Bill would tighten FDA rules on compounded drug copies and inspections

What does this do?

The bill narrows the definition of an illegal "copy" of a commercial drug and limits pharmacies to 20 near-copies per month for a patient unless a documented medical difference exists. It adds annual FDA reporting for compounders exceeding that limit for out-of-state patients, mandates inspections for large outsourcing facilities before and every two years after making a new drug, removes a registration exemption, and lets the FDA set its own base registration fee instead of a fixed amount.

Who does it affect?

Affects compounding pharmacies, large-scale drug outsourcing facilities, and prescribing physicians; hospital pharmacies treating their own patients are exempt from the new reporting rule.

Why does it matter?

The changes give the FDA more oversight and data on large-scale production of drugs resembling existing commercial medications, which could affect how available certain customized medications are to patients.

Where does it stand?