Frequently Asked Questions
Why is an Ozempic compliance program necessary?
Healthcare is a highly regulated industry, and an effective compliance program helps to reduce the risk of regulatory noncompliance.
What are the elements of an Ozempic compliance program?
Compliance programs typically include seven elements, including written policies and procedures; employee training and education; monitoring; and remedial action.
Who is responsible for administering an Ozempic compliance program?
Depending on the size of the business, compliance oversight may be performed by a designed Chief Compliance Officer, Compliance Committee, or Board of Directors. In smaller businesses, a Compliance Manager or Business Lead may perform the function.
Short Hills, NJ - Health Law Alliance is pleased to announce that Dr. Martha M. Rumore, a nationally recognized pharmacist-attorney and registered patent attorney, has joined the firm as Of Counsel. With over two decades of experience in FDA, DEA, Board of Pharmacy, and pharmaceutical intellectual property matters, Dr. Rumore brings exceptional depth to the firm’s healthcare and regulatory practice.
Dr. Rumore holds a Pharm.D. from St. John’s University, a J.D. from CUNY School of Law, a Master’s in Medical Communications and Drug Information from Long Island University, and an LLM in Intellectual Property from Benjamin N. Cardozo School of Law.
She is admitted to the New York, New Jersey, and D.C. bars, and is a Fellow of the American Pharmacists Association.
For the past six years, Dr. Rumore served as Senior Counsel at Frier Levitt in Manhattan, where she focused on FDA regulatory, DEA enforcement, Board of Pharmacy compliance, and pharmaceutical IP matters. Her expertise includes 503A and 503B compounding (including GLP-1s and peptides), DSCSA compliance, recalls, clinical trial management, labeling and advertising review, and submissions ranging from 510(k) to PMA applications.
Dr. Rumore has also held leadership positions in industry, including as Associate Director of Medical Affairs at Glenbrook Laboratories/Sterling Drug. She has taught Drug Regulatory Affairs and Food, Drug & Cosmetic Law at multiple institutions, including Hofstra University’s Maurice A. Deane School of Law. With over 200 publications and presentations, she is a frequent national lecturer on FDA and pharmacy law topics.
“Martha is a powerhouse addition to our team,” said Health Law Alliance founder Anthony Mahajan. “Her unique combination of pharmacy practice, legal expertise, and regulatory insight further strengthens our ability to defend pharmacies, providers, and healthcare organizations nationwide.”
To contact Dr. Martha Rumore, please call 800-345-4125 or fill out the form on this page.
Read more about Health Law Alliance's compounding pharmacy services here.
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