Introducing HR 5316

A huge thanks to Rep. Diana Harshbarger for introducing HR 5316 — “The Drug Shortage Compounding Patient Access Act of 2025” — to Congress*. It’s all about clear and common-sense ways to protect patients’ access to essential medications during a drug shortage.

Here’s our one-page brief on what it does, and here’s a brief on the brief: HR 5316 would strengthen the drug supply chain by requiring more transparency from drugmakers, and it would modernize some of the outdated provisions of the Food, Drug, and Cosmetic Act to clarify FDA’s authority (and codify the priority of prescriber judgement). The bottom line, though, is that it would ensure that both 503A state-licensed pharmacies and 503B outsourcing facilities can meet essential patient needs while maintaining rigorous safety standards.

Slowly turn the wheels of government, so as of this writing the text of the bill isn’t online yet, but it soon will be on Congress.gov. 

Once the bill is live on Congress’s website, we’ll turn our lobbying up to 11 — and we’ll need your help reaching out to every member of Congress to have them sign on and support HR 5316. Stay tuned.

* Its official title is “To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes.”