Insights by

Martha Rumore

Of Counsel

Pharmacist-attorney and registered patent attorney with over two decades in FDA regulatory, DEA, Board of Pharmacy, and pharmaceutical intellectual property matters. One of the most published voices in U.S. pharmacy law.

Pharmacist and licensed attorney
Registered patent attorney
Author of 200+ publications in pharmacy law
503A and 503B compounding counsel (including GLP-1s and peptides)
FDA regulatory, DEA, and state Board of Pharmacy practice

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5 articles published

Articles by Martha

Compounding Pharmacy

Peptides: Legal and Regulatory Risks 503A Compounding Pharmacies Must Understand

FDA scrutiny of peptide compounding is intensifying, and 503A pharmacies are squarely in focus. If you compound, source, or dispen…

Mar 23, 2026

Compounding Pharmacy

FDA and Novo’s Uncharted Waters to Exert Pressure on Hims & Hers and GLP-1 Compounders

Novo’s lawsuit against Hims & Hers, coupled with FDA’s referral to the DOJ, marks a direct escalation against 503A compounded sema…

Feb 16, 2026

Compounding Pharmacy

What Wells Pharma v. Zyla Life Sciences Means for Compounding Pharmacies and Outsourcing Facilities

A pending Supreme Court case could reshape how compounding pharmacies face litigation under state unfair competition laws tied to…

Jan 26, 2026

Compounding Pharmacy

FDA Targets GLP-1 and Peptide Compounding, Advertising and ‘Research Use Only’ Labeling

FDA ramps up enforcement on GLP-1s, peptides, RUO labeling, and compounding practices. See how 503A and 503B facilities are affect…

Jan 8, 2026

Compounding Pharmacy

Darmerica - FDA Issues Warning Letter Targeting GLP-1 API Supply Chain Manufacturer

FDA issued a Warning Letter to Darmerica citing cGMP violations and improper distribution of GLP-1 and peptide APIs. Learn what th…

Jan 7, 2026