SAFE Drugs Act of 2025

Summary#

This bill changes parts of the Federal Food, Drug, and Cosmetic Act that deal with compounding pharmacies and outsourcing facilities. It limits how often a pharmacy can compound a drug that is essentially a copy of a commercial drug (no more than 20 times in a single month). It defines what "essentially a copy of a commercially available drug product" means. The bill creates an annual reporting requirement starting in calendar year 2025 for pharmacies, facilities, and physicians that compound such products more than 20 times in a month for patients who live outside the State where the compounding occurs. Hospital pharmacies compounding for hospital patients are excluded from that reporting rule. The bill sets inspection rules for "large-scale" outsourcing facilities (defined as compounding more than 100 times in a calendar year): an inspection before the facility compounds a drug for the first time and reinspections at least every two years. It removes an exemption in one registration provision so that outsourcing facilities are treated differently under that section. Those inspection and registration changes take effect 6 months after enactment. The bill also replaces a specified $15,000 base establishment fee amount with a base amount the Secretary will set to fund safety activities for compounded drug products.

What it means for you#

• If you run a retail compounding pharmacy or are a physician who compounds drugs: you must file an annual report (starting with calendar year 2025) if you compound more than 20 times in a month for patients who live out of state. The report must list each type of such product and how many times it was compounded each month. Hospital pharmacies compounding for hospital patients do not have to file this report.
• If you run or plan to run an outsourcing facility: facilities that compound more than 100 times in a year are defined as "large-scale" and must be inspected before first compounding and at least every two years afterward. An exemption in a registration provision is removed so outsourcing facilities may have different registration requirements.
• If you are a patient: the bill changes how often and where certain compounded copies of commercial drugs can be made and creates new reporting and inspection steps for providers who compound frequently.
• If you are a manufacturer or distributor of commercially available drugs: the bill clarifies when a compounded product is considered an "essentially a copy" of a commercial product by looking at active ingredients and whether a patient-specific change produces a significant difference as determined by the prescribing practitioner.

Expenses#

The bill replaces a specified $15,000 base fee with a base amount to be set by the Secretary to fund safety activities for compounded drug products, but it does not set a dollar amount in the text. No publicly available information on overall budgetary or cost estimates is provided in the bill text or metadata.

Proponents' View#

No publicly available information.

Opponents' View#

No publicly available information.