Regulatory Considerations in Compounding Pharmacy Practice with Martha Rumore

In this episode, Our guest, Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.

Dr. Rumore has also worked in Drug Regulatory Affairs in the pharmaceutical industry and hospital pharmacy, both at the Director level. She taught Pharmacy Law and Drug Regulatory Affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy for close to 20 years and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University.

She is a frequent lecturer and has over 200 publications and presentations. Additionally, Dr. Rumore is a Fellow and former Trustee of the American Pharmacists Association, a former Board member of the American Society for Pharmacy Law and the Accreditation Council for Pharmacy Education and is a three-time recipient of the Larry Simonsmeier Legal Writing Award.

This in-depth discussion on the current regulatory landscape for compounding pharmacies will look at:

• Current Regulatory Environment for 503A and 503B Compounding
• State Laws and State Board of Pharmacy 2023/2024
• Important Regulatory Considerations in the 503B to 503A Compounding Model for Community Pharmacies
• 506e Shortages and Beyond
• USP 797/795 Six Months Later

Guest - Martha Rumore Senior Counsel

[email protected]

646.970.3226

Host - Hillary Blackburn, PharmD, MBA

www.hillaryblackburn.com

• https://www.linkedin.com/in/hillary-blackburn-67a92421/
• @talktoyourpharmacist for Instagram and Facebook

@HillBlackburn Twitter