Lee Rosebush Comments on Delay in GMP Regulations for Drug Compounders

News / May 14, 2018

Partner Lee Rosebush is quoted in an article published by Inside Health Policy on May 14, 2018. The article, “FDA Announces Plans for New Tobacco Rules; Delays Compounding, OTC Rules,” discusses the Food and Drug Administration’s (FDA) recently announced spring 2018 regulatory agenda, which delays until October 2019 the agency regulation on good manufacturing practice (GMP) standards for 503B drug compounders.

Rosebush, who is chairman of the Outsourcing Facilities Association, is quoted as saying, “Even though you may have enforcement discretion from the agency, without those types of regulations - which is what we as an association are begging for . . . it's hard for us to be able to move forward.”

Read the article (registration required).