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5 November 2026 · Actualizado November 2026 · 13 min read

Hormone Optimization in a Telehealth Practice: Eight Questions on the DEA Rule, Labs and Consent

Telehealth testosterone prescribing in 2026: the DEA rule through 31 December, the two guidelines that set labs, licensure and consent, in eight questions.

Hormone OptimizationTelehealthTestosteroneDEA Telemedicine Rule503A CompoundingLaboratory MonitoringAdvertising CompliancePractitioner Guides
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Fuentes citadas

A hormone optimization telehealth practice is built around one date and one guideline: the DEA telemedicine flexibilities that allow a controlled substance such as testosterone to be prescribed without a prior in-person evaluation run through 31 December 2026 under the fourth temporary extension at 90 FR 61301 [4], and the Endocrine Society guideline sets the diagnosis on two fasting morning total testosterone measurements and a monitoring plan after initiation [1]. Jesse and colleagues compared three direct-to-consumer testosterone platforms with the AUA guideline in 2022 and reported that evaluation and follow-up practices were similar to the guideline while twelve months of intramuscular testosterone cost $1,586 to $4,200 through the platforms [3].

An owner or medical director adding hormone optimization to a telehealth practice meets eight questions in turn: the DEA frame, Schedule III logistics, the monitoring points, the compounded-versus-approved record, thyroid and DHEA sources, consent and labs across states, licensure, and advertising. ExaVeyra Sciences is a supplier; the hormone optimization line is compounded by our 503A pharmacy partner against a patient-specific prescription, and where a controlled substance is prescribed our 503A pharmacy partner dispenses it under its own DEA registration.

31 Dec 2026
End date of the fourth temporary extension of the DEA telemedicine flexibilities, 90 FR 61301 (DEA and HHS 2025)
5,200+
Men followed for major adverse cardiovascular outcomes in the TRAVERSE postmarketing trial (FDA 2026)
10
compounding pharmacies whose testosterone gels and creams were tested in two blinded batches against approved products (Grober 2015)

Regulatory status

Testosterone is a Schedule III controlled substance under 21 CFR 1308.13, and FDA-approved testosterone products are approved only for men who lack or have low testosterone with an associated medical condition [5]. Compounded hormone preparations are not FDA-approved, and section 503A conditions the exemption on a valid patient-specific prescription [18]. As of 4 November 2026 the DEA flexibilities run through 31 December 2026 and the special registration rule proposed at 90 FR 6541 had not been finalized [4]. Which preparation reaches which patient, and under which rule, is decided by the licensed practitioner and the dispensing pharmacy.

1. Under which DEA rule will the practice prescribe a controlled substance by telemedicine after 31 December 2026?

The Ryan Haight Act, as the DEA summarizes it in the rule text, allows remote prescribing of a controlled substance only after at least one in-person medical evaluation, subject to exceptions [4]. The COVID-19 flexibilities set that requirement aside, and the fourth temporary extension published on 31 December 2025 keeps them in force from 1 January 2026 through 31 December 2026 [4].

The permanent frame remains a proposal. The DEA published Special Registrations for Telemedicine and Limited State Telemedicine Registrations at 90 FR 6541 on 17 January 2025, with three registration types and comments that closed on 18 March 2025, and as of 4 November 2026 no final rule had appeared in the Federal Register [4]. Mooney and colleagues described in 2025 how the temporary rule and state licensing changes together produced telemedicine-only prescribing companies, and how improper prescribing has drawn board sanctions and criminal liability [4].

A documented answer is a written contingency: how the practice will handle existing testosterone patients and new ones if the flexibilities lapse, whether an in-person evaluation network exists in each state, and who tracks Docket DEA-407. Cummins and colleagues surveyed 115 telemental health prescribers in 2025 and reported that Schedule III was among the schedules they rated safest to prescribe remotely, with 14.8 to 19.1 percent by schedule saying they could rarely or never do so safely [16].

2. Who holds the DEA registration, and how is a Schedule III prescription dispensed to a patient in another state?

Testosterone and the other anabolic steroids sit in Schedule III at 21 CFR 1308.13(f) [5]. In a telehealth model the prescriber holds the registration that authorizes the prescription, and the dispensing pharmacy holds its own. Where a controlled substance is prescribed through the ExaVeyra formulary, our 503A pharmacy partner dispenses it under its own DEA registration, and the prescription fills only into a state where the pharmacy holds a nonresident license.

State law adds its own layer. Florida’s telehealth statute limits Schedule II prescribing by telehealth to listed circumstances, a reminder that each patient state has its own controlled-substance rules for remote prescribing [15]. A documented answer lists, for each state served, the prescriber’s DEA authority and state controlled-substance registration where required, the prescription monitoring program check, and the pharmacy’s license.

3. Which monitoring points from the Endocrine Society and AUA guidelines will the chart reproduce?

The Endocrine Society guideline recommends making a diagnosis only in men with symptoms and signs consistent with testosterone deficiency and unequivocally and consistently low fasting morning total testosterone, measured with an accurate assay and confirmed on repeat [1]. It recommends against starting in men planning near-term fertility or with listed conditions, including a prostate-specific antigen above stated thresholds, and recommends a monitoring plan after initiation [1].

The AUA guideline reaches the same operating conclusion: the authors concluded that care should center on accurate assessment of total testosterone, symptoms and signs, and proper on-treatment monitoring [2]. Jesse and colleagues reported that the three platforms they reviewed largely followed the AUA guideline for evaluation and follow-up, which shows the standard is attainable remotely when the lab logistics are solved [3].

QuestionWhy it mattersWhat a documented answer looks like
1. DEA rule after 31 December 2026Flexibilities expire; the special registration rule is still a proposal [4]A written contingency with an in-person evaluation network per state and a docket watch
2. Registration and dispensingTestosterone is Schedule III; each state adds its own remote prescribing limits [5, 15]Per state: prescriber authority, PMP check, pharmacy license, dispensing record
3. Guideline monitoring pointsTwo morning measurements, exclusion conditions, monitoring after initiation [1, 2]A protocol that names each lab, interval and action threshold
4. Compounded versus approvedNASEM and ACOG place approved products first [7, 8]A chart line stating why an approved product was unsuitable
5. Thyroid and DHEA sourcesGuidelines set the laboratory follow-up [11, 12, 13]Each prescription documented against its guideline
6. Consent and labs across statesStandard of care is the same as in person [15]A lab network per state, a consent that names compounding risks, a refill rule
7. Licensure by patient stateThe patient’s location governs [14, 15]A license matrix enforced by the platform
8. AdvertisingFTC requires competent and reliable evidence [17]A dated review of every public page

4. Why was a compounded preparation chosen over an FDA-approved product for this patient?

FDA-approved testosterone formulations include a topical gel, a transdermal patch, a buccal system and an injection, and FDA describes them as approved only for men with low testosterone and an associated medical condition [5]. For menopausal hormone therapy, FDA asked application holders in November 2025 to remove the boxed warning language on cardiovascular disease, breast cancer and probable dementia, retained the endometrial cancer warning for systemic estrogen-alone products, and approved labeling changes for six products on 12 February 2026 [6].

The National Academies report commissioned by FDA found a lack of rigorous evidence of safety and effectiveness for compounded bioidentical hormone therapy and recommended limiting use to patients who cannot use an approved product [7]. ACOG’s 2023 clinical consensus states that compounded preparations should not be prescribed routinely when approved formulations exist, and that patients should be counseled on the lack of FDA approval and the risks specific to compounding [8].

Grober and colleagues analyzed compounded testosterone from ten pharmacies in 2015 and reported that only 50 percent in one batch and 30 percent in the second were within 20 percent of the prescribed concentration, while the approved products were consistent [9]. A documented answer is one chart line per patient stating why the approved product was unsuitable, plus the pharmacy’s potency documentation for the preparation chosen; the supply chain post linked below sets out what that documentation contains.

5. Which guideline sources will thyroid and DHEA prescriptions be documented against?

The American Thyroid Association task force guideline reviewed the goals of levothyroxine therapy, the sources of dissatisfaction with it and the evidence on alternatives including combination therapy, and set its answers out as graded recommendations [11]. A T4/T3 prescription in a telehealth program is documented against that guideline, with the laboratory follow-up it describes scheduled through the practice’s lab network.

For DHEA the Endocrine Society adrenal insufficiency guideline is the society reference in which replacement is discussed with a trial period and laboratory follow-up [12]. Sultana and colleagues reviewed the randomized trials of DHEA and cognition in postmenopausal women in 2023 and reported that the only positive result came from a four-week crossover study of 24 women, so claims beyond laboratory replacement lack trial support [13].

  • Testosterone: fasting morning total testosterone twice before diagnosis, the exclusion checks, and the monitoring after initiation the Endocrine Society and AUA guidelines describe [1, 2]
  • T4/T3: the thyroid function follow-up described in the American Thyroid Association guideline, with the rationale for any combination prescription recorded [11]
  • DHEA: the baseline and follow-up laboratory values described in the Endocrine Society adrenal guideline [12]
  • Menopausal regimens: periodic reevaluation of benefits and risks as the 2022 Menopause Society statement describes [10]

6. Several questions remain open in the published evidence

A telehealth hormone program that states the limits of the evidence in its consent and its marketing is better placed with a board and with its patients. The points below set out what the evidence does not yet show.

  • Compounded hormone outcomes: the National Academies found that information on safety and effectiveness came mostly from low quality data [7], and ACOG calls for long-term randomized trials against approved products [8].
  • Compounded potency: Grober and colleagues found one product with essentially no testosterone and wide variability within and between pharmacies [9]; no comparable study of a telehealth-dispensed cohort was located.
  • Telehealth outcomes: Jesse and colleagues reviewed three platforms’ websites, not patient outcomes, and the authors noted that limitation [3].
  • DHEA: trial support for cognitive claims is limited to one four-week crossover study of 24 women [13].
  • The DEA frame: the special registration rule remains a proposal as of 4 November 2026, so no permanent standard for remote controlled-substance prescribing exists to design against [4].
  • Menopausal therapy labeling: the February 2026 approvals cover six products, and FDA’s pages do not address compounded preparations [6].

The Medical Board of California states that physicians retain the same responsibilities for informed consent and privacy whether care is delivered in person or by telehealth, and Florida’s statute holds a telehealth provider to the same practice act [15]. For a hormone program the consent carries two extra elements: that the preparation is compounded and not FDA-approved, and the risks specific to compounding that ACOG asks clinicians to explain [8].

The laboratory side decides whether the guideline monitoring in question 3 is real. A documented answer names the draw network in each state, the fasting morning instruction given to the patient, the interval between draws, the person who reviews each result before a refill, and the record of that review. Jesse and colleagues’ cost comparison is a reminder to state the laboratory fees to the patient alongside the visit fee [3].

8. In which states is each prescriber licensed, and what may the practice say in its advertising?

The patient’s location governs the visit, and the Interstate Medical Licensure Compact counts 44 member states plus two territories as of 31 October 2026 [14]. Vakkalanka and colleagues analyzed 141 million Medicare encounters and reported that Compact participation was associated with more out-of-state telehealth, while concluding that interstate barriers still exist [14]; Koumpias and colleagues reported that licensure waivers were followed by large increases in out-of-state tele-mental health care among 2,037,977 insured people [15].

The Federal Trade Commission’s Health Products Compliance Guidance requires competent and reliable scientific evidence for health benefit claims, generally randomized, controlled human clinical testing, and bars testimonials that convey claims the advertiser could not make directly [17]. The 2022 Menopause Society statement’s language of individualized therapy with periodic reevaluation is a model for public copy that describes a process and promises no result [10].

A documented answer is a license matrix per prescriber per state, a platform that confirms the patient’s location before each visit, and a dated review of every public page against the FTC standard and the board rules of each state served. A practice holding those three records can show any board how its hormone line was built.

A documented program opens the verified account

A telehealth practice that answers the eight questions in writing holds a DEA contingency, a per-state dispensing record, a guideline-based monitoring protocol, a compounded-versus-approved chart line, a lab network, a license matrix and reviewed public pages. ExaVeyra Sciences connects that practice with our 503A pharmacy partner, which compounds the hormone optimization line against a patient-specific prescription, holds nonresident licenses in 33 jurisdictions including Puerto Rico, and dispenses any controlled substance under its own DEA registration.

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. Practices that document the program before the first prescription are well placed for whatever the special registration rule finally says, because the records it is likely to ask for already exist.

Aviso Educativo: 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.

Referencias

  1. 1.Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. PMID 29562364. doi:10.1210/jc.2018-00229Clinical practice guideline developed with the GRADE approach by a task force of ten content experts and a methodologist, with two commissioned systematic reviews. Carries in this article: the guideline recommends a diagnosis only in men with symptoms and unequivocally low fasting morning total testosterone confirmed on repeat, sets out the conditions in which it recommends against starting, and recommends a monitoring plan after initiation, the points a telehealth chart must reproduce. Disclosure: Endocrine Society guideline; cosponsor review noted in the record.
  2. 2.Mulhall JP, Trost LW, Brannigan RE, Kurtz EG, Redmon JB, Chiles KA, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423-432. PMID 29601923. doi:10.1016/j.juro.2018.03.115American Urological Association guideline built on a systematic review. Carries in this article: the authors concluded that care should center on accurate assessment of total testosterone, symptoms and signs, and proper on-treatment monitoring, the second guideline a telehealth protocol is usually written against. Disclosure: AUA guideline panel.
  3. 3.Jesse E, Sellke N, Rivero MJ, Muncey W, Ghayda RA, Loeb A, et al. Practice Comparison and Cost Analysis of Direct-to-Consumer Telemedicine Platforms Offering Testosterone Therapy. J Sex Med. 2022;19(11):1608-1615. PMID 35690575. doi:10.1016/j.jsxm.2022.03.609Observational website analysis of three direct-to-consumer telemedicine platforms compared with the AUA guideline and with a tertiary center’s cost estimator. Carries in this article: the authors reported that initial evaluation and follow-up practices were similar to the guideline, while twelve months of intramuscular testosterone cost $1,586 to $4,200 through the platforms against $134 to $1,333 at the tertiary center under various insurance models. Disclosure: none stated in the PubMed record.
  4. 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 Drug Enforcement Administration, Special Registrations for Telemedicine and Limited State Telemedicine Registrations, proposed rule, 90 FR 6541, 17 January 2025, comments closed 18 March 2025, Docket DEA-407; 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.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrationsLegal analysis of telemedicine prescribing law, 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 improper prescribing has drawn board sanctions and criminal liability. The fourth extension carries the agency’s summary of the Ryan Haight Act and the extension of the flexibilities through 31 December 2026; the proposed rule carries the three proposed special registration types. As of 4 November 2026 no final special registration rule had been published in the Federal Register. Disclosure: none stated in the PubMed record.
  5. 5.U.S. Food and Drug Administration. Testosterone Information. Content current as of 06/23/2026; verified 4 November 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information ; with 21 CFR 1308.13(f), Schedule III, anabolic steroids (Code of Federal Regulations, 2025 edition, govinfo). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol9/xml/CFR-2025-title21-vol9-sec1308-13.xmlAgency page. Carries in this article: testosterone products are FDA-approved only for men who lack or have low testosterone with an associated medical condition; the TRAVERSE postmarketing trial tracked major adverse cardiovascular outcomes in more than 5,200 men and the agency describes the June 2023 result as showing no meaningful difference; and in June 2026 the agency revised prescribing information, including removal of the age-related hypogonadism limitation of use and revised blood pressure and prostate safety information. The regulation places anabolic steroids, including testosterone, in Schedule III.
  6. 6.U.S. Food and Drug Administration. FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies. 10 November 2025; content current as of 02/12/2026; verified 4 November 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations ; with FDA Approves Labeling Changes to Menopausal Hormone Therapy Products, press announcement, 12 February 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-productsAgency statement and press announcement. Carries in this article: after an expert panel on 17 July 2025 the agency asked application holders to remove the boxed warning language on cardiovascular disease, breast cancer and probable dementia and to retain the endometrial cancer boxed warning for systemic estrogen-alone products, and on 12 February 2026 it approved labeling changes for six menopausal hormone therapy products. Neither page mentions compounded products.
  7. 7.National Academies of Sciences, Engineering, and Medicine. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press; 2020. doi:10.17226/25791 ; with U.S. Food and Drug Administration, National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded "Bioidentical" Hormone Therapy. Content current as of 07/02/2019; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/national-academies-science-engineering-and-medicine-nasem-study-clinical-utility-treating-patientsConsensus study report commissioned by FDA, 336 pages, released 1 July 2020. Carries in this article: the FDA page states that the Academies found a lack of rigorous evidence of safety and effectiveness, that the available information came mostly from low quality data, and that widespread use poses a public health concern; the report recommended that use be limited to patients who cannot use an approved product. Disclosure: FDA-sponsored study.
  8. 8.American College of Obstetricians and Gynecologists’ Committee on Clinical Consensus-Gynecology. Compounded Bioidentical Menopausal Hormone Therapy: ACOG Clinical Consensus No. 6. Obstet Gynecol. 2023;142(5):1266-1273. PMID 37856860. doi:10.1097/AOG.0000000000005395Clinical consensus document. Carries in this article: the committee states that compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist, that clinicians should counsel patients on the lack of FDA approval and the risks specific to compounding, and that long-term randomized trials against approved products are needed. Disclosure: ACOG committee document.
  9. 9.Grober ED, Garbens A, Božović A, Kulasingam V, Fanipour M, Diamandis EP. Accuracy of testosterone concentrations in compounded testosterone products. J Sex Med. 2015;12(6):1381-1388. PMID 25963000. doi:10.1111/jsm.12898Blinded laboratory analysis of two batches of compounded testosterone gel or cream from ten pharmacies against two approved products. Carries in this article: only 50 percent of pharmacies in batch one and 30 percent in batch two were within 20 percent of the prescribed concentration, one product contained essentially no testosterone, and the approved products were consistent, the reason the pharmacy’s potency documentation is a question in its own right. Disclosure: non-US government research support listed in the PubMed record.
  10. 10.“The 2022 Hormone Therapy Position Statement of The North American Menopause Society” Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794. PMID 35797481. doi:10.1097/GME.0000000000002028Society position statement. Carries in this article: the panel states that hormone therapy should be individualized using the best available evidence, with periodic reevaluation of benefits and risks, and that the benefit-risk ratio is favorable for women younger than 60 or within ten years of menopause onset without contraindications, the reevaluation cadence a telehealth program needs to schedule. Disclosure: society document.
  11. 11.Jonklaas J, Bianco AC, Bauer AJ, Burman KD, Cappola AR, Celi FS, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. PMID 25266247. PMC4267409. doi:10.1089/thy.2014.0028Task force guideline with graded recommendations using the American College of Physicians system. Carries in this article: the task force reviewed the goals of levothyroxine therapy, the sources of patient dissatisfaction and the evidence on alternatives including combination therapy, and set its answers out as formal recommendations, the reference against which a T4/T3 prescription and its laboratory follow-up are documented. Disclosure: American Thyroid Association guideline.
  12. 12.Bornstein SR, Allolio B, Arlt W, Barthel A, Don-Wauchope A, Hammer GD, et al. Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(2):364-389. PMID 26760044. PMC4880116. doi:10.1210/jc.2015-1710Endocrine Society clinical practice guideline. Carries in this article: the guideline is the society reference in which DHEA replacement is discussed, with a trial period and laboratory follow-up described, so a DHEA prescription in a telehealth program is documented against a guideline. Disclosure: Endocrine Society guideline.
  13. 13.Sultana F, Davis SR, Islam RM. Effect of dehydroepiandrosterone therapy on cognitive performance among postmenopausal women: a systematic review of randomized clinical trial data. Menopause. 2023;30(11):1167-1173. PMID 37788418. doi:10.1097/GME.0000000000002251Systematic review of randomized trials in postmenopausal women to November 2022. Carries in this article: the authors reported that the only positive cognitive outcome came from a four-week crossover study of 24 women, so DHEA claims beyond laboratory replacement lack trial support. Disclosure: non-US government research support listed in the PubMed record.
  14. 14.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 141,199,029 Medicare outpatient encounters, 2018 to 2022. Carries in this article: Compact participation before the pandemic was associated with higher out-of-state telehealth (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 boards. Disclosure: academic authors; no industry funding stated.
  15. 15.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), and Medical Board of California, Telehealth; 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://www.mbc.ca.gov/Resources/Medical-Resources/Telehealth.aspxClaims analysis of 2,037,977 insured people across three border metropolitan areas. Carries in this article: licensure and relationship waivers were followed by large increases in out-of-state tele-mental health care. The Florida statute carries the standard-of-care clause, the clause removing the physical examination requirement when the telehealth evaluation is sufficient to diagnose, and the limit on Schedule II prescribing by telehealth; the California page carries the in-state license requirement and the same-standard statement. Disclosure: ICMJE forms filed.
  16. 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 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, with Schedule III among the schedules rated safest. Disclosure: none stated in the PubMed record.
  17. 17.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 competent and reliable scientific evidence, generally randomized, controlled human clinical testing for health-related benefits, and testimonials may not convey claims that would be deceptive if made directly.
  18. 18.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 a valid patient-specific prescription; outsourcing facilities are subject to CGMP and may distribute on a provider order that is not for an identified patient; and compounded drugs are not FDA-approved.

Frequently Asked Questions

Can you prescribe testosterone via telehealth?
Under the fourth temporary extension of the DEA telemedicine flexibilities, a registered practitioner may prescribe a controlled substance such as testosterone by telemedicine without a prior in-person evaluation through 31 December 2026, subject to state law [4]. The prescriber needs a license in the patient’s state, and the pharmacy must be licensed to ship there [15].
What are the TRT telehealth rules in 2026?
Three layers apply: the DEA flexibilities running through 31 December 2026 with the special registration rule still a proposal [4], state telehealth statutes that hold the visit to the in-person standard of care [15], and the Endocrine Society and AUA guidelines on diagnosis and monitoring [1, 2]. Testosterone remains Schedule III under 21 CFR 1308.13 [5].
What is the DEA telemedicine controlled substances rule?
The DEA and HHS published the Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications at 90 FR 61301 on 31 December 2025, effective 1 January through 31 December 2026 [4]. The permanent framework, Special Registrations for Telemedicine, was proposed at 90 FR 6541 in January 2025 and had not been finalized as of 4 November 2026 [4].
What are the telehealth requirements for a hormone program?
A license in the patient’s state, a visit that meets the in-person standard of care, informed consent that names compounding where a compounded preparation is used, a laboratory network for the guideline monitoring, a DEA-registered prescriber and pharmacy for any controlled substance, and advertising that meets the FTC evidence standard [15, 17]. ACOG asks that compounded preparations follow approved products [8].
What labs do telehealth hormone programs need?
The Endocrine Society guideline recommends fasting morning total testosterone measured with an accurate assay and confirmed on repeat before diagnosis, exclusion checks including prostate-specific antigen thresholds, and a monitoring plan after initiation [1]. Thyroid and DHEA prescriptions follow their own guideline schedules [11, 12]. The telehealth question is the draw network in each state and who reviews each result.
Is testosterone a controlled substance?
Yes. Anabolic steroids, including testosterone, are listed in Schedule III at 21 CFR 1308.13(f), and FDA states that approved testosterone products are indicated only for men who lack or have low testosterone with an associated medical condition [5]. Where a controlled substance is prescribed, our 503A pharmacy partner dispenses it under its own DEA registration.
Are compounded bioidentical hormones FDA approved?
No. Compounded drugs are not FDA-approved [18]. The National Academies report commissioned by FDA found a lack of rigorous evidence of safety and effectiveness and recommended limiting use to patients who cannot use an approved product [7], and ACOG states that compounded menopausal hormone therapy should not be prescribed routinely when approved formulations exist [8].
Did FDA remove the boxed warning from hormone therapy?
In November 2025 FDA asked application holders to remove the boxed warning language on cardiovascular disease, breast cancer and probable dementia from menopausal hormone therapy labels while retaining the endometrial cancer warning for systemic estrogen-alone products, and on 12 February 2026 it approved labeling changes for six products [6]. The pages do not address compounded preparations.
How accurate are compounded testosterone preparations?
Grober and colleagues tested two batches from ten compounding pharmacies in 2015 and reported that only 50 percent and 30 percent of pharmacies were within 20 percent of the prescribed concentration, with one product containing essentially no testosterone, while approved products were consistent [9]. The pharmacy’s lot-specific potency documentation is therefore a question to ask before the first prescription.
How do direct-to-consumer testosterone platforms compare with guidelines?
Jesse and colleagues compared three platforms with the AUA guideline in 2022 and reported that initial evaluation and follow-up were similar to the guideline, while twelve months of intramuscular testosterone cost $1,586 to $4,200 through the platforms against $134 to $1,333 at a tertiary center under various insurance models [3]. The review covered platform websites, and patient outcomes were outside its scope.

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