TB-500

Federal history

• Jul 23, 2026PCAC reviewFederalreported

  PCAC under-review tag recorded

  MedSpaRadar qualification: FDA is not bound by PCAC recommendations. A reported recommendation does not establish current compounding eligibility. Category 1 nomination and FDA’s conditional interim enforcement policy are distinct from final 503A Bulks List rulemaking. The former explanation incorrectly tied Category 1 placement to rulemaking and supplied an unsupported 8–12 month estimate; it has been superseded. Assess the exact substance, form, route and all applicable conditions; no individual eligibility determination is made here.

  Superseded editorial explanation — archival evidence only

  Superseded editorial explanation, retained as historical evidence only. Its original author is not established; MSR analysis marks our qualification and archival presentation, not verified authorship. This is not an FDA quotation or current guidance. Recommendation, staff-position and vote-tally claims remain reported; primary verification is not established here.

  Under PCAC review — not yet compoundable. On Jul 23, 2026 the Pharmacy Compounding Advisory Committee recommended adding TB-500 to the FDA 503A Bulks List, 8–6–1 (FDA meeting minutes pending; FDA staff had recommended against). A recommendation is not a legal change — FDA is not bound, and 503A compounding would require Category 1 placement via notice-and-comment rulemaking (commonly 8–12 months).

  Original text SHA256: da4091be12c4065930023f6b5d11b247f8d8ff307dfca15a4c7fc07613b7b5b2

  Note: PCAC recommendations are advisory. Category 1 is a nomination under FDA evaluation, distinct from the final 503A Bulks List established by rulemaking. FDA’s January 2025 interim policy describes conditional enforcement discretion, not FDA approval or unconditional permission. Its Category 1 conditions include manufacturer registration, a valid certificate of analysis and all other applicable 503A conditions; that policy does not apply to Category 2. Assess the exact substance, form and route against the applicable monograph, approved-drug-component, final-list and interim-policy provisions.

  PCAC 07/23/2026 · reported source ↗
• Apr 16, 2026PCAC reviewFederal

  PCAC under-review tag recorded

  Stored event summary — not a current eligibility determination: Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

  Note: PCAC recommendations are advisory. Category 1 is a nomination under FDA evaluation, distinct from the final 503A Bulks List established by rulemaking. FDA’s January 2025 interim policy describes conditional enforcement discretion, not FDA approval or unconditional permission. Its Category 1 conditions include manufacturer registration, a valid certificate of analysis and all other applicable 503A conditions; that policy does not apply to Category 2. Assess the exact substance, form and route against the applicable monograph, approved-drug-component, final-list and interim-policy provisions.

  2026-07361 · primary source ↗

State overlays

No MSR event recorded in the published state history for TB-500. State boards hold independent authority; legislation is monitored via LegiScan and board positions are added as they are verified.