[
  {
    "slug": "pt-141",
    "name": "PT-141",
    "evidence": "A",
    "status": "FDA-approved (Vyleesi) for hypoactive sexual desire disorder in premenopausal women. Use in men or for other purposes is off-label.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "semaglutide",
    "name": "Semaglutide",
    "evidence": "A",
    "status": "FDA-approved for type 2 diabetes (Ozempic, Rybelsus), chronic weight management (Wegovy) and cardiovascular risk reduction in adults with obesity. Compounded versions are permitted only during declared shortages; shortage status must be verified.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "sermorelin",
    "name": "Sermorelin",
    "evidence": "A",
    "status": "Previously FDA-approved as Geref for pediatric growth hormone deficiency and diagnostic use; the approved product was discontinued in 2008 for commercial reasons. Widely compounded; its 503A basis must be verified against the current bulks list before publication.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "tesamorelin",
    "name": "Tesamorelin",
    "evidence": "A",
    "status": "FDA-approved (Egrifta) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Use for any other purpose is off-label.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "tirzepatide",
    "name": "Tirzepatide",
    "evidence": "A",
    "status": "FDA-approved for type 2 diabetes (Mounjaro), chronic weight management and obstructive sleep apnea in obesity (Zepbound). Compounding permitted only during declared shortages; shortage status must be verified.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "cjc-1295",
    "name": "CJC-1295",
    "evidence": "B",
    "status": "Not FDA-approved. Removed from 503A Category 2 in April 2026 following nomination withdrawal; not placed in Category 1. Compounding not covered by the 503A exemption.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "ghk-cu",
    "name": "GHK-Cu",
    "evidence": "B",
    "status": "Not an approved drug. Widely used as a cosmetic ingredient in topical products, which is regulated as a cosmetic, not a drug. Injectable use is not approved and its compounding status must be verified.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "ipamorelin",
    "name": "Ipamorelin",
    "evidence": "B",
    "status": "Not FDA-approved. Placed in 503A Category 2 in 2023. Its current category must be verified against the FDA bulks list before publication; it has not been listed in Category 1.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "selank",
    "name": "Selank",
    "evidence": "B",
    "status": "Not FDA-approved. Not on the 503A Bulks List. Status against the current FDA list must be verified before publication.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "semax",
    "name": "Semax",
    "evidence": "B",
    "status": "Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "thymosin-alpha-1",
    "name": "Thymosin alpha-1",
    "evidence": "B",
    "status": "Not FDA-approved. Placed in 503A Category 2 in 2023. Current category must be verified against the FDA bulks list before publication.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "bpc-157",
    "name": "BPC-157",
    "evidence": "C",
    "status": "Not FDA-approved for any use. Placed in 503A Category 2 in 2023 over immunogenicity and impurity concerns; removed from Category 2 on April 15, 2026 after nomination withdrawal — which is not a listing in Category 1. Reviewed by the Pharmacy Compounding Advisory Committee on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. Compounding remains outside the 503A exemption until rulemaking concludes.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "emideltide",
    "name": "Emideltide",
    "evidence": "C",
    "status": "Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "kpv",
    "name": "KPV",
    "evidence": "C",
    "status": "Not FDA-approved. Reviewed by PCAC on July 23, 2026; FDA proposed not to add it to the 503A Bulks List.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "ll-37",
    "name": "LL-37",
    "evidence": "C",
    "status": "Not FDA-approved. Previously withdrawn from review; FDA has announced a further PCAC meeting before the end of February 2027 to reconsider it for the 503A Bulks List.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "mots-c",
    "name": "MOTS-c",
    "evidence": "C",
    "status": "Not FDA-approved. Reviewed by PCAC on July 23, 2026; FDA proposed not to add it to the 503A Bulks List. Not eligible for compounding.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "tb-500",
    "name": "TB-500",
    "evidence": "C",
    "status": "Not FDA-approved. Removed from 503A Category 2 in April 2026; reviewed by PCAC on July 23, 2026 with FDA proposing not to list. Not eligible for 503A compounding.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "epitalon",
    "name": "Epitalon",
    "evidence": "D",
    "status": "Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  },
  {
    "slug": "melanotan-ii",
    "name": "Melanotan II",
    "evidence": "D",
    "status": "Not FDA-approved; FDA has issued consumer warnings. Previously withdrawn from review; FDA has announced a further PCAC meeting before the end of February 2027 to reconsider it.",
    "asOf": "2026-09-06",
    "source": "Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026"
  }
]