Dr. Martha Rumore is a nationally recognized pharmacist-attorney and registered patent attorney with over two decades in FDA regulatory, DEA, Board of Pharmacy, and pharmaceutical IP matters, and one of the most published voices in U.S. pharmacy law.
Pharmacy law sits at an unusually dense intersection of federal regulatory frameworks - the Federal Food, Drug, and Cosmetic Act, the Drug Quality and Security Act (DQSA), the Controlled Substances Act, state pharmacy practice acts, and the federal patent and exclusivity regime. Practitioners who can speak fluently across all of those frameworks are rare. Martha is one of them.
Martha advises on 503A and 503B compounding - particularly GLP-1s and peptides - and DQSA compliance. The 503A pharmacy and 503B outsourcing-facility framework has become one of the most enforcement-active corners of FDA's jurisdiction over the last several years, with FDA inspection findings and warning letters driving the regulatory cycle. Martha's practice covers the full lifecycle: pre-inspection readiness, on-site inspection response, FDA Form 483 reply, warning-letter response, and remediation work. Compounding clients facing FDA scrutiny on GLP-1 or peptide preparations rely on her for the regulatory framework expertise that the moment requires.
Martha's broader FDA practice spans the full spectrum of FDA matters from API importation to medication safety. That covers active pharmaceutical ingredient (API) sourcing and import compliance, FDA establishment registration and listing, current Good Manufacturing Practice (cGMP) compliance, label and labeling matters, drug-product approval pathways, post-marketing pharmacovigilance, and adverse-event reporting. The FDA enforcement universe stretches from Warning Letters through consent decrees through criminal Federal Food, Drug, and Cosmetic Act prosecutions; Martha's work covers the full spectrum.
Martha's DEA practice covers controlled substance registration, schedule classification, recordkeeping, and diversion-investigation response. Her Board of Pharmacy practice covers state-level pharmacy practice act issues - the daily practice framework that governs how pharmacies actually operate, including state inspection regimes, disciplinary proceedings, and license defense.
As a registered patent attorney, Martha also advises on pharmaceutical intellectual property matters - patent prosecution, freedom-to-operate analysis, and the IP-regulatory interface that governs branded and generic drug competition. The dual qualification across FDA regulatory and patent law is one of the rarer credential combinations in the pharmaceutical bar.
Martha currently teaches Food, Drug & Cosmetic Law at Hofstra University's Maurice A. Deane School of Law. She has authored more than 200 publications and presentations in FDA, DEA, and pharmacy law, and is a three-time recipient of the Larry Simonsmeier Legal Writing Award. She is a Fellow of the American Pharmacists Association, the profession's senior recognition.
At Health Law Alliance, Martha's pharmacist-attorney credentials and FDA regulatory practice complement the firm's defense-side litigation, federal-prosecutor, and senior-healthcare-executive bench. She takes a leading role on FDA, DEA, Board of Pharmacy, and 503A/503B compounding matters across the firm's pharmacy and pharmaceutical-supply-chain client base.
Matters Martha personally leads - drawing on her dual pharmacist-attorney credential, registered patent attorney status, and 200+ publications across FDA, DEA, and pharmacy law.
Consultations are confidential and protected by attorney-client privilege. Our team responds within one business day - often sooner when time is of the essence.
