Martha Rumore
Articles by Martha
Peptides & 503A Compounders: FDA PCAC Meeting and Beyond
A PCAC meeting with close to 2000 comments on the public docket and a recommendation that goes against FDA staff recommendations!…
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…
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…
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…
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…
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…