S3794-119

What This Bill Does

The reported SAFE Drugs Act replaces the introduced bill's copy-product limits, large-outsourcing-facility inspection schedule, and discretionary establishment-fee provision with a narrower reporting-and-labeling framework. A pharmacist or physician compounding under section 503A who sends a product outside the compounding State must forward every received serious-adverse-event report to FDA, the compounding State, and every destination State. Starting with the first full calendar year after enactment, an interstate compounder sending more than 5 percent of annual compounded output out of State must report its identity and license information and monthly units by product type to FDA and destination States by January 15. FDA must support information sharing to reduce duplicative reporting. On-premises hospital pharmacies serving hospital patients are excluded, and States may retain stricter or supplemental reporting rules. Compounded-drug labels must state that the medication is compounded for an individual patient and is not FDA approved, provide the MedWatch website and telephone number, and carry any additional information FDA orders.

Who Benefits and How

Patients receiving compounded drugs gain clearer notice that the products are not FDA approved and a direct route for reporting adverse events. FDA and state pharmacy and health authorities gain serious-event reports and annual interstate-volume data that can support safety surveillance and enforcement. Destination States gain visibility into products entering their jurisdictions, while the information-sharing system can reduce duplicate submissions. Hospital pharmacies compounding only on premises for hospital patients avoid the new interstate reporting duties, and States preserve authority to impose stronger requirements.

Who Bears the Burden and How

Licensed pharmacists and physicians who send section 503A compounded products across state lines must track adverse-event information and, above the 5-percent threshold, compile annual identity, licensing, product-type, and monthly-unit reports. Compounders must also redesign labels and comply with later FDA-ordered disclosures. FDA and state agencies must receive, protect, share, and use the submitted information. Compared with the introduced text, pharmacies making copy-like drugs and large outsourcing facilities avoid the proposed monthly copy cap, mandatory biennial inspection rule, registration change, and Secretary-set establishment fee because those provisions are not retained in the reported substitute.

Key Provisions

• Requires interstate section 503A compounders to forward received serious-adverse-event reports to FDA and affected States.
• Requires annual interstate dispensing reports from compounders whose out-of-state volume exceeds 5 percent.
• Creates an FDA-supported information-sharing process to reduce duplicative reporting burdens.
• Provides an exclusion for qualifying on-premises hospital pharmacies and protects stricter state requirements.
• Requires compounded-drug labels to disclose nonapproval and list FDA MedWatch contact information.
• Repeals the introduced approach by omitting its copy cap, outsourcing-facility inspection schedule, registration change, and fee provision from the reported substitute.