panel

Akin Gump health care and life sciences partner Nathan Brown moderated a webinar panel, hosted by the firm on October 1, titled Looking Ahead: A Forum on 503B Compounding. The event was intended for facilities that have registered as drug outsourcers under Section 503B of the Drug Quality and Security Act of 2013.

This forum served as an opportunity for newly registered outsourcing facilities to hear from leading policy voices on pharmacy compounding and to engage in a dialogue about some of the regulatory issues and challenges facing the industry. Panelists included representatives of The Pew Charitable Trusts, the Working Group on Pharmaceutical Safety and the American Society of Health-System Pharmacists.

Among the topics discussed were:

  • how the emergence of the 503B sector has provided hospitals and other health care providers a safe and reliable source of compounded sterile preparations
  • challenges relating to the U.S. Food and Drug Administration’s (FDA’s) oversight actions and unfinished implementation
  • states’ reactions to the new federal law and application of state requirements to outsourcing facilities.

Prior to joining Akin Gump, Mr. Brown previously served in the chief counsel’s office at FDA and as an advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee.