Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

Ajenat Pharmaceuticals LLC is requesting that the FDA add Enclomiphene Citrate to the 503B Bulk Drug Substances List. They argue that the substance is a well-established therapeutic agent for hypogonadism and that its inclusion will improve patient access to high-quality, standardized compounded medications.

An individual who successfully lost weight using compounded tirzepatide argues that banning compounded versions of these medications would deprive many people of affordable access. They contend that because insurance does not cover the expensive brand-name drugs, compounded options are essential for managing obesity and preventing related chronic diseases.

A Director of Case Management at an acute care hospital argues that excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list could disrupt continuity of care for hospitalized patients facing commercial access barriers. They request that the FDA consider a limited, well-regulated allowance for compounded GLP-1 medications in specific clinical scenarios to prevent prolonged hospital stays and readmissions.

A patient who successfully used compounded GLP-1 medications to manage weight and health issues argues that the FDA's proposal to exclude these drugs from the 503B bulks list ignores real-world accessibility issues. They contend that because insurance often denies coverage for FDA-approved versions, compounded medications are a necessary and viable pathway to care for many patients.

An individual who uses compounded medication due to high costs and insurance denials expresses support for the action. They argue that expanding options for compounded drugs is necessary to improve quality of life and provide cost savings for patients facing a cost of living crisis.

The commenter, a patient with a systemic mast cell disease, supports the proposed action but advocates for its expansion to include inactive ingredients (excipients) on the list of bulk drug substances. They argue that including inactive ingredients is necessary to ensure patient safety, provide transparency, and account for the adverse reactions sensitive patients may experience.

A graduate student in health policy supports the FDA's proposed framework for establishing a public docket for bulk drug substances. The commenter argues that requiring evidence-based clinical justification for nominations ensures patient safety and health equity while maintaining access to necessary individualized care.

A registered nurse and future advanced practice registered nurse supports the FDA's process for identifying bulk drug substances for compounding. They argue that compounding pharmacies provide essential flexibility and access to medications, particularly during shortages, and urge the FDA to maintain transparent, evidence-based criteria for these listings.

Novo Nordisk Inc. opposes the Outsourcing Facilities Association's (OFA) nomination of semaglutide and other bulk drug substances to the 503B Bulks List. The company argues that mass compounding these substances poses significant safety risks to patients, lacks a legitimate clinical need, and undermines the FDA's drug approval process.

PhRMA, representing leading biopharmaceutical research companies, opposes the Outsourcing Facilities Association's (OFA) nomination of bulk drug substances for the 503B Bulks List. They argue that the OFA's "en bloc" nomination lacks specific evidence of clinical need, poses significant patient safety risks, and undermines the integrity of the FDA's drug approval process.