Overview
Late last year, FDA released a revised draft guidance entitled “Compounding Animal Drugs from Bulk Drug Substances” that outlines circumstances under which the agency will exercise enforcement discretion for compounding of animal drugs from bulk substances where no other medically appropriate treatment exists. The guidance addresses compounding of patient-specific prescriptions for non-food producing animals; compounding of “office stock” from bulk drug substances for non-food producing animals; and compounding of antidotes for food-producing animals. Speakers will address FDA’s goals for animal drug compounding under the guidance and how it differs from compounding of human drugs, industry reaction to the guidance, and specific industry concerns such as the requirement to start from an FDA-approved drug rather than an API and the criteria for office use. The deadline to submit comments to FDA on the draft guidance is June 17, 2020.
Get Access
- +$100 for nonmembers
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Speakers
Matt Martin, Clinical Services Manager, Professional Compounding Centers of America (PCCA)
Rachael Pontikes, Partner, Reed Smith LLP and Chair, DQSA – Updates in Compounding Conference
Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
MATT MARTIN joined the Professional Compounding Centers of America (PCCA) Pharmacy Consulting team in September 2015. He graduated from Morehead State University with a BS in Chemistry in 2002 and received his PharmD from the University of Kentucky College of Pharmacy in 2006. Prior to joining the PCCA team, Matt worked in a compounding pharmacy for more than eight years and has experience with both sterile and non-sterile preparations.
RACHAEL PONTIKES is a partner in the Life Sciences Health Industry Group and practices in the Chicago office of Reed Smith. Rachael acts as litigation counsel for compounding pharmacies, outsourcing facilities, and other health care entities in disputes with the state boards of pharmacy, FDA and DEA in administrative proceedings and federal courts. She also counsels health care entities involved in compounding, in both human and animal health, regarding compliance with various applicable state and federal law as well as leading the health care aspects of corporate transactions. Rachael is a nationally recognized authority in the DQSA Compounding Quality Act (CQA), and participated in various discussions with the Senate HELP Committee staffers as the law was drafted. She is frequently invited to speak on the DQSA-CQA and its implications for health care entities that compound.
STEVEN M. SOLOMON was appointed Center Director of the Food and Drug Administration’s Center for Veterinary Medicine in January 2017. Dr. Solomon previously served as the Deputy Associate Commissioner for Regulatory Affairs within the Food and Drug Administration’s Office of Regulatory Affairs. He joined FDA in 1990 as a Veterinary Medical Officer in the Center for Veterinary Medicine and has served in various policy and leadership positions in the Office of Regulatory Affairs’ Office of Enforcement, Office of Regional Operations, and as the Assistant Commissioner for Compliance Policy. He also served in the Office of Global Regulatory Operations and Policy. Dr. Solomon has a Doctor of Veterinary Medicine from Ohio State University and a Master’s in Public Health from Johns Hopkins University.Virtual Learning FAQ
Related Content
