Constitutional Opinion No. 2026-0670
Case Information
- Content Scored
- H.R. 6509 (119th) — SAFE Drugs Act of 2025 (drug-compounding regulation / FDA oversight)
- Source
- U.S. Congress (govinfo.gov)
- Author
- Reps. Yakym and Carson
- Publication Date
- 2025-01-01
- Content Type
- Legislation
- Opinion Issued
- 2026-07-19
- AFCS Version
- 1.0
Holding
H.R. 6509 amends the Federal Food, Drug, and Cosmetic Act to tighten regulation of drug compounding: Section 2 restricts pharmacies from compounding drugs "essentially a copy of a commercially available drug product" to no more than 20 times monthly; Section 3 adds annual reporting for large out-of-state compounders; Section 4 requires pre-compounding inspections and biennial reinspections of large-scale outsourcing facilities and removes their registration exemption; Section 5 replaces the fixed $15,000 base establishment fee with a Secretary-set base amount. As operative statutory text scored for the policy it enacts, it takes the v1.2 Legal/Normative Text Weighting (85/15). The bill is genuinely mixed: its purpose — safeguarding Americans from fraudulent/experimental compounded drugs — aligns with the safety-of-the-citizen commitment (Article XVIII, scored 62), but its mechanism is federal regulatory expansion (new FDA inspections, reporting mandates, restrictions on compounding enterprise, delegated fee-setting), cutting against Federalism (XII, 42) and mildly Property and Enterprise (IX, 45). The Court notes but does not score a populist access/affordability counter-current (no such article exists in the canon). Tier 1 = 50; under 85/15 the substance governs and the result is 56 — Mixed. Facility fees are not a new tax on Americans, so no Automatic Fail. (Default 70/30 would have returned 61.)
It is the judgment of this Court that Opinion No. 2026-0670 is hereby entered into the record, in accordance with the America First Constitutional Standard. The score stands. The reasoning is published. The record is public.