{
  "generated_utc": "2026-07-07T04:02:00+00:00",
  "dataset_version": "0.2.0-draft",
  "disclaimer": "Informational only. Not legal or medical advice. Confirm against FDA primary sources.",
  "key_dates": [
    {
      "date": "2023-09",
      "event": "FDA established the interim Category 2 grouping placing 19 peptides in the do-not-compound bucket.",
      "sources": [
        {
          "url": "https://www.biopharmadive.com/",
          "type": "trade",
          "date": "2026-04-16",
          "note": "date approximate; corroborate against FDA primary"
        }
      ],
      "confidence": "medium"
    },
    {
      "date": "2026-02-27",
      "event": "HHS Secretary R.F. Kennedy Jr. publicly signaled ~14 of 19 Category 2 peptides would move back toward Category 1.",
      "sources": [
        {
          "url": "https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means",
          "type": "trade",
          "date": "2026-02-27"
        }
      ],
      "confidence": "low",
      "caveat": "Secondary coverage of a podcast appearance. No primary HHS/FDA press release located. Superseded by the formal 2026-04-15 action for the 12 named peptides. Treat as historical signal."
    },
    {
      "date": "2026-04-15",
      "event": "FDA published removal of 12 peptides from Category 2. Removal is NOT authorization to compound.",
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
          "type": "law_firm",
          "date": "2026-04-17"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "confidence": "high"
    },
    {
      "date": "2026-04-16",
      "event": "Federal Register notice of the PCAC meeting published (distinct document from the Apr 15 removal notice).",
      "sources": [
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "confidence": "medium"
    },
    {
      "date": "2026-05-14",
      "event": "FDA reported to have restored non-injectable GHK-Cu to Category 1 on the 503A bulk drug substances list.",
      "sources": [
        {
          "url": "https://www.foley.com/insights/publications/2026/05/fda-to-consider-lifting-restrictions-on-numerous-compounded-peptides/",
          "type": "law_firm",
          "date": "2026-05"
        }
      ],
      "confidence": "low",
      "caveat": "Single law-firm source, and one summary conflicts (Hyman Phelps states these peptides were never on Category 1). Confirm against the FDA 503A bulk list directly before asserting any Category 1 status."
    },
    {
      "date": "2026-06-30",
      "event": "Deadline to request to make an oral presentation at the July PCAC meeting.",
      "sources": [
        {
          "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
          "type": "law_firm",
          "date": "2026-04-17"
        }
      ],
      "confidence": "low",
      "caveat": "Single source. Verify against the Federal Register."
    },
    {
      "date": "2026-07-09",
      "event": "Written comment submission deadline for the July PCAC meeting.",
      "sources": [
        {
          "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
          "type": "law_firm",
          "date": "2026-04-17"
        }
      ],
      "confidence": "low",
      "caveat": "Single source. Verify against the Federal Register."
    },
    {
      "date": "2026-07-23",
      "event": "PCAC meeting Day 1 (FDA White Oak, Silver Spring MD). Reviews BPC-157, KPV, TB-500, MOTs-C for the 503A bulk substances list.",
      "sources": [
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "confidence": "high"
    },
    {
      "date": "2026-07-24",
      "event": "PCAC meeting Day 2. Reviews Emideltide (DSIP), Semax, Epitalon.",
      "sources": [
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "confidence": "high"
    },
    {
      "date": "2027-02",
      "event": "Second PCAC meeting expected before end of Feb 2027 for the remaining 5: LL-37, Dihexa, GHK-Cu (injectable), Melanotan II, PEG-MGF.",
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "confidence": "medium"
    }
  ],
  "compounds": [
    {
      "name": "BPC-157",
      "category": "recovery",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 23, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-23",
        "forms": "free base and acetate"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "KPV",
      "category": "recovery",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 23, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-23",
        "forms": "free base and acetate"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "TB-500",
      "category": "recovery",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 23, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-23",
        "forms": "free base and acetate"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "MOTs-C",
      "category": "metabolic",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 23, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-23",
        "forms": "free base and acetate"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "Emideltide (DSIP)",
      "category": "cognitive",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 24, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-24"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "Semax",
      "category": "cognitive",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 24, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-24"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "Epitalon",
      "category": "longevity",
      "status_code": "under_pcac_review",
      "status_label": "Removed from Category 2 (Apr 2026), under PCAC review Jul 24, 2026",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2026-07-24"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
          "type": "fda",
          "date": "2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "Cathelicidin LL-37",
      "category": "recovery",
      "status_code": "removed_from_cat2",
      "status_label": "Removed from Category 2 (Apr 2026), second PCAC review expected by Feb 2027",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2027-02",
        "note": "second PCAC meeting, before end of Feb 2027"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "Dihexa",
      "category": "cognitive",
      "status_code": "removed_from_cat2",
      "status_label": "Removed from Category 2 (Apr 2026), second PCAC review expected by Feb 2027",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2027-02",
        "note": "second PCAC meeting, before end of Feb 2027"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "GHK-Cu (injectable)",
      "category": "recovery",
      "status_code": "removed_from_cat2",
      "status_label": "Injectable form removed from Category 2 (Apr 2026), second PCAC review expected by Feb 2027",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2027-02",
        "note": "second PCAC meeting, before end of Feb 2027"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "GHK-Cu (non-injectable)",
      "category": "recovery",
      "status_code": "removed_from_cat2",
      "status_label": "Non-injectable form reported restored to Category 1 (May 14, 2026), disputed",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.foley.com/insights/publications/2026/05/fda-to-consider-lifting-restrictions-on-numerous-compounded-peptides/",
          "type": "law_firm",
          "date": "2026-05"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Melanotan II",
      "category": "dermatologic",
      "status_code": "removed_from_cat2",
      "status_label": "Removed from Category 2 (Apr 2026), second PCAC review expected by Feb 2027",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2027-02",
        "note": "second PCAC meeting, before end of Feb 2027"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "PEG-MGF",
      "category": "hormonal",
      "status_code": "removed_from_cat2",
      "status_label": "Removed from Category 2 (Apr 2026), second PCAC review expected by Feb 2027",
      "confidence": "high",
      "pcac": {
        "scheduled": true,
        "date": "2027-02",
        "note": "second PCAC meeting, before end of Feb 2027"
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/",
          "type": "law_firm",
          "date": "2026-04-16"
        },
        {
          "url": "https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/",
          "type": "law_firm",
          "date": "2026-04-21"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": false
    },
    {
      "name": "CJC-1295",
      "category": "hormonal",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means",
          "type": "trade",
          "date": "2026-02-27",
          "note": "named in reclassification coverage; specific current status not confirmed"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Ipamorelin",
      "category": "hormonal",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means",
          "type": "trade",
          "date": "2026-02-27",
          "note": "named in reclassification coverage; current status unconfirmed"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Sermorelin",
      "category": "hormonal",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Thymosin Alpha-1",
      "category": "longevity",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means",
          "type": "trade",
          "date": "2026-02-27",
          "note": "named in reclassification coverage"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "AOD-9604",
      "category": "metabolic",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means",
          "type": "trade",
          "date": "2026-02-27",
          "note": "named in reclassification coverage"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Selank",
      "category": "cognitive",
      "status_code": "unknown",
      "status_label": "Current 503A classification not verified in this dataset",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Tesamorelin",
      "category": "hormonal",
      "status_code": "fda_approved",
      "status_label": "FDA-approved drug (Egrifta), compounding governed by different rules",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "PT-141 (Bremelanotide)",
      "category": "sexual",
      "status_code": "fda_approved",
      "status_label": "FDA-approved drug (Vyleesi), compounding governed by different rules",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Semaglutide (compounded)",
      "category": "metabolic",
      "status_code": "fda_approved",
      "status_label": "Reference drug FDA-approved (Ozempic/Wegovy), compounded version tied to shortage-list status",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s",
          "type": "fda",
          "date": "2026-03"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Tirzepatide (compounded)",
      "category": "metabolic",
      "status_code": "fda_approved",
      "status_label": "Reference drug FDA-approved (Mounjaro/Zepbound), compounded version tied to shortage-list status",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s",
          "type": "fda",
          "date": "2026-03"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Retatrutide",
      "category": "metabolic",
      "status_code": "investigational",
      "status_label": "Investigational (not FDA-approved), not on the 503A bulks list",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025",
          "type": "fda",
          "date": "2025-09-09",
          "note": "WL states retatrutide is not the subject of a USP/NF monograph and not a component of an FDA-approved drug"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "5-Amino-1MQ",
      "category": "metabolic",
      "status_code": "unknown",
      "status_label": "Current status pending sourcing",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Glutathione (compounded)",
      "category": "recovery",
      "status_code": "unclassified",
      "status_label": "PCAC recommended for the 503A bulks list (2022); final rule status unconfirmed",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://a4pc.org/news/",
          "type": "trade",
          "date": "2022-06",
          "note": "PCAC voted 8-5 (1 abstention) to recommend glutathione, overriding FDA staff; final rule not confirmed 2023-2026"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "NAD+ (compounded)",
      "category": "longevity",
      "status_code": "cat2_restricted",
      "status_label": "Category 2 (FDA proposed NOT to add to the 503A bulks list)",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/media/94155/download",
          "type": "fda",
          "date": "2026-05-14",
          "note": "FDA bulk-substances evaluation doc places NAD in Category 2; page 404'd on automated fetch, confirm by browser"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "NMN",
      "category": "longevity",
      "status_code": "dietary_supplement",
      "status_label": "Regulated as a dietary supplement (FDA reversed its exclusion, Sept 2025)",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.venable.com/insights/publications/2025/10",
          "type": "law_firm",
          "date": "2025-10",
          "note": "FDA Sept 29 2025 letters conclude NMN was marketed as a supplement pre-IND (race-to-market exception)"
        },
        {
          "url": "https://www.nutraingredients-usa.com/",
          "type": "trade",
          "date": "2025-09-30"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Pinealon",
      "category": "longevity",
      "status_code": "unknown",
      "status_label": "Current status pending sourcing",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Elamipretide",
      "category": "longevity",
      "status_code": "fda_approved",
      "status_label": "FDA-approved for Barth syndrome only (Forzinity, Sep 2025); investigational for all other uses",
      "confidence": "high",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome",
          "type": "fda",
          "date": "2025-09-19"
        },
        {
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/",
          "type": "fda",
          "date": "2025-09-19",
          "note": "NDA 215244 approval package"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Thymulin",
      "category": "longevity",
      "status_code": "unknown",
      "status_label": "Current status pending sourcing",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Vitamin B12 (compounded)",
      "category": "longevity",
      "status_code": "fda_approved",
      "status_label": "FDA-approved drug; compoundable via the approved-drug-component pathway",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://dailymed.nlm.nih.gov/dailymed/",
          "type": "gov",
          "date": "undated",
          "note": "Cyanocobalamin injection USP is a long-standing approved drug; confirm specific NDA/ANDA in the Orange Book before publish"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Kisspeptin-10",
      "category": "hormonal",
      "status_code": "cat2_restricted",
      "status_label": "Category 2 (PCAC voted against adding to the 503A bulks list, Oct 29 2024)",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://a4pc.org/news/",
          "type": "trade",
          "date": "2024-11",
          "note": "reports the Oct 29 2024 PCAC vote against kisspeptin-10, ipamorelin, ibutamoren, L-theanine"
        },
        {
          "url": "https://www.fda.gov/media/183155/download",
          "type": "fda",
          "date": "2024-10-29",
          "note": "PCAC meeting materials; confirm voting tally by browser"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Gonadorelin",
      "category": "hormonal",
      "status_code": "unknown",
      "status_label": "Widely compounded; precise current 503A category unconfirmed",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://fagronacademy.us/",
          "type": "blog",
          "date": "2023-10",
          "note": "single industry blog states gonadorelin added to Category 1 for 503B; 503A status not confirmed against FDA primary"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "HCG",
      "category": "hormonal",
      "status_code": "not_503a_eligible",
      "status_label": "Biologic under PHS Act 351; NOT eligible for 503A/503B compounding",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revive-rx-llc-dba-revive-rx-pharmacy-709509-09222025",
          "type": "fda",
          "date": "2025-09-22",
          "note": "WL: HCG and Thymosin Beta-4 are biological products under PHS Act 351, not eligible for 503A/503B exemptions"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Oxytocin (compounded)",
      "category": "sexual",
      "status_code": "fda_approved",
      "status_label": "FDA-approved (Pitocin, injectable); nasal/sublingual is off-label compounding",
      "confidence": "medium",
      "pcac": {
        "scheduled": false
      },
      "components": null,
      "sources": [
        {
          "url": "https://dailymed.nlm.nih.gov/dailymed/",
          "type": "gov",
          "date": "undated",
          "note": "Pitocin (oxytocin injection USP) approved for labor induction/PPH"
        },
        {
          "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-risk-alerts",
          "type": "fda",
          "date": "undated",
          "note": "checked, no oxytocin-specific alert found as of 2026-07-06"
        }
      ],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Wolverine Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "BPC-157",
        "TB-500"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Glow Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "GHK-Cu (injectable)",
        "BPC-157",
        "TB-500"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Klow Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "BPC-157",
        "TB-500",
        "KPV",
        "GHK-Cu (injectable)"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Recompose Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "Tesamorelin",
        "Ipamorelin"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Focus Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "Semax",
        "Selank"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    },
    {
      "name": "Fortify Blend",
      "category": "blends",
      "status_code": "unknown",
      "status_label": "Follows components",
      "confidence": "low",
      "pcac": {
        "scheduled": false
      },
      "components": [
        "Thymosin Alpha-1",
        "Thymulin"
      ],
      "sources": [],
      "last_verified": "2026-07-06",
      "provisional": true
    }
  ]
}