APC’s Blueprint: What’s next is up to you

APC has taken a major step this week toward a more efficient, effective regulatory approach for compounding — one that preserves safety without undermining access or innovation.

We’ve released Pharmacy Compounding: A Blueprint for Eliminating Redundant, Unauthorized, or Ineffective Regulation that Impedes Patient Access to Compounded Drugs, a blueprint for the Trump administration (that’s been months in the making) that identifies outdated, unauthorized, or unscientific policies that need to be eliminated to benefit patients, compounding, and prescribers.

Congress and the administration must ensure FDA and DEA regulations are grounded in statute, supported by evidence, and respectful of prescriber and patient needs. This Blueprint shows them how.

Key recommendations include:

• Eliminating the obsolete 1997 FDA-State MOU requirement, which was rendered unnecessary by the Drug Quality and Security Act of 2013.
• Preventing FDA overreach on 503A “Demonstrably Difficult to Compound” rules, ensuring that only individual drug products, not entire categories, are restricted.
• Safeguarding access to compounded hormone therapies, which millions of patients rely on, especially women.
• Rejecting unbalanced FDA communications that conflate compounded medications with counterfeit or unsafe products.
• Accelerating completion of the 503B bulks list to support hospital and clinic access to essential compounded medications.
• Calling on DEA to clarify constructive transfer and anticipatory compounding policies, aligning enforcement with real-world clinical practice.

For the White House, the Blueprint is a collection of ideas that jibe with the administration’s focus on reducing regulation. For the compounding community it’s a call to action. It’s an opportunity to reduce the regulatory burden that too often stands between patients and the care they need. 

We need you to read it, and then we need you to act. APC’s Blueprint lays out the facts, but it’s not enough to write the message — we need you to put it in the hands of your elected officials. Share it with Republicans in Congress because they have the ability to change policies. When they hear it from their constituents, it matters. Your voice can shape decisions. Now is the time to use it.

Download it. Then write or call your legislators and send them a copy — even add a short explanation of how poorly considered regulation has affected your practice and your patients. You’re not just pointing out an issue, you’re also offering an administration-friendly solution!

Let's turn this blueprint into real change. Together, we'll make sure it resonates with the policymakers who have the power to make it happen.