📢 Missed the Webinar? Catch it On-Demand!
Webinar Title: DSCSA – 13 Year Implementation & 2024 Update
Accreditation: 1-hour CE (0.1 CEUs) for Pharmacists & Pharmacy Technicians
The DSCSA, enacted in 2013, is nearing full implementation! This on-demand webinar covers:
✅ Key DSCSA requirements for transaction information (TI) and transaction statements (TS)
✅ Steps to implement electronic traceability at the package level
✅ Strategies to ensure compliance with regulatory audits and inspections
✅ Best practices for identifying and reporting suspect products
FDA Enforcement Deadline: November 27, 2026 – Don’t wait to start preparing!
Speaker:
Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. She is also a registered patent attorney and leads the firm’s Intellectual property team. She has broad and in-depth healthcare and regulatory experience. Her practice focuses on intellectual property (patents, trademarks, copyrights, trade secrets) and healthcare law, Food, Drug, Device & Cosmetic law (all facets-483s to clinical trials to registrations and product approval), pharmacy law and regulatory issues, 503A/503B compounding, Board of Pharmacy (licensing and disciplinary matters), PBM audits, and DSCSA supply chain compliance. Dr. Rumore has over 25 years of health-system, pharmaceutical industry, and law firm experience in the area of Food, Drug & Cosmetic Law, and pharmaceutical intellectual property Dr. Rumore is fluent in cGMPs, GCPs, writing and reviewing Clinical Trial Agreements (CTAs), Investigator brochures, manuscripts, labeling & advertising review, NDAs, study reports, and documents for regulatory submissions. She often prepares legal memoranda on healthcare/FDA matters and conducts Mock State Board of Pharmacy and FDA inspections for compounding pharmacies. Dr. Rumore has practiced both pharmacy and law. She has actual experience as a compounding pharmacist. She regularly counsels on Section 503A and state-specific compounding requirements, assesses compounding practices for state and federal regulatory compliance, including USP 797/795/800, medical necessity documentation, advertising & promotion, reimbursement issues, infrastructure, and preparing compounding policies and procedures that provide clear guidelines, standards, and training for staff. Previously, she was at the Director level in Drug Regulatory Affairs/Compliance in the pharmaceutical industry and hospital pharmacy. She taught Pharmacy Law, Drug Regulatory Affairs, and Food Drug & Cosmetic Law at several New York Colleges of Pharmacy 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.
