FDA Issues New Draft Documents Related to Compounding of Human Drugs - FDA Call at 2 pm Eastern
Friday, February 13, 2015
Posted by: Dagmar Anderson
Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging "that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians."
From the FDA news release, "The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule."
IACP is reviewing these documents now, and will be creating a summary for our Members. Please click here to read more.
IACP Members - There is an FDA call today, providing an overview of the four draft guidances. Please see call-in information below.
The call will be today, Friday, February 13, 2015 at 2:00 p.m. ET. The call-in number is 1-888-989-4391. The passcode for all callers is “FDA.”
Jane Axelrad, Associate Director for Policy in FDA’s Center for Drug Evaluation and Research (CDER) and Agency Lead on Compounding, will provide an overview of the four draft guidances, which are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians. She will also discuss the fifth document, the draft memorandum of understanding, which addresses interstate distribution of compounded drug products under section 503A of the Food, Drug, and Cosmetic Act.
A Question and Answer Session will follow the speaker’s presentation. Anna Fine with the FDA Office of Health and Constituent Affairs will moderate the call.
A replay of the briefing will be available one hour after the call ends until March 13, 2015. To hear the replay callers in the United States and Canada can dial 800-947-5189.