Regulatory status

FDA — research use only; no approval.

FDA — no approval; clinical development stopped after bleeding-related adverse events.

FDA — research use only; no approval.

FDA — research use only; no approval.

FDA — no approval; Phase 2 investigation for neuropathic and inflammatory conditions.

FDA — no approval; not on the 503A bulks list. Category 2 safety-concern listing 2023; July 2026 PCAC evaluation weighed against inclusion, final rule pending

FDA — research use only; no approval; 503A compounding is prohibited.

FDA — research use only; no approval; 503A compounding is prohibited.

FDA — no approval; a Phase 3 program is investigating this long-acting amylin analogue.

FDA — no approval; the fixed-dose combination remains in Phase 3 development.

FDA — research use only; no approval.

FDA — no drug approval; supplement or drug classification depends on the region.

FDA — no US approval; approvals in Austria, Russia, China and South Korea cover Alzheimer’s disease, post-stroke recovery and traumatic brain injury.

Austria — national approval for Alzheimer’s disease, recovery after stroke and traumatic brain injury; this does not establish EU-wide authorization.

FDA status: prescription compounding availability; this classification does not establish FDA drug approval. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — approved specifically for ovulation induction; endocrine and testosterone-related uses are off-label. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

US supplement classification for oral collagen peptides; this does not establish FDA drug approval. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA status: investigational prescription use for endocrine protocols; no FDA approval. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. Extreme caution applies because irreversible muscle growth and off-target effects remain concerns. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

US OTC cosmetic classification; cosmetic availability does not establish FDA approval as a drug. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — no approval; research use only. No 503A ban is recorded; affirmative compounding authorization remains unestablished.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — the combined preparation lacks approval and is barred from preparation by 503A compounding pharmacies.

FDA — no product approval is established here. The regulatory category is clinical and compoundable, with no 503A ban and telehealth availability.

FDA — approved diagnostic uses assess hypogonadotropic hypogonadism and pituitary-gonadal function; prescription compounding is available.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — approval applies to specific indications for prescription somatropin, including growth hormone deficiency and selected catabolic conditions. This approval does not establish anti-aging or performance regimens.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — no approval is established here; the regulatory category permits prescription compounding, with no 503A ban and telehealth availability.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA — experimental use only, without therapeutic approval. The regulatory record indicates no prescription requirement, no 503A ban and no applicable telehealth pathway.

FDA: no approval for human treatment; research use only. Preparation by 503A compounding pharmacies is prohibited. Telehealth is not applicable.

FDA: no approval for human treatment; research use only. No 503A ban is identified; compounding authorization remains unknown. Telehealth is available.

US regulatory context includes supplement and prescription forms. No specific FDA approval determination is established here. Telehealth is available. No 503A ban is identified, which does not establish compounding permission.

FDA: investigational; no approval for treatment. No 503A ban is identified; compounding authorization remains unknown. Telehealth is not applicable.

FDA approval covers prescription liraglutide products: Victoza for type 2 diabetes and Saxenda for obesity. Telehealth is available. No 503A ban is identified; that does not establish permission to compound.

FDA: no approval for human treatment; research use only. No 503A ban is identified; compounding authorization remains unknown. Telehealth is not applicable.

FDA approval is indication-specific in the afamelanotide context, with prescription requirements. This does not confer approval for non-indicated tanning. Telehealth is not applicable. No 503A ban is identified, without affirmative compounding authorization.

FDA: no approval for human treatment; research use only. Preparation by 503A compounding pharmacies is prohibited. Telehealth is not applicable.

FDA: no approval for human treatment; research use only. No 503A ban is identified; compounding authorization remains unknown. Telehealth is not applicable.

FDA: no approval for human treatment; research use only. No 503A ban is identified; compounding authorization remains unknown. Telehealth is not applicable.

FDA: no approval for human treatment; research use only. No 503A ban is identified; compounding authorization remains unknown. Telehealth is available.

US use includes supplements and clinical administration; a specific FDA approval determination is not established here. Telehealth is available. No 503A ban is identified, without affirmative compounding authorization.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — Pitocin is approved by prescription for induction of labor and treatment of bleeding after childbirth. Intranasal psychiatric and behavioral research is distinct from those approved indications.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — Oral Elmiron is a prescription treatment approved for bladder pain in interstitial cystitis. This approval is separate from experimental injectable or osteoarthritis applications.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — Prescription Vyleesi is approved for HSDD in premenopausal women. Bremelanotide cannot be prepared by pharmacies operating under section 503A.

FDA — Investigational Phase III drug without US approval. Lawful compounding is not available under sections 503A or 503B, and prescription access through telehealth is unavailable.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — Prescription approvals include Ozempic for type 2 diabetes (2017), Rybelsus as a daily oral product (2019), and Wegovy for chronic weight management (2021).

FDA — No US approval. Research use does not constitute approval for treatment in humans.

FDA — Geref (sermorelin acetate): NDA 20-443 (0.5 and 1.0 mg vials) for idiopathic growth hormone deficiency in children with growth failure, NDA 19-863 (0.05 mg ampoule) for evaluating pituitary growth-hormone secretion; discontinued 2008, approvals withdrawn 2009-06-18 (not for safety or effectiveness reasons)

FDA — SLU-PP-332 has no approved indication and remains a research compound. No prescription pathway is identified; telehealth prescribing is not applicable.

US cosmetic category — SNAP-8 is used in over-the-counter skin products, which does not establish FDA drug approval. A prescription is not required for this cosmetic use.

FDA — Forzinity (elamipretide) injection; accelerated approval 2025-09-19 for Barth syndrome in patients weighing at least 30 kg

FDA — TB-500 is unapproved for human treatment and cannot be prepared by 503A compounding pharmacies. Telehealth prescribing is not applicable.

FDA — TB-500 Fragment has no drug approval. Preparation by 503A compounding pharmacies is banned; no telehealth prescribing pathway applies.

FDA — Egrifta SV (tesamorelin) is a prescription GHRH analogue approved for reducing excess visceral abdominal fat in adults with HIV-associated lipodystrophy. Prescription access includes specialty pharmacies and telehealth.

US prescription compounding availability for immune support does not establish FDA approval. Thymosin alpha-1 has approvals in more than 40 countries for hepatitis-related and cancer-support uses, but specific EU, UK and UAE determinations are not established here. Telehealth access is available.

FDA — prescription tirzepatide is approved as Mounjaro for type 2 diabetes and as Zepbound for obesity, with an obstructive sleep apnea indication added in 2024. Telehealth prescribing is available.

US prescription compounding access is available, including telehealth; this is not an FDA approval determination for VIP. Its immune, vascular and airway applications remain subjects of clinical research.

FDA — the BPC-157/TB-500 fixed blend has no approval. Preparation through 503A compounding pharmacies is banned, and telehealth prescribing is not applicable.