{
 "generated": "2026-10-15",
 "license": "CC BY 4.0",
 "publisher": "My Peptide Information",
 "sources": {
  "fda_503a_bulks_page": {
   "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act",
   "content_current_as_of": "05/14/2026",
   "quote_category_1": "These substances may be eligible for inclusion on the 503A bulks list.",
   "quote_category_2": "FDA has identified significant safety risks relating to the use of these substances in compounding.",
   "quote_category_3": "These substances may be eligible for inclusion on the 503A bulks list but were nominated with insufficient supporting information for FDA to evaluate them.",
   "quote_cutoff": "the agency does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories."
  },
  "fda_interim_categories_pdf": {
   "url": "https://www.fda.gov/media/94155/download?attachment",
   "document_date": "Updated May 14, 2026",
   "category_2_503A_full_list_as_of_pdf": [
    "Cesium Chloride",
    "Domperidone",
    "Germanium Sesquioxide",
    "Ibutamoren Mesylate",
    "Kisspeptin-10",
    "Quinacrine Hydrochloride for intrauterine administration"
   ],
   "quote_ghk_cu": "GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators.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 with respect to GHK-Cu and would like to retain its nomination for GHK-Cu for non-injectable routes of administration. GHK-Cu (except for injectable routes of administration) will be added back to category 1. 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_category_2_safety_risks_page": {
   "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
   "content_current_as_of": "04/22/2026",
   "quote": "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.",
   "withdrawn_list_on_page": [
    "AOD-9604",
    "BPC-157",
    "Cathelicidin LL-37",
    "CJC-1295",
    "Dihexa acetate",
    "Emideltide (DSIP)",
    "Epitalon",
    "GHK-Cu (for injectable routes of administration)",
    "Ipamorelin acetate (still 503B category 2)",
    "KPV",
    "Mechano growth factor pegylated (PEG-MGF)",
    "Melanotan II",
    "MOTs-C",
    "Selank acetate (TP-7)",
    "Semax (heptapeptide)",
    "Thymosin-alpha 1 (Ta1)",
    "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500"
   ]
  },
  "pcac_july_2026": {
   "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
   "content_current_as_of": "08/06/2026",
   "dates": "July 23 - 24, 2026",
   "docket": "FDA-2025-N-6895",
   "agenda_july_23": "BPC-157 (free base)/BPC-157 acetate: ulcerative colitis; KPV: wound healing and inflammatory conditions; TB-500 (free base)/TB-500 acetate: wound healing; MOTs-C: obesity and osteoporosis",
   "agenda_july_24": "Emideltide (DSIP): opioid withdrawal, chronic insomnia, narcolepsy; Semax: cerebral ischemia, migraine, trigeminal neuralgia; Epitalon: insomnia",
   "fda_page_status_note": "As read on 2026-10-15 the FDA page lists pre-meeting materials only; no minutes, transcript or voting results were posted there.",
   "fda_staff_position_bpc157": {
    "url": "https://www.fda.gov/media/193343/download",
    "quote": "Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List."
   },
   "fda_staff_position_tb500": {
    "url": "https://www.fda.gov/media/193349/download",
    "quote": "Accordingly, we propose not adding TB-500 (free base) or TB-500 acetate to the 503A Bulks List."
   },
   "fda_presentation_note": {
    "url": "https://www.fda.gov/media/193773/download",
    "quote": "The nominations were withdrawn, and FDA is evaluating these substances at its discretion"
   },
   "reported_votes": {
    "source_url": "https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/",
    "publisher": "McDermott Will & Schulte (law firm insight)",
    "published": "2026-07-27",
    "confidence": "reported",
    "votes_yes_no_abstain": {
     "BPC-157": "8-6-1 recommended",
     "KPV": "8-6-1 recommended",
     "TB-500": "8-6-1 recommended",
     "MOTs-c": "7-5-2 recommended",
     "Emideltide (DSIP)": "6-7-1 not recommended",
     "Epitalon": "7-4-1 recommended",
     "Semax": "8-5-1 recommended"
    },
    "quote_next_meeting": "PCAC will further consider the additions of GHK-Cu, Dihexa acetate, Cathelicidin LL-37, PEG-MGF, and Melanotan II at a meeting to be held before the end of February 2027 (paraphrase of article text)"
   }
  },
  "wada_prohibited_list": {
   "url": "https://www.wada-ama.org/en/prohibited-list",
   "pdf_2026": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
   "list_in_force": "2026 Prohibited List (in force 1 January 2026); the online list page read on 2026-10-15 shows 2026 content (e.g. 'These substances are included in the 2026 Monitoring Program').",
   "quote_S0": "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use ... is prohibited at all times. This class covers many different substances including but not limited to BPC-157",
   "quote_S2_2_3": "growth hormone fragments, e.g. AOD-9604 and hGH 176-191",
   "quote_S2_2_4_ghrh": "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)",
   "quote_S2_2_4_ghs": "growth hormone secretagogues (GHS) and their mimetics [e.g. anamorelin, capromorelin, ibutamoren (MK-677), ipamorelin, lenomorelin (ghrelin), macimorelin and tabimorelin]",
   "quote_S2_3": "Thymosin-β4 and its derivatives e.g. TB-500",
   "quote_M2_2": "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations.",
   "quote_b12": "Vitamin B12 (cyanocobalamin) is not prohibited because the cobalt present does not have the same effects as elemental cobalt or cobalt salts.",
   "list_2027": {
    "status": "confirmed (first-party WADA PDFs read; details in wada-2027.json)",
    "url": "https://www.wada-ama.org/en/resources/2027-prohibited-list",
    "pdf": "https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf",
    "quote": "The 2027 List of Prohibited Substances and Methods was approved by WADA's Executive Committee (ExCo) during its meeting on 10 September 2026 and enters into force on 1 January 2027.",
    "note": "Peptide change: 'peptides' added to the S0 examples; WADA note: 'for clarity, peptides are now named as examples in this section.' S2 peptide entries unchanged. Semaglutide and tirzepatide remain on the Monitoring Program, not prohibited."
   }
  }
 },
 "substances": [
  {
   "name": "BPC-157",
   "fda_503a_status": "Not in any 503A interim category as of the May 14, 2026 categories PDF. Formerly 503A category 2; listed by FDA under 'Bulk drug substances nominated but withdrawn' (page current as of 04/22/2026). Not on the 503A bulks list. Removal from category 2 is not placement in category 1.",
   "fda_safety_text": "Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization.",
   "pcac_2025_2026": "Discussed at PCAC July 23, 2026 (use evaluated: ulcerative colitis). FDA staff proposed not adding it. Reported vote 8-6 (1 abstention) to recommend inclusion; advisory only, no FDA final action or Federal Register proposed rule found as of 2026-10-15.",
   "fda_approval": "Not approved. FDA briefing: 'There is no approved product containing BPC-157-related BDSs in any country at this time' (https://www.fda.gov/media/193343/download).",
   "wada_2026": "S0 Non-approved substances (named explicitly), prohibited at all times.",
   "fda_warning_letters_2026": "None found naming BPC-157 in 2026 FDA warning letters reviewed (Gram Peptides 721806, Pink Pony Peptides 721088, Wholesale Peptide 729447, and the five Aug 24, 2026 letters).",
   "sources": [
    "https://www.fda.gov/media/94155/download?attachment",
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
    "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "TB-500 (thymosin beta-4 fragment LKKTETQ)",
   "fda_503a_status": "Not in any 503A interim category as of May 14, 2026. Listed by FDA as 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' under nominated but withdrawn (formerly category 2).",
   "fda_safety_text": "FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment.",
   "pcac_2025_2026": "Discussed at PCAC July 23, 2026 (use: wound healing). FDA staff: 'we propose not adding TB-500 (free base) or TB-500 acetate to the 503A Bulks List.' Reported vote 8-6 (1 abstention) to recommend.",
   "fda_approval": "Not approved.",
   "wada_2026": "S2.3 Growth factors: 'Thymosin-β4 and its derivatives e.g. TB-500'; prohibited at all times.",
   "fda_warning_letters_2026": "None found naming TB-500.",
   "sources": [
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
    "https://www.fda.gov/media/193349/download",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "GHK-Cu",
   "fda_503a_status": "Split by route. Non-injectable: 503A category 1 ('GHK-Cu (except for injectable routes of administration)' listed in category 1, May 14, 2026 PDF; briefly removed April 22, 2026 and added back after a May 5, 2026 clarification). Injectable: listed under 'nominated but withdrawn' (formerly category 2), not in any category.",
   "fda_safety_text": "Compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities.",
   "pcac_2025_2026": "FDA '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.' Not voted in July 2026.",
   "fda_approval": "No FDA-approved drug product (none found).",
   "wada_2026": "Not named on the 2026 list text read; no classification found.",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/media/94155/download?attachment",
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"
   ]
  },
  {
   "name": "CJC-1295",
   "fda_503a_status": "Not in any 503A interim category; listed under nominated but withdrawn (formerly category 2).",
   "fda_safety_text": "FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.",
   "pcac_2025_2026": "Not on the July 23-24, 2026 PCAC agenda; no PCAC date found.",
   "fda_approval": "Not approved.",
   "wada_2026": "S2.2.4 Growth hormone releasing factors (GHRH analogues, named explicitly).",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "Ipamorelin (acetate)",
   "fda_503a_status": "503A: not in any category; listed under nominated but withdrawn. 503B: still category 2 (added September 29, 2023) - FDA notes it 'also appears in the table above because it is in category 2 under the 503B interim policy'.",
   "fda_safety_text": "A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility.",
   "pcac_2025_2026": "Not on July 2026 PCAC agenda.",
   "fda_approval": "Not approved.",
   "wada_2026": "S2.2.4 growth hormone secretagogues (named explicitly).",
   "fda_warning_letters_2026": "Named in two Aug 24, 2026 letters as part of tesamorelin/ipamorelin blends: NuScience Peptides LLC 733652 ('Tesamorelin Ipamorelin Blend') and Royal Peptides LLC 734884 ('BIMORELIN is a cutting-edge dual peptide blend combining Tesamorelin (10mg) and Ipamorelin (3mg)').",
   "sources": [
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
    "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026",
    "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"
   ]
  },
  {
   "name": "AOD-9604",
   "fda_503a_status": "Not in any 503A interim category; listed under nominated but withdrawn (formerly category 2).",
   "fda_safety_text": "FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.",
   "pcac_2025_2026": "Not on July 2026 PCAC agenda.",
   "fda_approval": "Not approved.",
   "wada_2026": "S2.2.3 'growth hormone fragments, e.g. AOD-9604 and hGH 176-191'.",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "Sermorelin (acetate)",
   "fda_503a_status": "Not listed in any 503A interim category (May 14, 2026 PDF). It is the active ingredient of the formerly approved GEREF; FDA determined GEREF was not withdrawn for safety or effectiveness reasons (78 FR 14096, March 4, 2013). Whether this makes it compoundable under 503A as a component of an approved drug is a legal interpretation not stated by FDA on the pages read.",
   "quote": "FDA has determined under § 314.161 that GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn for reasons of safety or effectiveness.",
   "pcac_2025_2026": "None found.",
   "fda_approval": "No currently marketed FDA-approved sermorelin product found; GEREF (NDA 20-443, NDA 19-863) discontinued.",
   "wada_2026": "S2.2.4 GHRH analogues (named explicitly).",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf",
    "https://www.fda.gov/media/94155/download?attachment",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "Tesamorelin",
   "fda_503a_status": "Not in 503A interim categories. FDA-approved product exists; Drugs@FDA states: 'This Former NDA Was Deemed To Be a BLA on March 23, 2020' (BLA 022505).",
   "fda_approval": "Approved. EGRIFTA WR label (supplement S-020 approved 03/25/2025): 'EGRIFTA WR is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.' Limitations: 'Not indicated for weight loss management.' Dose: '1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously once daily.' 'EGRIFTA WR and EGRIFTA SV are not substitutable.' Initial U.S. Approval: 2010.",
   "pcac_2025_2026": "None found.",
   "wada_2026": "S2.2.4 GHRH analogues (named explicitly).",
   "fda_warning_letters_2026": "Named as unapproved new drug in all five Aug 24, 2026 'research use only' seller letters: Peptide Partners LLC 735063, Peak Performance Peptides 735127, Royal Peptides LLC 734884, NuScience Peptides LLC 733652, TXP Innovations LLC dba Tex Peptides 735067.",
   "sources": [
    "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf",
    "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "NAD+ (nicotinamide adenine dinucleotide)",
   "fda_503a_status": "503A category 1: 'Nicotinamide Adenine Dinucleotide (NAD)' and 'Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)'. Note: 'Beta-Nicotinamide Adenine Dinucleotide' appears in category 3.",
   "pcac_2025_2026": "None found.",
   "fda_approval": "No FDA-approved NAD+ drug product found.",
   "wada_2026": "Not named. IV infusions/injections over 100 mL per 12 hours are prohibited method M2.2 (relevant to NAD+ IV drips).",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/media/94155/download?attachment",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  },
  {
   "name": "Glutathione",
   "fda_503a_status": "503A category 1 ('Glutathione').",
   "pcac_2025_2026": "None found.",
   "fda_approval": "No FDA-approved glutathione drug product found.",
   "wada_2026": "Not named; M2.2 IV volume rule applies to infusions.",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/media/94155/download?attachment"
   ]
  },
  {
   "name": "L-carnitine (levocarnitine) / acetyl-L-carnitine",
   "fda_503a_status": "Levocarnitine is the active ingredient of FDA-approved CARNITOR (Drugs@FDA NDA 020182: 'CARNITOR LEVOCARNITINE INJECTABLE;INJECTION Prescription'). Acetyl-L-carnitine is a separate substance listed in 503A category 1 ('Acetyl L Carnitine/Acetyl-L- carnitine Hydrochloride').",
   "pcac_2025_2026": "None found.",
   "fda_approval": "Levocarnitine injection approved (CARNITOR, NDA 020182).",
   "wada_2026": "Not named; M2.2 IV volume rule applies.",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020182",
    "https://www.fda.gov/media/94155/download?attachment"
   ]
  },
  {
   "name": "Methylcobalamin / MIC-B12 injections",
   "fda_503a_status": "Methylcobalamin is in 503A category 1 ('Methylcobalamin'). Cyanocobalamin (the form in FDA-approved B12 injections) is not a bulks-list question. MIC (methionine, inositol, choline) components: 'Choline Chloride' appears in category 1; methionine and inositol were not checked in this session.",
   "pcac_2025_2026": "None found.",
   "fda_approval": "No FDA-approved methylcobalamin injection found in this session.",
   "wada_2026": "WADA Q&A: 'Vitamin B12 (cyanocobalamin) is not prohibited because the cobalt present does not have the same effects as elemental cobalt or cobalt salts.' M2.2 IV volume rule applies to infusions.",
   "fda_warning_letters_2026": "None found.",
   "sources": [
    "https://www.fda.gov/media/94155/download?attachment",
    "https://www.wada-ama.org/en/prohibited-list"
   ]
  }
 ],
 "news": [
  {
   "date": "2026-07-23",
   "title": "FDA advisory committee reviews seven peptides; votes to recommend six for the 503A bulks list",
   "summary": "FDA's Pharmacy Compounding Advisory Committee met July 23-24, 2026 to consider BPC-157, KPV, TB-500, MOTs-C, emideltide (DSIP), Semax and Epitalon for the 503A bulks list. FDA staff briefing documents proposed not adding BPC-157 or TB-500. Law-firm coverage reports the committee voted to recommend six of the seven (BPC-157, KPV and TB-500 each 8-6) and voted against emideltide (6-7).",
   "what_it_means_for_patients": "A committee vote is advice, not approval. None of these peptides is FDA-approved, and none was added to the 503A bulks list or category 1 as of October 15, 2026, so a legal compounded prescription is still not established.",
   "source_url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
   "secondary_url": "https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/",
   "publisher": "U.S. FDA (meeting); McDermott Will & Schulte (vote counts)",
   "confidence": "confirmed (meeting and agenda); reported (vote counts)"
  },
  {
   "date": "2026-08-01",
   "title": "Louisiana peptide law (SB 253, Act 374) takes effect",
   "summary": "Louisiana SB 253, 'PUBLIC HEALTH: Provides relative to peptides', was signed by the governor as Act 374 (May 22) with an effective date of August 1, 2026. Secondary summaries say it bars state licensing boards from prohibiting prescribers from providing peptides shipped from FDA-registered 503B outsourcers or 503A pharmacies that comply with federal law.",
   "what_it_means_for_patients": "It protects Louisiana clinicians from state board action, but it does not change federal compounding status; a pharmacy must still comply with section 503A or 503B.",
   "source_url": "https://www.legis.la.gov/legis/BillInfo.aspx?i=250428",
   "publisher": "Louisiana State Legislature",
   "confidence": "confirmed (status and effective date); reported (content summary)"
  },
  {
   "date": "2026-08-24",
   "title": "FDA warns five more 'research use only' peptide sellers",
   "summary": "FDA's CDER issued warning letters dated August 24, 2026 to Peptide Partners, Peak Performance Peptides, Royal Peptides, NuScience Peptides and Tex Peptides after July 2026 website reviews. The letters call semaglutide, tirzepatide, retatrutide, tesamorelin, SS-31, PT-141 and blends unapproved new drugs, and treat the bacteriostatic water sold alongside them as a drug. FDA states that 'research use only' labels did not change its conclusion because the websites showed the products were intended for human use.",
   "what_it_means_for_patients": "Peptides bought from 'research' websites are not legal prescription drugs, regardless of the disclaimer, and have no FDA oversight of quality or sterility.",
   "source_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026",
   "publisher": "U.S. FDA",
   "confidence": "confirmed"
  },
  {
   "date": "2026-10-07",
   "title": "Report: administration drafting temporary stopgap to allow some restricted peptides",
   "summary": "The Washington Post (Rachel Roubein), republished by the Anchorage Daily News on October 8, reported that the administration is drafting plans to allow temporary sale of previously restricted peptides through compounding pharmacies while new rules are written. The report cites two unnamed sources and says it 'was not immediately clear which peptides' would be included and 'timing was unclear'. HHS did not comment.",
   "what_it_means_for_patients": "Nothing changed on that date. Until a policy is published, peptides such as BPC-157 remain outside FDA's compounding categories.",
   "source_url": "https://www.adn.com/nation-world/2026/10/07/the-trump-administration-is-paving-way-for-temporary-sale-of-some-unapproved-peptides/",
   "publisher": "The Washington Post via Anchorage Daily News",
   "confidence": "reported"
  },
  {
   "date": "2026-10-15",
   "date_note": "OIRA received the submission 10/14/2026; press reports published 2026-10-15",
   "title": "HHS/FDA send 'interim access policy' for compounded peptides to White House review",
   "summary": "Reuters reported that HHS and FDA submitted an 'interim access policy for compounding using certain peptides' for White House review, according to a filing on the Office of Management and Budget website. 'The filing does not provide any details of the policy.' Citing two people, the AP said it would let pharmacies make some popular peptides, including BPC-157.",
   "what_it_means_for_patients": "This is a step toward a possible temporary enforcement policy, not a published rule. Which peptides, under what conditions, and when are all unknown. The OIRA record shows only the title, with no policy text.",
   "source_url": "https://www.reginfo.gov/public/do/eoDetails?rrid=1568964",
   "oira_record": "RIN 0910-ZD94; Received Date 10/14/2026; Title 'Interim Access Policy for Compounding Using Certain Peptides'; Agency HHS / FDA; Stage Notice; Economically Significant No; status Pending Review (see interim-peptide-policy.json)",
   "secondary_url": "https://www.yahoo.com/news/politics/articles/us-fda-takes-step-change-213124893.html",
   "publisher": "OMB/OIRA reginfo.gov (filing); Reuters via Yahoo News (reporting)",
   "confidence": "confirmed (OIRA filing exists); reported (content, including BPC-157)"
  }
 ],
 "warning_letters_2026": [
  {
   "firm": "Gram Peptides",
   "number": "721806",
   "date": "2026-03-31",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026",
   "products_named": [
    "retatrutide",
    "tirzepatide"
   ]
  },
  {
   "firm": "Lovega LLC dba Pink Pony Peptides",
   "number": "721088",
   "date": "2026-03-31",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026",
   "products_named": [
    "tirzepatide",
    "retatrutide"
   ]
  },
  {
   "firm": "Wholesale Peptide",
   "number": "729447",
   "date": "2026-06-17",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026",
   "products_named": [
    "Prostamax",
    "Gonadorelin"
   ],
   "quote": "Violations were identified and documented during a review of your website https://www.wholesalepeptide.com in May 2026. Based on our review, “Prostamax” and “Gonadorelin” are unapproved new drugs"
  },
  {
   "firm": "Peptide Partners LLC",
   "number": "735063",
   "date": "2026-08-24",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026",
   "products_named": [
    "semaglutide",
    "tirzepatide",
    "retatrutide",
    "SS-31 (elamipretide)",
    "tesamorelin",
    "PT-141 (bremelanotide)",
    "bacteriostatic water"
   ]
  },
  {
   "firm": "Peak Performance Peptides",
   "number": "735127",
   "date": "2026-08-24",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026",
   "products_named": [
    "Bac water",
    "GLP-3R (retatrutide)",
    "semaglutide",
    "SS-31",
    "PT-141",
    "tesamorelin"
   ]
  },
  {
   "firm": "Royal Peptides LLC",
   "number": "734884",
   "date": "2026-08-24",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026",
   "products_named": [
    "tirzepatide",
    "semaglutide",
    "retatrutide",
    "SS-31 (elamipretide)",
    "PT-141",
    "tesamorelin",
    "BIMORELIN (tesamorelin + ipamorelin)"
   ],
   "quote": "Despite statements on your product labeling marketing your products “for research use only” and “not for human or animal consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use."
  },
  {
   "firm": "NuScience Peptides LLC",
   "number": "733652",
   "date": "2026-08-24",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026",
   "products_named": [
    "tirzepatide",
    "semaglutide",
    "retatrutide",
    "survodutide",
    "mazdutide",
    "PT-141 (bremelanotide)",
    "tesamorelin",
    "tesamorelin ipamorelin blend",
    "bacteriostatic water"
   ]
  },
  {
   "firm": "TXP Innovations LLC dba Tex Peptides",
   "number": "735067",
   "date": "2026-08-24",
   "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026",
   "products_named": [
    "semaglutide",
    "tirzepatide",
    "retatrutide",
    "SS-31 (elamipretide)",
    "tesamorelin",
    "PT-141 (bremelanotide)",
    "bacteriostatic water"
   ]
  }
 ]
}