The U.S. House Introduces Bill to Expand Compounding During Drug Shortages, Provide Clarity on Bulk Substance “USP/NF Monograph” Definition, and Get Rid of Section 503A’s Tortured MOU Provision

On September 11, 2025, Reps. Diana Harshbarger (R-TN) and Buddy Carter (R-GA)—the only two pharmacists in the U.S. House of Representatives—introduced a new bill, titled “Drug Shortage Compounding Patient Access Act” (H.R. 5316), that would expand the ability of compounding pharmacies and outsourcing facilities to compound products during a drug shortage, while also providing these entities with a greater sense of regulatory certainty while trying to serve patients when the FDA-approved supply chain fails.

What Does the Bill Say?

The legislation would codify FDA policies—similar to the temporary policies implemented during the COVID-19 pandemic—that allowed compounding of medications for urgent hospital needs during particular shortage situations.  Specifically, it would:

• Authorize Section 503A pharmacy compounding during shortages:  Allow state-licensed 503A compounding pharmacies to compound FDA-approved drugs that, among other requirements, are on the shortage list for urgent hospital or clinical use when the hospital or clinic has documented that it is not able to procure the drug from the manufacturer or a Section 503B outsourcing facility.  FDA similarly permitted this Section 503A “office use” compounding for hospitals and clinics during the COVID-19 pandemic and also expanded Section 503B outsourcing facilities’ ability to compound COVID-19 medications in short supply.  See our April 2020 blog posts discussing these temporary FDA policies here and here.
• Provide transition periods:  Require a 60-day transition period for Section 503A pharmacies and a 180-day transition period for Section 503B outsourcing facilities to carry on compounding medications once a shortage has been declared resolved.  This appropriately permits compounders to diminish their supplies of API and finished products after the resolution of the shortage.
• Update compounding lists:  Require FDA to annually update the list of 503B bulk drug substances that can be used in compounding, thereby providing further clarity and regulatory certainty for Section 503B outsourcing facilities in more quickly defining what these facilities can—and cannot—compound.
• Improve drug shortage reporting:  Mandate that FDA-approved drug manufacturers report anticipated supply disruptions, including, for the first time, anticipated surges in demand, and that FDA consider “real-world data” from hospitals and patients when designating shortages.
• Provide clarity around monographed dietary supplements:  Allow compounders to use USP/NF monograph dietary supplements in their compounded drug products.  Notwithstanding Section 503A’s use of the term “USP/NF monograph” when addressing what bulk substances may be used in compounding, FDA has limited that term in its non-binding guidance document to mean compounders can only compound USP/NF monograph substances that are the subject of a “drug” and not a “dietary supplement” monograph.  Specifically, FDA historically has stated that FDA interprets “an applicable USP or NF monograph” to mean an official USP or NF drug substance monograph.  “Accordingly, FDA does not consider USP monographs for dietary supplements to be applicable USP or NF monographs within the meaning of section 503A(b)(1)(A)(i)(I).”  FDA, Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act at 3 (2025).
• Modernize outdated statutory terms:  Eliminate the decades old, contentiously litigated (to the compounders’ success), and much maligned interstate distribution Memorandum of Understanding requirement and related provisions in Section 503B(b)(3)(B).

Why It Matters

Drug shortages remain a persistent and growing challenge in the U.S. healthcare system, affecting treatments from cancer therapies to commonly used injectables.  Compounding pharmacies and outsourcing facilities have long acted as a critically needed safety net that provides patients access to lifesaving medications—both during the pandemic and, most recently, in the aftermath of the 2024 Western North Carolina floods.

Hurdles Ahead

Despite broad support from pharmacists and patient advocates, the bill likely will face resistance from brand name drug manufacturers, who often push to limit compounding once FDA declares a shortage resolved.  Legal disputes over compounded versions of high-demand and ubiquitously prescribed drugs, such as semaglutide and tirzepatide, highlight the ongoing tension between ensuring needed access to medications and addressing alleged safety concerns.

However, with shortages continuing to disrupt patient care and bipartisan interest in strengthening the pharmaceutical supply chain, the bill could gain important traction as part of broader efforts to bolster domestic drug availability.