The Case for Reform

Stronger policy action can protect patients and restore integrity to the U.S. pharmaceutical supply chain, ensuring that every individual has access to safe and effective medicines.

Policy Pillars

ASEM is purpose-built and solutions-oriented, focusing on three key tenets:

Prescription bottles and medication packaging

Combating Counterfeit Drugs and Illegal Mass Compounding

The Problem

Mass-compounded products are being sold without the safeguards that make medicines trustworthy. Patients have no way of knowing what is in their product, or whether it is medicine at all.

The Solution

ASEM supports stronger FDA enforcement against mass compounders operating outside federal compounding law and clearer rules for the telehealth platforms and distribution channels that bring these products to market.

Pharmaceutical manufacturing equipment

Strengthening the Integrity of the U.S. Pharmaceutical Supply Chain to Fight Counterfeit Drugs

The Problem

The U.S. pharmaceutical supply chain is built on verified standards, accountable sources, and rules that apply to every medicine reaching patients. Bad actors undermine that guarantee.

The Solution

ASEM supports stronger ingredient oversight, supplier vetting, import accountability, and manufacturing standards for every product that reaches patients.

Medication vial and syringe

Holding Mass Compounders and Platforms Accountable

The Problem

Patients are being targeted with misleading claims, unclear sourcing, and products that can blur the line between legitimate pharmacy practice and mass compounding.

The Solution

ASEM supports transparency and accountability for mass compounders, advertisers, prescribers, and platforms whose products and claims affect patient safety.