Equip yourself with essential knowledge about the management and distribution of 503A compounded products, the intellectual property intricacies in peptide and semaglutide compounding, and understanding the FDCA and recent FDA guidance. Moreover, you will be able to assess the regulatory landscape effectively, ensuring your practices are in line with state laws and regulations.
Activity Description:
As the landscape of compounding peptides and semaglutide continues to evolve rapidly, a multitude of legal challenges and opportunities arise. This session aims to shed light on the pivotal developments and regulatory nuances in this dynamic sector. Our speakers will delve into critical topics such as the FDA’s current stance on peptide compounding, recent pronouncements from state Boards of Pharmacy, and the intricate legalities surrounding brand manufacturers. Additionally, the webinar will explore the burgeoning realm of telemedicine and its implications for compounders, along with guidance on navigating the complexities of bulk chemical ingredients.
At the completion of this activity, the participant will be able to:
- Discuss the management and distribution of 503A compounded products among DSCSA trading partners,
encompassing transfers, dispensing, and oversight by state Boards of Pharmacy, particularly focusing on
semaglutide and peptide compounding. - Evaluate the intricacies of intellectual property in peptide and semaglutide compounding and advertising.
- Analyze the key aspects of the FDCA and recent FDA guidance on compounding peptides and semaglutide,
including the legal trends involving compound semaglutide, manufacturer enforcement efforts, and the impact
on telemedicine arrangements. - Assess the regulatory landscape by comparing state laws concerning pharmacies’ compensation and feesharing
with prescribing physicians, within the context of compounded semaglutide and telemedicine practices.
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.
Speakers:
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.
Matthew J. Modafferi, Esq is a seasoned litigation and trial attorney with experience in healthcare law. He focuses his practice on white collar defense and investigations, and complex civil litigation. As a Partner in Frier Levitt’s Healthcare and Life Sciences Litigation Department, Matthew’s practice is dedicated to representing healthcare clients in litigation matters including healthcare fraud, qui tam, and False Claims Act matters. Matthew also helps clients successfully navigate DEA inspections and investigations, state and federal OIG investigations, and government self-disclosures. Matthew previously worked as an Assistant United States Attorney in the Civil Division at the U.S. Attorney’s Office for the Eastern District of New York. During his time as a federal prosecutor, Matthew represented the United States and its agencies in various affirmative and defensive matters, appearing before both the Eastern District of New York and the Second Circuit Court of Appeals. He successfully defended Executive Branch policies and initiatives, and prosecuted health care fraud qui tam and other False Claims Act cases.
