Healthcare (Hospitals)

HR 6509, the SAFE Drugs Act of 2025, limits how often pharmacies and healthcare providers can create custom drug formulations that copy standard medications. It restricts compounding any drug essentially identical to a commercially available product to no more than 20 times per month for individual patients. The bill also requires pharmacies compounding such drugs for out-of-state patients more than 20 times monthly to report details to the FDA, while exempting hospital pharmacies. These changes aim to improve safety oversight of non-standard drug compounding by setting clear limits and reporting rules.

The SAFE Drugs Act of 2026 restricts pharmacies, facilities, and physicians from compounding more than 20 times in a single month for out-of-state patients any drug that is essentially a copy of a commercially available product (e.g., containing the same active ingredient without a significant patient-specific difference). It requires these providers to submit annual reports to the federal government detailing the types of drugs compounded and the frequency for such out-of-state compounding, with reports due by year-end. The bill also mandates initial and biennial inspections for large-scale compounding facilities (those compounding over 100 times yearly) and adjusts the base fee for compounding registration to be set by the Secretary. Hospital pharmacies are exempt from the reporting requirement.

This bill denies tax deductions to employers for expenses related to two specific services: (1) reimbursing employees for travel to obtain an abortion, and (2) covering gender transition procedures for a minor child (under age 18). It directly affects employers who provide health benefits or reimbursements for these services, making such costs non-deductible for tax purposes. Key provisions define "gender transition procedure" broadly to include medical/surgical services, puberty-blocking drugs, and cross-sex hormones, with limited exceptions for medically verified disorders of sex development or complications from prior procedures. The law would take effect for taxable years after enactment.