Adding peptides to a telehealth practice turns on nine questions, and the first is where each patient sits when the visit happens, because the Interstate Medical Licensure Compact now counts 44 member states plus two territories and 59 boards, yet a prescription still has to be written under a license valid in the patient’s state and filled by a pharmacy licensed to ship into it [1]. A 2025 Medicare analysis of 141 million outpatient encounters found that Compact participation was associated with more out-of-state telehealth, while the authors concluded that interstate barriers still exist [1].
A telehealth owner or medical director usually meets the questions in this order: licensure, the remote standard of care, which compounds have an open 503A route as of 4 November 2026, the pharmacy’s nonresident licenses, refrigerated shipping, labs and follow-up, advertising and the platform. ExaVeyra Sciences is a supplier; the compounds named here are compounded by our 503A pharmacy partner against a patient-specific prescription, and every prescribing decision belongs to the licensed practitioner.
Regulatory status
Compounded drugs are not FDA-approved, and section 503A conditions the exemption on a valid patient-specific prescription [8]. As of 4 November 2026 the codified 503A bulks list names six substances and no peptide [20]; FDA’s safety-risks page carries BPC-157, CJC-1295, ipamorelin and injectable GHK-Cu with stated concerns or as withdrawn nominations, sermorelin appears nowhere on it [5, 6], and on 30 October 2026 HHS published a draft interim enforcement discretion policy covering six peptides under ten conditions, open for comment to 13 November 2026 [19]. The Ryan Haight Act governs controlled substances and does not reach a non-controlled peptide, so the DEA telemedicine flexibilities extended through 31 December 2026 are relevant only when a controlled substance is prescribed alongside the program [4]. Which compound reaches which patient is decided by the licensed practitioner and the dispensing pharmacy.
1. In which states is each prescriber licensed, and where will the patient be at the time of the visit?
The patient’s location at the moment of the encounter decides which medical board governs the visit. The Medical Board of California states that physicians using telehealth to care for patients located in California must be licensed in California, and that the standard of care is the same whether the patient is seen in person or through telehealth [3]. Florida reaches the same destination by statute and adds a registration route for out-of-state providers [2].
The Compact offers qualifying physicians an expedited path to additional full licenses, and its Commission reports 44 member states plus two territories as of 31 October 2026 [1]. Koumpias and colleagues studied 2,037,977 insured people across three border metropolitan areas and reported that pandemic-era licensure waivers were followed by large increases in out-of-state tele-mental health care, concluding that Compact participation may offer broader access than emergency waivers [2].
A documented answer is a license matrix: each prescriber, each state, the license number, its expiry and whether it came through the Compact or a direct application. The platform then enforces the matrix by asking the patient to confirm the state they are in before each visit and routing the visit only to a prescriber licensed there.
2. What standard of care applies to a prescription issued without an in-person visit?
State law answers this directly in several states. Florida’s telehealth statute states that a provider who conducts a patient evaluation sufficient to diagnose is not required to conduct a physical examination before using telehealth, and holds the provider to the same practice act as in-person care [2]. California’s board page states that physicians retain the same responsibilities for informed consent and privacy regardless of modality [3].
The published record of direct-to-consumer services shows why boards write it that way. Resneck and colleagues submitted structured cases to 16 telemedicine websites and apps in 2016 and reported that only 26 percent disclosed licensure, that prescriptions were ordered in 65 percent of diagnosed cases, and that relevant adverse effects were discussed in a minority [3]. Hariton and Tracy proposed in 2019 that companies supplying prescription-only medicines observe evidence-based prescribing guidelines and coordinate with existing clinicians [15].
A documented answer is a written visit protocol: the history elements collected, the labs reviewed before a first prescription, the consent language, and the record that shows the evaluation was sufficient for the diagnosis made. Mooney and colleagues described in 2025 how board sanctions and, in two cases, criminal liability followed improper prescribing through telemedicine-only platforms [4].
3. Does the Ryan Haight Act or the DEA telemedicine rule apply to the compounds in the program?
The Ryan Haight Act defines a valid prescription for a controlled substance and, subject to exceptions, requires at least one in-person medical evaluation before a practitioner prescribes a controlled substance remotely [4]. The statute addresses controlled substances only, so a non-controlled peptide such as sermorelin, NAD+ or glutathione is outside its reach, and the state practice act and the standard of care in question 2 govern instead [4].
Where a telehealth program also prescribes a controlled substance, the current frame is the fourth temporary extension of the COVID-19 telemedicine flexibilities, published at 90 FR 61301 and effective 1 January 2026 through 31 December 2026 [4]. Cummins and colleagues surveyed 115 telemental health prescribers in 2025 and reported that 14.8 to 19.1 percent, depending on schedule, felt they could rarely or never safely prescribe controlled substances remotely [16].
A documented answer names each compound in the program, states whether it is scheduled, and records the rule relied on for any scheduled item. Where a controlled substance is prescribed, our 503A pharmacy partner dispenses it under its own DEA registration, and the practice keeps its own registration and state authority current for the states it prescribes into.
4. Which peptides have an open 503A route as of 4 November 2026, and which are reserved for IND-authorized trials?
FDA’s 503A bulks page, current as of 14 May 2026, states that the agency does not intend to place substances nominated on or after 7 January 2025 into the interim categories, and that category 1 substances may remain within the interim enforcement policy until the agency decides on their inclusion [5]. The safety-risks page, current as of 22 April 2026, lists BPC-157, CJC-1295, ipamorelin and GHK-Cu for injectable routes with immunogenicity and impurity rationales, and the nominators withdrew several of those nominations in April 2026 [6].
The sequence since then matters for a telehealth owner reading older material. In April 2026 the nominators withdrew CJC-1295, ipamorelin, BPC-157, TB-500 and injectable GHK-Cu from category 2 [6]; on 14 May 2026 the non-injectable GHK-Cu entry returned to category 1 [5]; the Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026 to discuss BPC-157, KPV, TB-500, MOTs-C, emideltide, semax and epitalon related substances, and its recommendations are advice to the agency [7]. The codified bulks list at 21 CFR 216.23 still names six substances and no peptide [20].
On 30 October 2026 HHS published a notice of availability for a draft Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, at 91 FR 68526, with comments open to 13 November 2026 [19]. The notice states that HHS does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding under section 503A with a peptide in the policy’s Appendix A, that the policy is interim while the bulks list is developed through rulemaking, and that the draft establishes no rights and is not binding on HHS or the public [19].
The six peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, each limited to the forms and routes in the policy’s Appendix B, none of which lists an intravenous route [19]. The ten conditions, as the policy document describes them, include a single active ingredient from Appendix A, a bulk substance from an FDA-registered original manufacturer with a certificate of analysis, serious adverse event reporting to MedWatch and the states involved, a label stating the product is a compounded drug not for resale, oral bioavailability documentation for oral forms, a 510(k)-cleared syringe as the only co-packaged device, and a valid patient-specific prescription under the other requirements of the Act [19]. Outsourcing facilities under 503B are not addressed, and GHK-Cu, CJC-1295, ipamorelin, emideltide and sermorelin are not on the list [19].
| Compound | Position on federal pages, 4 November 2026 | Supply framing | Source |
|---|---|---|---|
| Sermorelin | No entry on the safety-risks page and not on the HHS list; compounded for years as a formerly approved active ingredient | Compounded by our 503A pharmacy partner against a patient-specific prescription | [6, 17, 19] |
| NAD+, glutathione, methylcobalamin, LDN | No entry on the safety-risks page | Compounded by our 503A pharmacy partner against a patient-specific prescription | [6] |
| GHK-Cu (topical) | Injectable entry withdrawn in April 2026; non-injectable entry in category 1 since 14 May 2026; not on the HHS list | Available as topical 503A preparations compounded to prescription | [5, 6, 14, 19] |
| BPC-157, TB-500, MOTS-c, epitalon, KPV, semax | Named in the HHS draft interim policy of 30 October 2026 under ten conditions and route limits; absent from 21 CFR 216.23 | Offered for IND-authorized clinical trials through our pharmacy partner, with the sponsor’s IND number, sponsor details and protocol confirmed before any supply | [7, 11, 19, 20] |
| CJC-1295, ipamorelin | Withdrawn from category 2 in April 2026; not on the HHS list | Offered for IND-authorized clinical trials through our pharmacy partner, with the sponsor’s IND number, sponsor details and protocol confirmed before any supply | [6, 19] |
| Semaglutide, tirzepatide | Compounded versions are not FDA-approved; 990 and more than 730 adverse event reports respectively as of 31 May 2026 | Read the GLP-1 note linked below before building a program | [9] |
Several of the HHS conditions describe the prescriber’s side of the record: the patient-specific prescription, the route matched to Appendix B, and the adverse event reporting path, which is why a telehealth practice should ask how each will be documented across state lines [19]. A documented answer is the pharmacy’s written statement, dated, of which compounds it will prepare for the practice’s states, under which 503A route or policy each qualifies, and with the federal pages as read that day attached. The 503A primer linked below explains the three routes in detail.
5. In which states does the pharmacy hold a nonresident license, and what happens to a prescription for a patient elsewhere?
A compounded prescription can only be filled into a state where the pharmacy is licensed to ship, so a telehealth practice with patients in twenty states needs a pharmacy licensed in those twenty. Our 503A pharmacy partner holds nonresident licenses in 33 jurisdictions including Puerto Rico, and availability in a destination state is confirmed before a first prescription is filled.
The FDA laws page describes the other half of the map: outsourcing facilities under section 503B may distribute in response to a provider order that is not for an identified patient, while 503A compounding is conditioned on patient-specific prescriptions [8]. A telehealth model ships to the patient, which places it naturally on the 503A side.
A documented answer is the pharmacy’s license list by state with license numbers and expiry dates, reconciled against the practice’s own license matrix from question 1. States that appear in one list and not the other are the states where the program is not offered until the gap closes.
6. How are refrigerated preparations shipped to a patient’s home, and what records prove the cold chain?
Many compounded peptide preparations are refrigerated after dispensing, and the patient’s doorstep replaces the clinic freezer. Chandler and colleagues tested insulin under simulated summer and winter transit in 2008 and found that potency held within USP limits in both insulated and noninsulated packaging, a model of the shipping validation a pharmacy should be able to show, together with its excursion procedure [18].
A documented answer from the pharmacy covers four items: the packaging validation, the carrier service level and transit time, the beyond-use date assigned under the USP chapter the preparation was made under, and the instruction sheet the patient receives on arrival. The practice’s own record notes the date of dispensing and the patient’s confirmation of receipt.
7. Which labs and follow-up records will the chart carry for each compound?
Sigalos and Pastuszak reviewed the human studies of growth hormone secretagogues in 2018 and reported that few long-term controlled studies exist, that the compounds were well tolerated in available studies with some concern for blood glucose, and that long-term safety had not been established [13]. That review is the reason a secretagogue chart usually carries a baseline and follow-up metabolic panel chosen by the prescriber.
For a telehealth practice the logistics matter as much as the panel. A documented answer names the laboratory network used in each state, the interval between visits, how results are reviewed before a refill, and who contacts the patient when a result is out of range. Hariton and Tracy’s proposed guidelines for direct-to-consumer services place coordination with the patient’s other clinicians on the same list [15].
- Baseline labs ordered and reviewed before the first prescription, with the ordering prescriber named
- The follow-up interval and the panel repeated at each interval, written into the protocol per compound
- A refill rule: no renewal without a reviewed result and a documented visit
- A named person who contacts the patient about an out-of-range result, and the record of that contact
8. Several questions remain open in the published evidence
The compound-level evidence is uneven, and a telehealth practice that states the limits in its own materials is better placed with a board and with its patients. The points below set out what the evidence does not yet show.
- Human safety data for most unapproved peptides are scarce: Mendias and Awan reported in 2026 that favorable results come largely from animal models and that social media amplifies a placebo effect [11].
- BPC-157 remains preclinical: Vasireddi and colleagues found 35 preclinical studies and one retrospective series of 12 patients, with no clinical safety data [12].
- Secretagogue outcomes are short term: Sigalos and Pastuszak reported few long-term, rigorously controlled studies and no established long-term safety [13].
- GHK-Cu human trials are small and cosmetic: Najafi and colleagues described the human literature as thin, with most trials conducted on facial creams, and noted commercial interests in about 35 percent of the primary literature [14].
- Telehealth-specific outcomes are unstudied: none of the located studies compares peptide program outcomes by visit modality or by state licensure model.
- Compounded GLP-1 preparations carry an adverse event signal: FDA recorded 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide as of 31 May 2026, some requiring hospitalization [9].
9. What may the practice say in its advertising, and what must the platform record?
The Federal Trade Commission’s Health Products Compliance Guidance states that health benefit and safety claims require competent and reliable scientific evidence, which for health-related benefits will generally need to be randomized, controlled human clinical testing, and that testimonials may not convey claims that would be deceptive if made directly [10]. For a peptide line whose human trials are few, that standard leaves room to describe the compounds, the pharmacy route and the visit process, and little room for outcome promises.
State boards reach advertising through the practice act as well. The Florida statute holds a registered out-of-state telehealth provider to the same standards of practice as a Florida licensee, and discipline may include suspension or revocation of the registration [2]. A documented answer is a review of every public page against the FTC standard and the board rules of each state served, with the reviewer and date recorded.
The platform question completes the set. The record for each encounter should show the patient’s stated location, the prescriber’s license in that state, the identity check, the consent, the evaluation, the prescription transmitted electronically to a named pharmacy, and the follow-up schedule. A practice that can print that record for any patient has answered the first eight questions in writing.
| Question | Why it matters | What a documented answer looks like |
|---|---|---|
| 1. Licensure by patient state | The patient’s location governs the visit [1, 3] | A license matrix per prescriber per state, enforced by the platform |
| 2. Remote standard of care | Boards hold telehealth to the in-person standard [2, 3] | A written visit protocol and a chart that shows a sufficient evaluation |
| 3. Controlled-substance rules | Ryan Haight reaches controlled substances only; flexibilities run through 31 December 2026 [4] | Each compound listed with its schedule status and the rule relied on |
| 4. 503A route per compound | Category status, the HHS interim policy and 21 CFR 216.23 fix which compounds a pharmacy will prepare [5, 6, 7, 19, 20] | The pharmacy’s dated statement per compound with the federal pages as read |
| 5. Nonresident pharmacy licenses | A prescription fills only into a licensed state [8] | The pharmacy’s license list reconciled with the practice’s matrix |
| 6. Cold chain to the home | Transit excursions are documented in the literature [18] | Packaging validation, transit time, beyond-use date and patient instructions |
| 7. Labs and follow-up | Secretagogue reviews report short-term data only [13] | Baseline and interval panels, a refill rule and a named follow-up owner |
| 8. Evidence limits | Most unapproved peptides lack human safety data [11, 12, 14] | A limits statement in consent and marketing |
| 9. Advertising and platform | FTC requires competent and reliable evidence for health claims [10] | A dated review of public copy and a printable encounter record |
A documented program opens the verified account
A telehealth practice that answers the nine questions in writing has a license matrix, a visit protocol, a compound list with its 503A status, a pharmacy license list, a shipping record, a lab schedule and a reviewed set of public pages. ExaVeyra Sciences connects that practice with our 503A pharmacy partner, which compounds the formulary against a patient-specific prescription and holds nonresident licenses in 33 jurisdictions including Puerto Rico.
Anyone may ask the scientific team a question or apply without an NPI, and NPI verification, which takes one to three business days, gives access to the practitioner portal, product documentation and pricing. Telehealth practices that build the record first tend to add states and compounds smoothly afterward, with each new state entering the matrix the day its license arrives.
Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
References
- 1.Vakkalanka P, Young T, Carter KD, Ullrich F, Ward MM, Mohr NM. Permissive Telehealth State Licensure Policies Are Associated with Increased Telehealth Utilization. Telemed J E Health. 2025;31(9):1096-1105. PMID 40354295. doi:10.1089/tmj.2025.0089 ; with Interstate Medical Licensure Compact Commission, official site (imlcc.com), snapshot statistics updated 2 November 2026 with information as of 31 October 2026; verified 4 November 2026. https://imlcc.com/Quasi-experimental analysis of a 5 percent Medicare fee-for-service sample, 141,199,029 outpatient encounters for 1,682,501 beneficiaries, 2018 to 2022. Carries in this article: Compact participation before the pandemic was associated with higher out-of-state telehealth use (adjusted odds ratio 2.24), and the authors concluded that interstate barriers still exist. The Commission page carries the count of 44 member states plus 2 US territories and 59 licensing boards, and the statement that imlcc.com is the Commission’s only official website. Disclosure: academic authors (University of Iowa); no industry funding stated in the PubMed record.
- 2.Koumpias AM, Fleming O, Lin LA. Association of licensure and relationship requirement waivers with out-of-state tele-mental health care, 2019-2021. Health Aff Sch. 2024;2(4):qxae026. PMID 38756180. PMC11034529. doi:10.1093/haschl/qxae026 ; with Florida Statutes section 456.47, Use of telehealth to provide services (2026 Florida Statutes, Online Sunshine), and Florida Department of Health, Out-of-State Telehealth Provider Registration; both verified 4 November 2026. https://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0456/Sections/0456.47.html ; https://flhealthsource.gov/telehealth/Claims analysis of 2,037,977 commercially insured people in three metropolitan areas straddling state borders, January 2019 to December 2021. Carries in this article: waivers of in-state licensure and of the prior relationship requirement were followed by large relative increases in out-of-state tele-mental health care, and the authors concluded that compact participation may provide broader access than emergency waivers. The Florida statute carries the standard-of-care clause, the clause that a telehealth evaluation sufficient to diagnose removes the physical examination requirement, and the out-of-state registration route. Disclosure: ICMJE forms filed as supplementary material.
- 3.Resneck JS Jr, Abrouk M, Steuer M, Tam A, Yen A, Lee I, et al. Choice, Transparency, Coordination, and Quality Among Direct-to-Consumer Telemedicine Websites and Apps Treating Skin Disease. JAMA Dermatol. 2016;152(7):768-775. PMID 27180232. doi:10.1001/jamadermatol.2016.1774 ; with Medical Board of California, Telehealth (Business and Professions Code section 2290.5 summary); verified 4 November 2026. https://www.mbc.ca.gov/Resources/Medical-Resources/Telehealth.aspxSimulated-patient study of 62 encounters across 16 direct-to-consumer telemedicine websites and apps serving California residents, February to March 2016. Carries in this article: only 26 percent disclosed clinician licensure information, some used physicians without California licenses, and prescriptions were ordered in 65 percent of diagnosed cases. The Board page carries the statements that physicians serving patients located in California must hold a California license and that the standard of care is the same as in person. Disclosure: non-US government research support listed in the PubMed record.
- 4.Mooney BS, Drabiak K, Fogel S. Risks of Improper Stimulant Prescribing With Telemedicine-Only Platforms. J Leg Med. 2025;44(3-4):231-249. PMID 41719473. doi:10.1080/01947648.2026.2629369 ; with Drug Enforcement Administration and Department of Health and Human Services, Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 90 FR 61301, 31 December 2025, effective 1 January 2026 through 31 December 2026, Docket DEA-407; and 21 U.S.C. 829(e), Controlled substances dispensed by means of the Internet (U.S. Code 2024 edition, govinfo); both verified 4 November 2026. https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled ; https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap13-subchapI-partC-sec829.htmLegal analysis of the laws governing telemedicine prescribing, state licensing and prescription monitoring programs, with two criminal cases. Carries in this article: the DEA temporary rule and state licensing changes are the two shifts behind telemedicine-only companies, and board sanctions and criminal liability follow improper prescribing. The rule text carries the agency’s own summary of the Ryan Haight Act (remote prescribing of controlled substances only after at least one in-person medical evaluation, subject to exceptions) and the extension of the flexibilities through 31 December 2026. The statute defines a valid prescription for controlled substances and applies to controlled substances only. Disclosure: none stated in the PubMed record.
- 5.U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 05/14/2026; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-actAgency page describing the 503A bulks list, the three interim categories and the January 2025 guidance revision. Carries in this article: the agency states it does not intend to place substances nominated on or after 7 January 2025 into the categories, and category 1 substances may remain within the interim enforcement policy until the agency decides on their inclusion or removes them on new safety information.
- 6.U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. Content current as of 04/22/2026; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risksAgency page listing substances placed in category 2 with the stated rationale, and a list of substances previously in category 2 that their nominators withdrew. Carries in this article: BPC-157, CJC-1295, ipamorelin and GHK-Cu for injectable routes appear with immunogenicity and impurity rationales, and sermorelin does not appear anywhere on the page as read on 4 November 2026.
- 7.U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee, Docket FDA-2025-N-6895. Content current as of 08/06/2026; verified 4 November 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026Meeting page with the agenda. Carries in this article: BPC-157, KPV, TB-500 and MOTs-C related substances were discussed on 23 July and emideltide, semax and epitalon related substances on 24 July, each for a named proposed use. The page posts logistics and briefing materials; a committee recommendation is advice to the agency, and a substance’s status is whatever the lists say until a rule places it on the 503A bulks list.
- 8.U.S. Food and Drug Administration. Human Drug Compounding Laws. Content current as of 12/17/2024; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-lawsAgency page summarizing sections 503A and 503B. Carries in this article: one condition of 503A is that drugs are compounded on receipt of valid patient-specific prescriptions; outsourcing facilities are subject to CGMP, are inspected on a risk-based schedule and may distribute in response to a health care provider order that is not for an identified patient; and compounded drugs are not FDA-approved.
- 9.U.S. Food and Drug Administration. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Content current as of 10/01/2026; verified 4 November 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-lossAgency statement. Carries in this article: compounded drugs are not FDA approved and are not reviewed for safety, effectiveness or quality before marketing, and as of 31 May 2026 the agency had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide, some requiring hospitalization, with dosing errors among the causes the agency describes.
- 10.Federal Trade Commission. Health Products Compliance Guidance. December 2022 (updates and replaces the 1998 Dietary Supplements advertising guide). Verified 4 November 2026. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidanceAgency guidance under Sections 5 and 12 of the FTC Act. Carries in this article: health benefit and safety claims require substantiation in the form of competent and reliable scientific evidence, which for health-related benefits will generally need to be randomized, controlled human clinical testing, and testimonials or expert endorsements may not convey claims that would be deceptive if made directly.
- 11.Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. PMID 41966639. doi:10.1007/s40279-026-02437-0Narrative review of approved and unapproved peptides marketed direct to patients, including BPC-157, CJC-1295, GHK-Cu, ipamorelin, MOTS-c, sermorelin, tesamorelin and TB-500. Carries in this article: the authors reported that many unapproved peptides show favorable tissue outcomes in animal models while rigorous human safety data are scarce, and that social media amplifies a placebo effect. Disclosure: one author receives consulting fees from a device company for unrelated work.
- 12.Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, et al. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. 2025;21(4):485-495. PMID 40756949. PMC12313605. doi:10.1177/15563316251355551Systematic review of PubMed, Cochrane and Embase to June 2024; 36 included studies, 35 preclinical and 1 clinical (a retrospective series of 12 patients). Carries in this article: the authors found no clinical safety data and rated the body of evidence level IV and V, the reason BPC-157 sits in the animal-only column of the evidence table. Disclosure: academic authors (Case Western Reserve); none stated in the PubMed record.
- 13.Sigalos JT, Pastuszak AW. The Safety and Efficacy of Growth Hormone Secretagogues. Sex Med Rev. 2018;6(1):45-53. PMID 28400207. PMC5632578. doi:10.1016/j.sxmr.2017.02.004Review of clinical studies of growth hormone secretagogues in human subjects. Carries in this article: the authors reported that few long-term, rigorously controlled studies exist, that available studies indicate the compounds are well tolerated with some concern for blood glucose, and that long-term safety including cancer incidence has not been established. Disclosure: NIH extramural support; the authors reported no conflicts of interest.
- 14.Najafi N, Maatouk H, Vardanyan KG, Vartanian KB, Agrawal DK. A Systematic Review of the Mechanisms and Therapeutic Applications of GHK-Cu (Glycyl-L-Histidyl-L-Lysine-Copper Complex) in Topical Microneedle Delivery: A Case for Expanded Clinical Trials. Arch Intern Med Res. 2026;9(3):269-293. PMID 42787770. PMC13604022. doi:10.26502/aimr.0255PRISMA-mapped systematic review of GHK-Cu literature 2005 to 2026; 1,247 records screened, 64 retained. Carries in this article: the authors described the human literature as thin, with most randomized trials small and conducted on facial cosmetic creams, and no adequately powered registered trial of microneedle delivery. Disclosure: the authors note that about 35 percent of the primary GHK-Cu literature involves authors with commercial interests in the peptide.
- 15.Hariton E, Tracy EE. Telemedicine Companies Providing Prescription-Only Medications: Pros, Cons, and Proposed Guidelines. Obstet Gynecol. 2019;134(5):941-945. PMID 31599848. doi:10.1097/AOG.0000000000003529Commentary with proposed guidelines for direct-to-consumer telehealth companies that supply prescription-only medications. Carries in this article: the authors proposed that such services observe evidence-based prescribing guidelines, coordinate with existing clinicians and keep care patient-centered, the frame used for the follow-up documentation question. Disclosure: none stated in the PubMed record.
- 16.Cummins MR, Ivanova J, Soni H, Robbins Z, Bunnell BE, López E, et al. Telemedicine Prescribing by US Mental Health Care Providers: National Cross-Sectional Survey. JMIR Form Res. 2025;9:e63251. PMID 40068126. PMC11939023. doi:10.2196/63251National cross-sectional survey of 115 US telemental health prescribers. Carries in this article: 84 percent strongly agreed they were comfortable prescribing by telemedicine, while 14.8 to 19.1 percent by schedule felt they could rarely or never safely prescribe controlled substances remotely, a reminder that the platform question and the controlled-substance question are separate. Disclosure: none stated in the PubMed record.
- 17.Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. PMID 18031173. doi:10.2165/00063030-199912020-00007Drug review from the period when sermorelin was an approved product. Carries in this article: the review described sermorelin as a growth hormone-releasing hormone analogue that had been studied in children with idiopathic growth hormone deficiency, the product history a telehealth prescriber should know before the compound is discussed. Disclosure: Adis drug evaluation.
- 18.Chandler C, Gryniewicz CM, Pringle T, Cunningham F. Insulin temperature and stability under simulated transit conditions. Am J Health Syst Pharm. 2008;65(10):953-963. PMID 18463345. doi:10.2146/ajhp070347Laboratory study of insulin shipped under simulated transit conditions, with temperature logging and stability testing. Carries in this article: regular, NPH and 70/30 insulin held potency within USP limits after 24 to 120 hours of simulated summer and winter transit in insulated and noninsulated packaging, a model of the shipping validation a pharmacy should be able to show for a refrigerated preparation shipped to a patient’s home. Disclosure: pharmacy service authors; none stated in the PubMed record.
- 19.U.S. Department of Health and Human Services, Office of the Secretary. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. 91 FR 68526-68527, 30 October 2026, Docket HHS-OASH-2026-0496, RIN 0910-ZD94; comments to 13 November 2026. Verified 4 November 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances ; policy document: https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdfFederal Register notice read in full on 4 November 2026. Carries in this article: the Secretary announced a draft interim policy under which HHS does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding under section 503A with a peptide bulk drug substance in the policy’s Appendix A (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500), subject to ten conditions, while the 503A bulks list is developed through rulemaking; the notice states that compounded drugs are not FDA-approved and that the draft policy establishes no rights and is not binding on HHS or the public. The policy document on hhs.gov returned HTTP 403 to automated retrieval on 4 and 5 November 2026, so the ten conditions are described in the body at the level on which two independent legal summaries agree, and the owner should read the appendix before this article ships.
- 20.21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (Code of Federal Regulations, 2025 edition, govinfo; final rule 84 FR 4710, 19 February 2019). Verified 4 November 2026. https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol4/xml/CFR-2025-title21-vol4-sec216-23.xml ; current text: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23The codified 503A bulks list. Carries in this article: paragraph (a) names six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide), paragraph (b) names four declined, and no peptide appears; paragraph (d) states that representing a compounded drug made with a listed substance as FDA approved or endorsed misbrands it.