Date and Time of Activity
Tuesday, October 1, 2024
11 am EDT/ 10 am CDT/ 9 am MDT/ 8 am PDT
Pharmacy professionals play a crucial role in protecting patient from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Enacted in 2013, DSCSA is taking over 13 years to implement. Pharmacies need to prepare for the DSCSA requirements with a November 27, 2026 FDA enforcement implementation to receive or exchange transaction information electronically and conduct package level verification. The implementation of systems to produce serialized transaction information in a readily retrievable manner and develop SOPs for regulatory or trading partner transaction data requests will take time, and pharmacies should start today, if they have not already, to ensure compliance with the new enforcement implementation date. That said, despite the DSCSCA granting an exemption for small dispensers until November 27, 2026, pharmacies should be aware of their obligations to make appropriate purchases and maintain inventory purchase information in accordance with their Pharmacy Benefit Manager (“PBM”) Provider Manuals and Agreements. PBMs continue to audit pharmacies to ensure their sourcing of inventory is valid and despite any exemption granted by the DSCSA, such audit measures are expected to continue.
Activity Description:
In this webinar, we will review the phased in implementation and provide update of 2024 and beyond.
At the completion of this activity, the participant will be able to:
- Identify the DSCSA requirements for receiving, validating, and storing DSCSA Transaction Information (TI) and Transaction Statements (TS).
- Describe the procedures for implementing electronic operability at the package level for traceability.
- Identify the regulatory requirements and documentation needed for compliance with audit records, inspections, and other inquiries.
- Explain the processes for verifying product legitimacy, including methods for quarantining, investigating, and reporting suspect products.
The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.
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.
