Patient-safety concerns that have emerged in the GLP-1 era deserve real answers. APC has developed five targeted policy proposals that address identifiable risks without unnecessarily restricting lawful pharmacy compounding, prescriber judgment or patient access.

Despite a name suggesting legislation aimed at fraudulent drugs, the so-called “SAFE Drugs Act” regulates legitimate pharmacies and outsourcing facilities already operating within rigorous federal and state regulatory systems. The Senate has substantially improved its bill. The House has not.

About 1.5 million Americans rely on animal-derived thyroid medications, including patients for whom synthetic thyroid medications have not adequately addressed their needs. FDA’s decision to classify these products as biologics threatens continued access to patient-specific compounded DTE. Congress and FDA can help correct that result.

Some peptides patients are seeking today cannot legally be compounded by pharmacies. Yet demand has not disappeared. Consumers can readily obtain “research use only” or improperly sourced products outside the regulated healthcare system. APC believes FDA should consider a carefully controlled pathway for appropriate peptides that brings patients and ingredients into a regulated healthcare framework.