About Dr. Rumore
Dr. Martha M. Rumore is a pharmacist and an attorney, admitted to the New York, New Jersey and District of Columbia bars, and Of Counsel at Health Law Alliance, where she heads the FDA/Compounding Group. She holds a Pharm.D. from St. John’s University, an M.S. in Medical Communications and Drug Information from Long Island University, a J.D. from CUNY School of Law, and an LLM in Intellectual Property from the Benjamin N. Cardozo School of Law.
Her practice focuses on FDA and healthcare regulatory services and intellectual property, built on 20 years of law firm experience in food, drug and cosmetic law and pharmaceutical compounding. She regularly advises on 503A and 503B compounding — particularly GLP-1s and peptides — along with Drug Quality and Security Act compliance, Board of Pharmacy and DEA regulation of pharmacy, API importation, compounding labeling and advertising review, recalls, clinical trial management and cGCPs, 510(k) and PMA submissions, investigational drug labeling, adverse-event reporting and medication safety.
Before practicing law she worked at director level in drug regulatory affairs in both the pharmaceutical industry and hospital pharmacy, and directed the clinical research department of Glenbrook Laboratories/Sterling Drug as Associate Director, Medical Affairs. She has taught drug regulatory affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy, and currently teaches Food, Drug & Cosmetic Law at the Maurice A. Deane School of Law at Hofstra University.
A frequent lecturer on 503A compounding and DSCSA, Dr. Rumore has more than 200 publications and presentations. She is a Fellow and former Trustee of the American Pharmacists Association, a former board member of the American Society for Pharmacy Law and of the Accreditation Council for Pharmacy Education, and a three-time recipient of the Larry Simonsmeier Legal Writing Award. As a former compounding pharmacist herself, she brings a practitioner’s view to FDA and Board of Pharmacy compliance for 503A compounding and 503B outsourcing facilities, and advocates for pharmacists and pharmacies.
Credentials & expertise
What Dr. Rumore teaches at Empire
Dr. Rumore teaches Module 12 of Empire’s Peptide Therapy Certification — the legal and regulatory layer that clinical peptide training usually leaves out. It is the part of the program that answers where a given peptide actually stands before a regulator asks, rather than after.
- 01Prescribing & Compounding Law — FDA compounding rules for 503A and 503B pharmacies, bulk-substance category status, patient-specific prescriptions versus office use, repackaging and relabeling, and the product categories a peptide can fall into: drug, cosmetic, dietary supplement or biologic.
- 02Legal Structure, CPOM & Insurance — how the practice is owned and structured, corporate practice of medicine, and the cover that has to sit behind it.
- 03EMR, Consent & Intake Templates — the documentation that makes a protocol defensible.
- 04Telehealth & Multi-State Practice — practising across state lines, and what a white-label telehealth partner does and does not shield you from.
- 05Staff Training, Delegation & Medical Direction — scope of practice, supervision, and how a sales force is paid without creating an anti-kickback problem.
Train with Empire Medical Training
Learn peptide therapy the way it has to be practised — the clinical protocols and the law that governs them, taught together. CME-accredited, in person or by livestream.
See the Full Curriculum → Meet the Faculty