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

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 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.

Novo Nordisk, Inc. opposes the nomination of semaglutide to the 503B Bulks List, arguing that there is no established clinical need for compounded versions of the drug. The company contends that FDA-approved semaglutide medicines are safe and effective for various patients and that compounded products pose significant quality and safety risks, including potential immunogenicity from impurities.

BPI Labs, a laboratory entity, is requesting that the FDA add Semaglutide and Tirzepatide to the 503B Bulk Drug Substances List. They argue that including these substances will improve patient access to high-quality, quality-controlled compounded medications for metabolic disorders like Type 2 Diabetes and obesity.

Novo Nordisk Inc. opposes the nomination of semaglutide to the 503B Bulks List, arguing that there is no demonstrated clinical need for compounding since FDA-approved versions already exist. The company contends that compounded semaglutide poses significant safety risks, including sterility and potency issues, and that its inclusion would undermine the drug approval process.