{
  "dataset": {
    "name": "Peptides.NYC US Peptide Regulatory Status Tracker",
    "description": "A dated, primary-sourced record of the US regulatory status of research and compounded peptides: FDA approval status, section 503A and 503B bulk-substance categories tracked separately, Pharmacy Compounding Advisory Committee history, next scheduled review, and WADA listing, with a public changelog.",
    "license": "https://peptides.nyc/terms",
    "dateModified": "2026-09-01"
  },
  "asOf": "2026-09-01",
  "lastVerified": "2026-09-16",
  "generatedFrom": "src/data/regulatory/status.ts",
  "records": [
    {
      "slug": "bpc-157",
      "name": "BPC-157",
      "route": "all",
      "entityKey": "bpc-157",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "FDA's July 2026 PCAC briefing document states there is no approved product containing BPC-157-related bulk drug substances, and BPC-157 is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a). USADA states the same: the substance \"is not approved for human clinical use by the U.S. Food and Drug Administration (FDA) or any other global health authority\".",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: BPC-157-related bulk drug substances",
            "url": "https://www.fda.gov/media/193343/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "USADA, BPC-157: What Athletes Should Know About the Prohibited Experimental Peptide",
            "url": "https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/",
            "publisher": "U.S. Anti-Doping Agency",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-23",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including BPC-157 on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and BPC-157 is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: BPC-157-related bulk drug substances",
              "url": "https://www.fda.gov/media/193343/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "wada": {
        "prohibitedClass": "S0",
        "listUrl": "https://www.wada-ama.org/en/prohibited-list",
        "note": "USADA states that BPC-157 is prohibited under the S0 Non-Approved Substances category of the WADA Prohibited List, and that a TUE is unlikely to be granted. The Prohibited List is revised annually — check the live list linked here."
      },
      "relatedSlugs": [
        "bpc-157-complete-guide",
        "is-bpc-157-legal-online",
        "are-peptides-legal"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-23",
          "summary": "PCAC discussed BPC-157 and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and BPC-157 has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed BPC-157 among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, BPC-157 among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "kpv",
      "name": "KPV",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "KPV is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: KPV-related bulk drug substances",
            "url": "https://www.fda.gov/media/193346/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-23",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including KPV on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and KPV is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: KPV-related bulk drug substances",
              "url": "https://www.fda.gov/media/193346/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "kpv-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-23",
          "summary": "PCAC discussed KPV and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and KPV has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed KPV among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, KPV among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "tb-500",
      "name": "TB-500",
      "route": "all",
      "entityKey": "tb-500",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "TB-500 (thymosin beta-4 fragment, LKKTETQ) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: TB-500-related bulk drug substances",
            "url": "https://www.fda.gov/media/193349/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-23",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including TB-500 on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and TB-500 is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: TB-500-related bulk drug substances",
              "url": "https://www.fda.gov/media/193349/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "tb-500-complete-guide",
        "tb-500-fda-pcac-2026"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-23",
          "summary": "PCAC discussed TB-500 and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and TB-500 has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed TB-500 (thymosin beta-4, fragment (LKKTETQ)) among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, TB-500 among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "mots-c",
      "name": "MOTS-c",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "MOTS-c is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: MOTS-c-related bulk drug substances",
            "url": "https://www.fda.gov/media/193347/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-23",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including MOTS-c on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and MOTS-c is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: MOTS-c-related bulk drug substances",
              "url": "https://www.fda.gov/media/193347/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "mots-c-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-23",
          "summary": "PCAC discussed MOTS-c and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and MOTS-c has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed MOTS-c among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, MOTS-c among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "semax",
      "name": "Semax",
      "route": "all",
      "entityKey": "semax",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Semax (heptapeptide) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Semax-related bulk drug substances",
            "url": "https://www.fda.gov/media/193348/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-24",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including Semax on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and Semax is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Semax-related bulk drug substances",
              "url": "https://www.fda.gov/media/193348/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "semax-amidate-protocol",
        "semax-vs-selank"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-24",
          "summary": "PCAC discussed Semax and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and Semax has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed Semax (heptapeptide) among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, Semax among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "epitalon",
      "name": "Epitalon",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Epitalon is not an FDA-approved drug; FDA's July 2026 PCAC briefing document records that there are no approved products containing epitalon in Canada, Australia or the other jurisdictions it surveyed, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-related bulk drug substances",
            "url": "https://www.fda.gov/media/193345/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-24",
          "outcome": "recommended",
          "note": "PCAC voted in favor of including Epitalon on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and Epitalon is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-related bulk drug substances",
              "url": "https://www.fda.gov/media/193345/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "epitalon-vs-longevity-peptides"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-24",
          "summary": "PCAC discussed Epitalon and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and Epitalon has not been added to that list.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed Epitalon among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, Epitalon among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "emideltide",
      "name": "Emideltide (DSIP)",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Emideltide, also called delta sleep-inducing peptide (DSIP), is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Emideltide-related bulk drug substances",
            "url": "https://www.fda.gov/media/193344/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [
        {
          "date": "2026-07-24",
          "outcome": "rejected",
          "note": "PCAC voted against including emideltide (DSIP) on the 503A Bulks List. FDA has published no minutes or transcript, so no vote tally is recorded here.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Emideltide-related bulk drug substances",
              "url": "https://www.fda.gov/media/193344/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ],
      "relatedSlugs": [
        "dsip-protocol",
        "best-peptides-for-sleep"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-07-24",
          "summary": "PCAC discussed emideltide (DSIP) and voted against adding it to the 503A Bulks List.",
          "sources": [
            {
              "label": "FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee",
              "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
              "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026",
              "url": "https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound",
              "publisher": "National Community Pharmacists Association",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed emideltide (DSIP) among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-16",
          "summary": "FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, emideltide (DSIP) among them, and opened a public docket for comment.",
          "sources": [
            {
              "label": "Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026",
              "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ll-37",
      "name": "Cathelicidin LL-37",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Cathelicidin LL-37 is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "ll-37-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed cathelicidin LL-37 among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "dihexa",
      "name": "Dihexa",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Dihexa acetate is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "dihexa-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed dihexa acetate among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "peg-mgf",
      "name": "PEG-MGF",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Mechano growth factor pegylated (PEG-MGF) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "mgf-peg-mgf-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed mechano growth factor pegylated (PEG-MGF) among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "melanotan-ii",
      "name": "Melanotan II",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Melanotan II is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "melanotan-ii-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed melanotan II among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-15",
          "summary": "FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.",
          "sources": [
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ghk-cu",
      "name": "GHK-Cu",
      "route": "non-injectable",
      "entityKey": "ghk-cu",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "GHK-Cu is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "category-1",
        "asOf": "2026-05-14",
        "note": "FDA lists \"GHK-Cu (except for injectable routes of administration)\" in 503A category 1. In FDA's words: it \"was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators. On May 5, 2026, one of those nominators clarified that it intended to withdraw only its nomination of the injectable route of administration ... GHK-Cu (except for injectable routes of administration) will be added back to category 1.\" The non-injectable route is not named anywhere on FDA's bulk drug substances page — neither in its category 2 table nor in its withdrawn table, which lists only the injectable entry — so it was not part of the April 2026 category 2 removals. Orrick reports, as a secondary source, that GHK-Cu moved on the category 1 list rather than category 2. Read the withdrawn table's heading loosely: it calls its entries substances \"previously in category 2 of the interim policies\", yet FDA annotates ipamorelin acetate in that same table as still being in category 2 under the 503B interim policy. Category 1 is enforcement discretion under an interim policy, not inclusion on the 503A Bulks List, which holds six substances and no peptides.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
            "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
            "publisher": "Orrick, Herrington & Sutcliffe LLP",
            "confidence": "secondary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "nextReview": {
        "by": "2027-02-28",
        "description": "FDA \"has announced it intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list.\" FDA names GHK-Cu there without a route qualifier, unlike the route-qualified category 1 sentence immediately before it, so the document does not say whether the consultation covers both routes or only the non-injectable one. Nothing is inferred here either way.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "relatedSlugs": [
        "ghk-cu-benefits",
        "ghk-cu-topical-vs-injectable",
        "ghk-cu-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-05-05",
          "summary": "One nominator clarified that it had meant to withdraw only its nomination of the injectable route, so FDA said GHK-Cu except for injectable routes of administration would be added back to 503A category 1.",
          "sources": [
            {
              "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
              "url": "https://www.fda.gov/media/94155/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "The nominations for GHK-Cu were withdrawn by the nominators, and FDA removed \"GHK-Cu (except for injectable routes of administration)\" from 503A category 1. Orrick reports this as a category 1 action, separate from the 12 peptides removed from category 2 the same day.",
          "sources": [
            {
              "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
              "url": "https://www.fda.gov/media/94155/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
              "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
              "publisher": "Orrick, Herrington & Sutcliffe LLP",
              "confidence": "secondary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ghk-cu",
      "name": "GHK-Cu",
      "route": "injectable",
      "entityKey": "ghk-cu",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "GHK-Cu for injectable routes of administration is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "note": "FDA lists \"GHK-Cu (for injectable routes of administration)\" among the bulk drug substances nominated but withdrawn, in a table headed \"This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.\" FDA's section 503A nomination document says something different in shape: that \"the nominations for GHK-Cu were withdrawn by the nominators\", and that the route-qualified entry \"GHK-Cu (except for injectable routes of administration)\" came off category 1 on April 22, 2026. What FDA dates to May 5, 2026 is a nominator's clarification that it had meant to withdraw only the injectable route and wished to retain its non-injectable nomination; of the listing itself FDA writes only that the entry \"will be added back to category 1\", and the document as updated May 14, 2026 does carry it there. Neither document states which category the injectable route itself occupied before the withdrawal, and this tracker does not resolve it; Orrick reports, as a secondary source, that FDA removed GHK-Cu from category 1 as a whole. Treat the withdrawn table's heading as loose: FDA annotates ipamorelin acetate in the same table as still being in category 2 under the 503B interim policy. What is not in dispute is that the injectable nomination was withdrawn, was not among those retained, and is on no positive list today: it is in neither 503A category 1 nor the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026",
            "url": "https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings",
            "publisher": "Orrick, Herrington & Sutcliffe LLP",
            "confidence": "secondary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "nextReview": {
        "by": "2027-02-28",
        "description": "FDA \"has announced it intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list.\" FDA names GHK-Cu there without a route qualifier, unlike the route-qualified category 1 sentence immediately before it, so the document does not say whether the consultation covers both routes or only the non-injectable one. Nothing is inferred here either way.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "relatedSlugs": [
        "ghk-cu-topical-vs-injectable",
        "ghk-cu-benefits"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-05-05",
          "summary": "One of the nominators clarified that it had intended to withdraw only its nomination of the injectable route of administration, so FDA added back GHK-Cu except for injectable routes of administration; the injectable route was not restored to category 1.",
          "sources": [
            {
              "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
              "url": "https://www.fda.gov/media/94155/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-22",
          "summary": "The nominations for GHK-Cu were withdrawn by the nominators, and FDA removed \"GHK-Cu (except for injectable routes of administration)\" from 503A category 1. FDA's bulk drug substances page lists \"GHK-Cu (for injectable routes of administration)\" among the substances nominated but withdrawn.",
          "sources": [
            {
              "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
              "url": "https://www.fda.gov/media/94155/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            },
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ghrp-2",
      "name": "GHRP-2",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Growth hormone releasing peptide-2 (GHRP-2) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "category-3",
        "asOf": "2026-05-14",
        "note": "FDA places GHRP-2 in 503A category 3, \"Bulk Drug Substances Nominated Without Adequate Support\".",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "FDA's entry is route-qualified: \"Growth hormone releasing peptide-2 (GHRP-2) (for injectable and nasal routes of administration)\", added to 503B category 2 on September 29, 2023. GHRP-2 for other routes sits in 503B category 1.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "ghrp-2-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, continued to list GHRP-2 for injectable and nasal routes of administration in category 2 under the 503B interim policy.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ghrp-6",
      "name": "GHRP-6",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Growth hormone releasing peptide-6 (GHRP-6) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "category-3",
        "asOf": "2026-05-14",
        "note": "FDA places GHRP-6 in 503A category 3, \"Bulk Drug Substances Nominated Without Adequate Support\".",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "Added to 503B category 2 on September 29, 2023.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "ghrp-6-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, continued to list GHRP-6 in category 2 under the 503B interim policy.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ibutamoren",
      "name": "Ibutamoren mesylate (MK-677)",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Ibutamoren mesylate is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "Added to 503A category 2 on September 29, 2023.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "Added to 503B category 2 on December 29, 2022.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "mk-677-protocol",
        "mk-677-vs-cjc-1295-ipamorelin"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, continued to list ibutamoren mesylate in category 2 under the 503A and 503B interim policy.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "ipamorelin",
      "name": "Ipamorelin acetate",
      "route": "all",
      "entityKey": "ipamorelin",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Ipamorelin acetate is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "note": "The withdrawal cleared ipamorelin acetate from the 503A list only: it appears in none of the three categories on FDA's section 503A nomination document, and it remains in category 2 for 503B outsourcing-facility compounding. Neither document dates the withdrawal, so no date is asserted here.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "Added to 503B category 2 on September 29, 2023. FDA notes on its own page that ipamorelin acetate \"also appears in the table above because it is in category 2 under the 503B interim policy\".",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "ipamorelin-protocol",
        "sermorelin-vs-ipamorelin"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed ipamorelin acetate both among the nominations that were withdrawn and in category 2 under the 503B interim policy.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "kisspeptin-10",
      "name": "Kisspeptin-10",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Kisspeptin-10 is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "category-2",
        "asOf": "2026-04-22",
        "note": "Added to 503A category 2 on September 29, 2023.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "gonadorelin-kisspeptin-protocol"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, continued to list kisspeptin-10 in category 2 under the 503A interim policy.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "cjc-1295",
      "name": "CJC-1295",
      "route": "all",
      "entityKey": "cjc-1295",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "CJC-1295 is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "note": "CJC-1295 came off 503A category 2 but was never added to category 1, so there is still no lawful 503A compounding pathway.",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "cjc-1295-protocol",
        "cjc-1295-vs-ipamorelin"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed CJC-1295 among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "aod-9604",
      "name": "AOD-9604",
      "route": "all",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "AOD-9604 is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "aod-9604-protocol",
        "aod-9604-vs-glp-1"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed AOD-9604 among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "selank",
      "name": "Selank",
      "route": "all",
      "entityKey": "selank",
      "fdaApproval": {
        "status": "not-approved",
        "detail": "Selank acetate (TP-7) is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides)",
            "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "nominated-withdrawn",
        "asOf": "2026-04-22",
        "sources": [
          {
            "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
            "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "na-semax-selank-protocol",
        "semax-vs-selank"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-04-22",
          "summary": "FDA's bulk drug substances page, content current as of this date, listed selank acetate (TP-7) among the substances nominated but withdrawn rather than in category 2.",
          "sources": [
            {
              "label": "FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus \"bulk drug substances nominated but withdrawn\"), content current as of April 22, 2026",
              "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "sermorelin",
      "name": "Sermorelin",
      "route": "all",
      "entityKey": "sermorelin",
      "fdaApproval": {
        "status": "approved",
        "detail": "FDA approved GEREF (sermorelin acetate) under NDA 019863 on December 28, 1990 as a new molecular entity. Drugs@FDA shows the product as Discontinued, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons.",
        "sources": [
          {
            "label": "Drugs@FDA, NDA 019863 (GEREF, sermorelin acetate)",
            "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "category-1",
        "asOf": "2025-03-21",
        "note": "FDA lists \"Sermorelin Acetate\" in 503B category 1 and marks it with the two asterisks it uses for category 1 substances that are components of FDA-approved drugs.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "sermorelin-protocol",
        "sermorelin-vs-ipamorelin"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2025-03-21",
          "summary": "FDA's categorized 503B nomination list, updated this date, placed sermorelin acetate in category 1 and flagged it as a component of an FDA-approved drug.",
          "sources": [
            {
              "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
              "url": "https://www.fda.gov/media/94164/download",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "1990-12-28",
          "summary": "FDA approved GEREF (sermorelin acetate) under NDA 019863.",
          "sources": [
            {
              "label": "Drugs@FDA, NDA 019863 (GEREF, sermorelin acetate)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "tesamorelin",
      "name": "Tesamorelin",
      "route": "all",
      "entityKey": "tesamorelin",
      "fdaApproval": {
        "status": "approved",
        "detail": "FDA approved EGRIFTA (tesamorelin acetate) under application 022505 on November 10, 2010. Drugs@FDA records that the former NDA was deemed to be a BLA on March 23, 2020.",
        "sources": [
          {
            "label": "Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate)",
            "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "tesamorelin-protocol",
        "tesamorelin-for-visceral-fat"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2020-03-23",
          "summary": "The EGRIFTA application was deemed to be a biologics license application.",
          "sources": [
            {
              "label": "Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2010-11-10",
          "summary": "FDA approved EGRIFTA (tesamorelin acetate) under application 022505.",
          "sources": [
            {
              "label": "Drugs@FDA, application 022505 (EGRIFTA, tesamorelin acetate)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "semaglutide",
      "name": "Semaglutide",
      "route": "all",
      "entityKey": "semaglutide",
      "fdaApproval": {
        "status": "approved",
        "detail": "FDA approved OZEMPIC (semaglutide injection) under NDA 209637 on December 5, 2017 as a new molecular entity.",
        "sources": [
          {
            "label": "Drugs@FDA, NDA 209637 (OZEMPIC, semaglutide injection)",
            "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "proposed-for-exclusion",
        "asOf": "2026-05-01",
        "note": "FDA considered the nominations and proposes NOT to include semaglutide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.",
        "sources": [
          {
            "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
            "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
            "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "semaglutide-complete-guide",
        "semaglutide-compounding-ban-2026"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-09-01",
          "summary": "The Fifth Circuit's revised opinion issued in Outsourcing Facilities Ass'n v. FDA, No. 25-10758, affirming the district court's judgment for FDA.",
          "sources": [
            {
              "label": "Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026; opinion revised Sept. 1, 2026)",
              "url": "https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf",
              "publisher": "U.S. Court of Appeals for the Fifth Circuit",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-08-27",
          "summary": "The Fifth Circuit affirmed against the compounders in Outsourcing Facilities Ass'n v. FDA, No. 25-10758, an appeal over FDA's resolution of the semaglutide shortage.",
          "sources": [
            {
              "label": "Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026; opinion revised Sept. 1, 2026)",
              "url": "https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf",
              "publisher": "U.S. Court of Appeals for the Fifth Circuit",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-05-01",
          "summary": "FDA published a Federal Register notice proposing not to include semaglutide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.",
          "sources": [
            {
              "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
              "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-30",
          "summary": "FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.",
          "sources": [
            {
              "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
              "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2017-12-05",
          "summary": "FDA approved OZEMPIC (semaglutide injection) under NDA 209637.",
          "sources": [
            {
              "label": "Drugs@FDA, NDA 209637 (OZEMPIC, semaglutide injection)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "tirzepatide",
      "name": "Tirzepatide",
      "route": "all",
      "entityKey": "tirzepatide",
      "fdaApproval": {
        "status": "approved",
        "detail": "FDA approved MOUNJARO (tirzepatide injection) under NDA 215866 on May 13, 2022 as a new molecular entity, under priority review.",
        "sources": [
          {
            "label": "Drugs@FDA, NDA 215866 (MOUNJARO, tirzepatide injection)",
            "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "proposed-for-exclusion",
        "asOf": "2026-05-01",
        "note": "FDA considered the nominations and proposes NOT to include tirzepatide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.",
        "sources": [
          {
            "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
            "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
            "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "tirzepatide-protocol",
        "tirzepatide-vs-semaglutide-weight-loss"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-08-27",
          "summary": "In Outsourcing Facilities Ass'n v. FDA, No. 25-10758, the Fifth Circuit affirmed for the same reasons it had affirmed the district court's judgment in the companion Eli Lilly appeal over compounded tirzepatide.",
          "sources": [
            {
              "label": "Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026; opinion revised Sept. 1, 2026)",
              "url": "https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf",
              "publisher": "U.S. Court of Appeals for the Fifth Circuit",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-05-01",
          "summary": "FDA published a Federal Register notice proposing not to include tirzepatide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.",
          "sources": [
            {
              "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
              "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-30",
          "summary": "FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.",
          "sources": [
            {
              "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
              "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2022-05-13",
          "summary": "FDA approved MOUNJARO (tirzepatide injection) under NDA 215866.",
          "sources": [
            {
              "label": "Drugs@FDA, NDA 215866 (MOUNJARO, tirzepatide injection)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "liraglutide",
      "name": "Liraglutide",
      "route": "all",
      "fdaApproval": {
        "status": "approved",
        "detail": "FDA approved VICTOZA (liraglutide injection) under NDA 022341 on January 25, 2010 as a new molecular entity.",
        "sources": [
          {
            "label": "Drugs@FDA, NDA 022341 (VICTOZA, liraglutide injection)",
            "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022341",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "proposed-for-exclusion",
        "asOf": "2026-05-01",
        "note": "FDA considered the nominations and proposes NOT to include liraglutide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.",
        "sources": [
          {
            "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
            "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
            "publisher": "Office of the Federal Register",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
            "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "compounded-vs-brand-glp-1",
        "glp-1-cost-comparison"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-05-01",
          "summary": "FDA published a Federal Register notice proposing not to include liraglutide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.",
          "sources": [
            {
              "label": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026",
              "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
              "publisher": "Office of the Federal Register",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2026-04-30",
          "summary": "FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.",
          "sources": [
            {
              "label": "FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026",
              "url": "https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        },
        {
          "date": "2010-01-25",
          "summary": "FDA approved VICTOZA (liraglutide injection) under NDA 022341.",
          "sources": [
            {
              "label": "Drugs@FDA, NDA 022341 (VICTOZA, liraglutide injection)",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022341",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    },
    {
      "slug": "retatrutide",
      "name": "Retatrutide",
      "route": "all",
      "entityKey": "retatrutide",
      "fdaApproval": {
        "status": "investigational",
        "detail": "Retatrutide (LY3437943) is an investigational agent in phase 3 trials sponsored by Eli Lilly and Company. FDA has told sellers in writing that products offered as \"Retatrutide\" are unapproved new drugs under section 505(a) of the FD&C Act.",
        "sources": [
          {
            "label": "ClinicalTrials.gov, NCT06662383: \"A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity\" (Eli Lilly and Company; active, not recruiting)",
            "url": "https://clinicaltrials.gov/study/NCT06662383",
            "publisher": "U.S. National Library of Medicine",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          },
          {
            "label": "FDA warning letter to Gram Peptides (MARCS-CMS 721806), March 31, 2026: \"Retatrutide\" and \"Tirzepatide\" products are unapproved new drugs under section 505(a)",
            "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503a": {
        "category": "not-nominated",
        "asOf": "2026-05-14",
        "note": "Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026",
            "url": "https://www.fda.gov/media/94155/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "cat503b": {
        "category": "not-nominated",
        "asOf": "2025-03-21",
        "note": "Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.",
        "sources": [
          {
            "label": "FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025",
            "url": "https://www.fda.gov/media/94164/download",
            "publisher": "U.S. Food and Drug Administration",
            "confidence": "primary",
            "retrieved": "2026-09-16"
          }
        ]
      },
      "pcac": [],
      "relatedSlugs": [
        "retatrutide-protocol",
        "retatrutide-2026-results"
      ],
      "lastVerified": "2026-09-16",
      "changelog": [
        {
          "date": "2026-03-31",
          "summary": "FDA issued a warning letter to Gram Peptides stating that the \"Retatrutide\" and \"Tirzepatide\" products it offered for sale are unapproved new drugs under section 505(a) of the FD&C Act.",
          "sources": [
            {
              "label": "FDA warning letter to Gram Peptides (MARCS-CMS 721806), March 31, 2026: \"Retatrutide\" and \"Tirzepatide\" products are unapproved new drugs under section 505(a)",
              "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026",
              "publisher": "U.S. Food and Drug Administration",
              "confidence": "primary",
              "retrieved": "2026-09-16"
            }
          ]
        }
      ]
    }
  ]
}