BPC-157 503A September 29, 2023 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. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. Cathelicidin LL-37 503A September 29, 2023 Compounded drugs containing cathelicidin LL-37 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA lacks sufficient safety-related information regarding cathelicidin LL-37 to know whether the drug would cause harm when administered to humans. Nonclinical research findings suggest detrimental effects on male reproduction and that this drug can be protumorigenic in some tissues. Cesium chloride 503A July 30, 2018 The use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. Cesium chloride (CsCl) can cause irregular heartbeats, also called arrhythmias. There have been reports of humans experiencing serious heart problems after taking CsCl. CsCl is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart function.    Chloral hydrate 503B October 5, 2022 Chloral hydrate presents significant safety risks related to dosing errors, oversedation and other adverse events including death, especially in the pediatric population. Diethylstilbestrol 503B August 21, 2023 Diethylstilbestrol is associated with cancer of the breast in women who were exposed while pregnant and clear cell adenocarcinoma in the vagina and cervix of women who were exposed in utero. A positive association has been observed between exposure to diethylstilbestrol and cancer of the endometrium, and between in-utero exposure to diethylstilbestrol and squamous cell carcinoma of the cervix and cancer of the testis. Dihexa acetate 503A September 29, 2023 FDA has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration. FDA lacks important information regarding any safety issues raised by dihexa acetate, including whether it would cause harm if administered to humans. Domperidone 503A October 27, 2015 Domperidone is associated with a serious risk of life-threatening cardiac arrhythmias and sudden cardiac death in all populations, including healthy lactating women. Domperidone is transferred into human breast milk, but it is unknown to what extent domperidone in breast milk is absorbed by the breastfed infant and what the resulting drug levels and drug side effects in the exposed infant would be. Domperidone is available to treat certain gastrointestinal conditions that are refractory to standard treatment under an expanded access investigational new drug (IND) program. Edetate disodium (except for ophthalmic use) 503B October 12, 2022 Edetate disodium poses significant safety risks due to medical providers inadvertently interchanging edetate disodium with edetate calcium disodium. In a Federal Register notice published June 12, 2008, FDA withdrew “approval of one new drug application (NDA) and two abbreviated new drug applications (ANDAs) for edetate disodium injection.” The notice stated, “there have been cases where children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for indications other than those approved by FDA.” Emideltide (DSIP) 503A September 29, 2023 Compounded drugs containing emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified safety-related information regarding emideltide for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans. Epitalon 503A September 29, 2023 Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has not identified safety-related information regarding epitalon for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans. Germanium sesquioxide   503A June 9, 2016 Germanium sesquioxide is likely to be contaminated with highly toxic inorganic forms of germanium salts which can be toxic to the kidneys. Germanium has resulted in nephrotoxicity (kidney injury) and death, even at recommended use levels. GHK-Cu (for injectable routes of administration) 503A September 29, 2023 Compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. There are limited data in humans to inform safety-related considerations. Growth hormone releasing peptide-2 (GHRP-2) (for injectable and nasal routes of administration) 503B September 29, 2023 Compounded drugs containing GHRP-2 for injectable and nasal administration may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. GHRP-2 also contains an unnatural amino acid, which adds to the complexity of peptide characterization. FDA is aware of reports of serious adverse advents in patients who received GHRP-2, including increased insulin requirement to maintain the blood glucose level, death of critically ill study subjects, infection and pancreatitis, though causality has not been established. Growth hormone releasing peptide-6 (GHRP-6) 503B September 29, 2023 Compounded drugs containing GHRP-6 may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has identified limited safety-related information, but the available data reveal safety concerns including potential effect on cortisol and increase in blood glucose due to decreases in insulin sensitivity.  Ibutamoren mesylate 503A; 503B 503A: September 29, 2023
503B: December 29, 2022 Ibutamoren mesylate poses significant safety risks due to the potential for congestive heart failure in certain patients. The agency is aware of a randomized, placebo-controlled trial assessing ibutamoren mesylate for the treatment of patients recovering from hip fracture that “was terminated early due to a potential safety signal of congestive heart failure.” Ipamorelin acetate 503B September 29, 2023 Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans via those routes. Kisspeptin-10 503A September 29, 2023 Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. KPV 503A September 29, 2023 FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans. Melanotan II 503A September 29, 2023 Compounded drugs containing Melanotan II may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. Mechano growth factor pegylated (PEG-MGF) 503A September 29, 2023 Compounded drugs containing Mechano Growth Factor Pegylated (PEG-MGF) may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified any human exposure data on drug products containing PEG-MGF administered via any route of administration. FDA lacks important information regarding any safety issues raised by PEG-MGF, including whether it would cause harm if administered to humans. MOTs-C 503A September 29, 2023 Compounded drugs containing MOTs-C may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified, any human exposure data on drug products containing MOTs-C administered via any route of administration. FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans. Neomycin sulfate (all parenteral drug products containing neomycin sulfate except when used for ophthalmic or otic use or in combination with polymyxin B sulfate for irrigation of the intact bladder) 503B October 12, 2022 There is a significant safety risk that “systemic exposure to neomycin sulfate, whether resulting from intravenous or IM administration, or resulting from absorption after instillation in or irrigation of body cavities, structures or spaces, or from use in wet dressings may cause nephrotoxicity, irreversible ototoxicity (auditory and vestibular) and neuromuscular blockade which may result in muscular paralysis or respiratory failure.” Quinacrine hydrochloride for intrauterine administration 503A; 503B

503A: June 9, 2016
503B: June 7, 2021

Quinacrine HCl is a known mutagen (causes changes in the DNA of a cell) and is associated with serious adverse reactions such as aplastic anemia, hepatitis, severe dermatitis, exacerbation or worsening of psoriasis and psychosis. Safety risks associated with intrauterine administration of quinacrine HCl (e.g., for female sterilization) include increased risk for life-threatening reproductive tract malignancies. Semax (heptapeptide) 503A September 29, 2023 Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans. Thymosin beta-4, fragment (LKKTETQ) 503A September 29, 2023 Compounded drugs containing thymosin Beta-4, Fragment (LKKTETQ) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities. FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment. FDA lacks important information regarding any safety issues raised by this drug, including whether it would cause harm if administered to humans.     Tranilast 503B September 29, 2023 There is a potential risk of serious adverse events associated with systemic absorption of tranilast, including significantly elevated liver enzymes (liver injury), hematologic abnormalities (leukopenia, thrombocytopenia, anemia, hemolytic anemia) and renal failure, which are serious and potentially life threatening.

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