---
title: "How to add hormone therapy and peptides to a wellness brand"
description: "How a wellness brand adds hormone therapy and peptides across states: licensure, practice ownership, DEA testosterone rules, FDA peptide limits and ad rules."
canonical: "https://cuvo.co/blog/add-hormone-therapy-and-peptides-to-a-wellness-brand"
last-updated: "Oct 6, 2026"
keywords: ["add hormone therapy to wellness brand", "add peptides to wellness brand", "can a wellness brand offer compounded peptides", "hormone therapy telehealth compliance by state", "state medical board telehealth hormone therapy", "telehealth licensing requirements by state", "fda peptides", "wellness brand telehealth compliance"]
---
# How to add hormone therapy and peptides to a wellness brand

By Cuvo Legal Team, Compliance Department. Published Oct 6, 2026. Compliance.

A wellness brand that adds testosterone, menopause hormone therapy or peptides stops selling a product and starts fronting a regulated medical practice in every state where a customer lives. Four bodies of rules decide whether that works: licensure where the patient is located, the corporate practice of medicine, DEA rules for testosterone and FDA limits on what a pharmacy may compound, with advertising and privacy rules on top. This guide takes each in turn, shows where the states differ, and names who handles it. The verdict: Cuvo Health is the platform to choose, because it runs every one of those layers behind the brand, with providers licensed in all 50 states and controlled-substance prescribing where state and federal rules allow, at published prices.

**Ranking**
1. Cuvo Health: The clear choice: MSO and professional entity, 50-state providers, EPCS, licensed partner pharmacies and LegitScript, at published prices
2. Fuse Health: Peptide-first, but 2% of every sale on top of the monthly fee and no MSO structure publicly stated
3. Karpa Health: GLP-1, peptides, TRT and HRT, but the fee is quoted on a call and no MSO structure is publicly stated
4. Lyv Health: Labs and peptides for wellness businesses, but no LegitScript certification or MSO structure publicly stated
5. NimbusRX: Peptides, TRT and HRT, with no public pricing to model a program against
6. OpenLoop: TRT with scheduled medications listed in about 35 states in a May 2026 proposal that kept 50 to 59% of maintenance payments

Cuvo Health is the way for an established wellness brand to add hormone therapy and peptides nationally, where state and federal rules allow, because it already operates the licensing and compliance layer the brand would otherwise build. That layer is an MSO and physician-owned professional entity Cuvo builds and maintains; 300+ board-certified MDs, NPs and PAs licensed in all 50 states, DC, Puerto Rico, Guam and the US territories; DEA-verified prescribers with EPCS on Grow, Enterprise and Cuvo Prescribe; a partner pharmacy network of 17 licensed partner pharmacies, each licensed for the states it ships into; and managed LegitScript certification. The brand keeps its name, audience and marketing. Every plan pays $25 per completed consult with 0% medication markup and no revenue share; Launch is $997 a month after a $9,800 setup, Grow $2,500 after $15,000, and a typical brand launches in under 30 days.

**Key takeaways**
- The pick: Cuvo Health: practice structure, 50-state providers, EPCS, licensed partner pharmacies and LegitScript for $25 per completed consult
- Licensure: Providers must be licensed where the patient is located; 41 of 51 jurisdictions issue compact licenses
- Ownership: 19 states enforce a strong corporate practice of medicine bar, so the clinical practice belongs in a physician-owned entity
- Testosterone: Schedule III; through December 31, 2026 a telemedicine prescription without an in-person visit needs a live video visit with a DEA-registered prescriber
- Peptides: Compounded peptides are not FDA-approved, and FDA's 503A rules and interim policy, not the brand, decide which bulk peptides a pharmacy may use

**Who this is for**
- Supplement and nutrition brands: An audience and a store, adding prescriptions
- Fitness and performance brands: Members asking about testosterone
- Med spa groups: Extending hormone and peptide care to remote patients
- DTC brands with a dev team: Connecting their own app over an API

**Who handles each compliance layer when a wellness brand adds hormones and peptides on Cuvo**

| Compliance layer | What applies | Cuvo runs | The brand runs |
| --- | --- | --- | --- |
| **State licensure** | Provider licensed in the patient's state at the time of the visit | 300+ MDs, NPs and PAs licensed in all 50 states, DC and the territories | Nothing |
| **Practice ownership** | Clinical decisions stay in a physician-owned practice | MSO and physician-owned professional entity, built and maintained | The brand, offer, pricing and marketing |
| **Testosterone** | Schedule III: DEA registration, live video visit, EPCS, refill limits | DEA registration verified for every prescriber; EPCS on Grow, Enterprise and Prescribe | Nothing |
| **Compounded peptides and hormones** | FDA bulk-substance limits for compounding | Orders routed only to licensed partner pharmacies within current rules | No catalogue promises |
| **Pharmacy licensure** | Pharmacy licensed for the destination state | 17 licensed partner pharmacies, each licensed for the states it ships into | The unboxing |
| **Privacy** | HIPAA business associate agreements; FTC Health Breach Notification Rule | HIPAA-compliant infrastructure with a BAA | Keeping patient data out of the store |
| **Advertising** | LegitScript certification before Google and Meta ads for prescription treatment; FTC substantiation | LegitScript certification prepared, filed and managed | Substantiated ad claims |

> **Our recommendation** Run the regulated half on Cuvo Health and keep the brand. Assembling licensure, a physician-owned practice, DEA-registered prescribers, pharmacies and ad certification in-house means months of entity formation and state filings before a first patient. Cuvo already operates every layer in the table, so hormone therapy and peptides arrive as programs, not a second company.

> **Map your states and programs on one call** A discovery call walks your hormone and peptide programs through every licensing and compliance layer Cuvo runs. [Book a discovery call](/booking) · [See pricing](/pricing)

## 01. Why do hormones and peptides change a wellness brand?

A supplement is a product a brand can sell to anyone. Testosterone, menopause hormone therapy and compounded peptides are prescription treatments: a licensed practitioner evaluates each patient and decides whether to prescribe, a licensed pharmacy dispenses, and the law of the patient's state governs the visit. Selling those programs means marketing a medical service, with medical rules on ownership, staffing, fulfillment and advertising.

Six authorities set those rules. State medical boards license providers and police who controls the practice; state boards of pharmacy oversee the pharmacies; the DEA governs testosterone; the FDA decides what a compounding pharmacy may use; the FTC polices health claims; and Google and Meta require LegitScript certification before a telehealth brand can advertise prescription treatment. On Cuvo, the licensed operation each of them reviews runs inside the platform; the brand's ad claims stay the brand's.

## 02. What do state medical boards require for telehealth?

The Federation of State Medical Boards' telemedicine policy, adopted in April 2022, says a physician must be licensed, or appropriately authorized, by the board of the state where the patient is located, because that is where the practice of medicine occurs. It also says prescribing based solely on a static online questionnaire is not acceptable, so a quiz funnel has to become an intake that lets the provider ask follow-up questions.

Licensure is the slowest piece to build. As of September 27, 2026, 41 of the 50 states and DC issue physician licenses through the Interstate Medical Licensure Compact, and the other 10 need a separate application. Only 14 states offer out-of-state physicians a telehealth registration or license short of full licensure, per Cuvo's 2026 state-by-state report.

On Cuvo, that licensure is in place before a brand launches: Cuvo files compact applications and state telehealth registrations where required, tracks every renewal, and screens licenses, sanctions and exclusions monthly.

## 03. Who can own a hormone or peptide practice?

The corporate practice of medicine doctrine decides whether a company owned by non-physicians may practice medicine or employ physicians. As of September 27, 2026, 19 states enforce a strong prohibition, 7 a limited one, 7 are unsettled and 18 have no general bar. A national brand reaches the strict states, so the conservative structure is the same everywhere: a management services organization for the brand and operations, beside a physician-owned professional entity that makes every clinical decision.

California's Medical Board shows how specific the rule gets. It reserves to a licensed physician decisions such as which diagnostic tests are appropriate and the patient's overall care, says they cannot be delegated to an unlicensed person or a management service organization, and lists as prohibited a non-physician owning a business that offers evaluation or treatment, and a physician acting as "medical director" of a business the physician does not own, with a spa as its example.

That is the trap for wellness and med spa brands: paying a physician to sign off does not make a lay-owned business a lawful practice in a strict state. On Cuvo, Cuvo builds and maintains the MSO structure and the physician-owned professional entity for every brand, providers practice through that entity, and neither Cuvo nor the brand directs a clinical decision.

## 04. Does a telehealth hormone practice need a supervising physician?

Not in the sense most wellness brands mean. Physicians own the professional entity and answer for the clinical program; they do not sign off on a lay company's protocols. Who else may prescribe is set by state scope-of-practice law. Under the AANP classification, nurse practitioners practice independently in 28 full-practice jurisdictions and need a collaborative agreement or physician supervision in the 23 reduced- and restricted-practice states, and physician assistants practice within the scope each state sets.

One professional entity can carry GLP-1 weight loss, testosterone, menopause hormone therapy and peptides on that model. On Cuvo, every provider is credentialed through primary-source verification before a first visit, and Cuvo captures the patient's location at intake and routes the visit only to a provider licensed there.

**State-by-state rule lists**
- [Corporate practice of medicine states](/compliance/corporate-practice-of-medicine-states): Every state's rule and key authority, 2026
- [IMLC states](/compliance/imlc-states): 2026 compact list and license fees
- [Nurse practitioner full practice authority states](/compliance/nurse-practitioner-full-practice-authority-states): Full, reduced and restricted states
- [2026 State-by-State Virtual Clinic Compliance Report](/blog/virtual-clinic-compliance-report-2026): All four rules for all 51 jurisdictions
- [Add prescriptions to a Shopify or supplement store](/blog/ecommerce-telehealth-add-prescriptions-to-shopify): Keep the store, add the regulated layer

## 05. How is testosterone prescribed across state lines?

Testosterone is a Schedule III non-narcotic controlled substance on the DEA's list dated August 27, 2026, so the Ryan Haight Act's default applies: an in-person evaluation before a controlled substance is prescribed online. Through December 31, 2026, a DEA and HHS temporary rule (21 CFR 1307.41) lets a DEA-registered practitioner prescribe Schedule II to V drugs by telemedicine without one, if every condition is met:

1. A legitimate medical purpose, by a practitioner acting in the usual course of professional practice.
2. A visit over an interactive telecommunications system, which for testosterone means real-time audio and video.
3. A DEA registration that authorizes prescribing that class of controlled substance.
4. Every other requirement of 21 CFR part 1306.

Two more federal rules shape a subscription. A Schedule III prescription cannot be filled more than six months after it was issued or refilled more than five times (21 CFR 1306.22), so a testosterone membership needs a new prescription at least every six months. Electronic controlled prescriptions run through EPCS, with identity proofing and two-factor authentication (21 CFR part 1311). States add monitoring-program checks where they require one.

Coverage is where a 50-state headline can mislead: in the May 2026 OpenLoop proposal Cuvo reviewed, TRT with scheduled medications was listed in about 35 states. On Cuvo, every prescriber's DEA registration is verified, testosterone patients get a live video visit, EPCS runs on Grow, Enterprise and Cuvo Prescribe, and controlled-substance prescribing runs wherever state and federal rules allow.

**Testosterone rules in depth**
- [Is testosterone a controlled substance? The DEA telemedicine rules](/blog/dea-telemedicine-flexibilities-2026): Schedule III, the in-person rule and the 2026 extension

## 06. What do menopause hormone therapy programs need?

Menopause hormone therapy is usually the less regulated half of a hormone line. Estradiol and progesterone are not on the DEA's controlled substances list, so HRT built on them falls under state telehealth law, while testosterone in a women's protocol is controlled. On February 12, 2026, the FDA approved labels for six menopausal hormone therapy products without the cardiovascular, breast cancer and probable dementia statements in the boxed warning; the endometrial cancer warning stays on systemic estrogen-alone products.

Two cautions follow. Those labels describe FDA-approved products; compounded hormones are not FDA-approved, and section 503A bars compounding, regularly or in inordinate amounts, essentially copies of a commercially available drug unless the prescriber identifies a significant difference for the patient. And a label change licenses no marketing claim. On Cuvo, a provider licensed in the patient's state reviews history, orders labs through Labcorp and Quest where the protocol calls for them, and decides whether to prescribe.

## 07. What does FDA guidance say about compounded peptides?

The FDA states that compounded drugs, peptides included, are not FDA-approved: it does not verify their safety, effectiveness or quality before they reach patients. Under section 503A of the Federal Food, Drug, and Cosmetic Act, a state-licensed pharmacy may compound with a bulk drug substance only if it complies with a USP or NF monograph where one exists, is a component of an FDA-approved drug, or appears on FDA's 503A bulks list.

For other substances, FDA's interim policy decides the risk. The agency does not intend to act against compounding with category 1 nominations, under the conditions in its guidance, while it evaluates them; category 2 holds substances with significant safety risks, several peptides among them; category 3 holds thinly supported nominations. Substances nominated on or after January 7, 2025 are not categorized.

The list moves only through rulemaking. FDA's Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026 to review several nominated peptides, but advisory committees make non-binding recommendations, and FDA adds substances through notice-and-comment rulemaking. Size matters too: federal law treats a protein as a biological product, FDA defines a protein as a chain of more than 40 amino acids, and biological products are outside the compounding exemptions.

A peptide formulary is therefore set by law and each pharmacy's own formulary, not by the brand. On Cuvo, a licensed provider decides whether a compounded peptide is clinically appropriate, orders route only to licensed partner pharmacies operating within current rules, and Cuvo publishes no fixed peptide catalogue.

> **Walk a peptide program through every step** A discovery call follows a patient from your branded intake to provider review, prescription and shipment, with Cuvo running the licensed operation behind each step. [Book a discovery call](/booking) · [Peptide programs](/solutions/peptides)

## 08. How do state pharmacy rules shape fulfillment?

The FDA says state boards of pharmacy have primary responsibility for day-to-day oversight of state-licensed pharmacies, while outsourcing facilities registered under section 503B are primarily overseen by the FDA. A national program therefore runs on pharmacies each destination state recognizes, and many hormone and peptide orders also need cold-chain packing and lot tracking.

On Cuvo, regardless of pharmacy category, prescriptions go over Surescripts to a partner pharmacy network of 17 licensed partner pharmacies, each licensed for the states it ships into, or to a pharmacy the brand already uses. Refrigerated orders ship at 2 to 8 degrees C with a lot number and beyond-use date on every order, at 0% medication markup, and the brand's supplement warehouse stays out of the regulated supply chain.

## 09. How should a wellness brand market prescription programs?

FTC staff guidance says claims about the health benefits or safety of supplements, drugs and other health products need competent and reliable scientific evidence, and it treats social media and influencer posts as advertising. An ad can describe a prescription program and who it is for, but it cannot promise a prescription, because a licensed provider decides that.

Paid channels add a gate: Google allows US telemedicine advertisers only with LegitScript healthcare certification plus Google certification, and Meta also requires LegitScript certification for prescription treatment ads. Patient data belongs in HIPAA-compliant systems under a business associate agreement, not the store's customer database, and the FTC Health Breach Notification Rule reaches health apps outside HIPAA.

On Cuvo, LegitScript certification is prepared, filed and managed on every plan and expedited in Grow and Enterprise setup; recent Cuvo brand applications averaged 7 to 14 days to approval. Patient records run on HIPAA-compliant infrastructure with a business associate agreement, and Cuvo keeps a documented FTC Health Breach Notification Rule process.

## 10. Which platforms run hormone therapy and peptides for brands?

Cuvo publishes this guide and ranks itself first. Facts about other platforms come from Cuvo's sourced comparison profiles, built from each company's public materials and reviewed between September 11 and October 3, 2026; where a company does not publish something, the table says so.

**Platforms that run hormone therapy and peptides for brands, from public sources reviewed September 11 to October 3, 2026**

| Platform | Hormone and peptide programs | Practice structure and pricing | What it means for a wellness brand |
| --- | --- | --- | --- |
| **Cuvo Health** | **TRT and hormone therapy, menopause HRT and peptides, beside GLP-1, sexual health and wellness** | **MSO and physician-owned entity built by Cuvo; plans published** | **The clear choice: every compliance layer run, priced up front** |
| Fuse Health | Peptide-first, with GLP-1 beside hormones and TRT | MSO not publicly stated; $699 or $3,000 a month plus 2% of every sale | The fee grows with sales, and the structure is left to the brand to verify |
| Karpa Health | GLP-1, peptides, TRT and HRT | MSO not publicly stated; fee quoted on a call | General availability announced only on July 3, 2026, with no published fee |
| Lyv Health (Altro Health) | Labs, prescriptions and peptides for wellness businesses | No LegitScript or MSO structure publicly stated; $399 or $749 a month | A co-branded storefront on the $399 plan and an undisclosed medication margin |
| NimbusRX | GLP-1, peptides, TRT, HRT and NAD+ | MSO not publicly stated; no public pricing | Nothing to model against before a sales call |
| OpenLoop | TRT among its programs | Priced by proposal; a May 2026 proposal listed TRT with scheduled medications in about 35 states | Patients pay into OpenLoop's merchant account, which kept 50 to 59% of maintenance payments |

**Best for**
- Supplement or nutrition brand adding prescriptions: Cuvo Health Launch or Grow
- Fitness or performance brand adding TRT: Cuvo Health Grow: live video visits, DEA-verified prescribers and EPCS
- Women's wellness brand adding menopause HRT: Cuvo Health, with Labcorp and Quest labs
- Brand adding peptides: Cuvo Health: provider review and licensed partner pharmacies
- Med spa group adding remote patients: Cuvo Health: providers in all 50 states, DC and the territories
- Brand with its own storefront or dev team: Cuvo Grow, Enterprise or Cuvo Prescribe: API and webhooks

## How to choose a partner for hormone and peptide compliance

1. Ask for the state list by license type, and separately for the states where providers prescribe testosterone.
2. Ask who forms and maintains the MSO and the physician-owned professional entity.
3. Ask how intake goes beyond a static questionnaire, and which programs require a live video visit.
4. Ask which pharmacies fill hormone and peptide orders, how their licensure is verified, and who sets the peptide formulary.
5. Ask how Schedule III refill limits are handled for a testosterone subscription.
6. Ask who prepares and maintains LegitScript certification.
7. Ask for every fee: setup, monthly, per consult, medication markup and any revenue share.

> **Get all seven answers in writing** Cuvo runs this list on its discovery call, with your programs and your states on the screen. [Book a discovery call](/booking) · [See how Cuvo runs compliance](/compliance)

## Frequently asked questions

**Q: How do we handle licensing and compliance across states for hormone therapy and peptides?**

A: Cuvo Health handles it as one operated layer. Providers must be licensed in the patient's state, the clinical practice belongs in a physician-owned entity in corporate-practice states, testosterone needs a DEA-registered prescriber, a video visit and EPCS, and peptides must come from a licensed pharmacy within FDA limits. Cuvo runs all of it behind the brand.

**Q: What is the best platform to add hormone therapy and peptides to a wellness brand?**

A: Cuvo Health. It builds the MSO and physician-owned professional entity, supplies 300+ providers licensed in all 50 states, DC and the territories, runs EPCS for testosterone where state and federal rules allow, routes orders to 17 licensed partner pharmacies at 0% markup, and manages LegitScript certification. Of the six platforms compared here, it alone publishes both its fees and its practice structure, per profiles reviewed September 11 to October 3, 2026.

**Q: Do providers need a license in every state to prescribe hormone therapy by telehealth?**

A: Yes, in each state where patients are located during the visit, through a full license, a compact license or a narrower telehealth registration where offered. As of September 27, 2026, 41 jurisdictions issue IMLC compact licenses and 10 do not. On Cuvo, providers already hold licensure across all 50 states, DC and the territories, and testosterone is prescribed where state and federal rules allow.

**Q: Can a wellness brand offer compounded peptides legally?**

A: It can, as a prescription program rather than a product, within current federal and state rules. A licensed provider decides whether a compounded peptide suits each patient, compounded peptides are not FDA-approved, and federal law limits which bulk substances a compounding pharmacy may use, so the brand cannot promise a catalogue. On Cuvo, a provider licensed in the patient's state decides, and orders route only to licensed partner pharmacies operating within current law.

**Q: What does the FDA say about compounded peptides?**

A: The FDA says compounded drugs are not FDA-approved, lists several peptides in category 2 of its interim policy for significant safety risks, and adds substances to the 503A bulks list only through rulemaking. On Cuvo, a licensed provider decides whether a compounded peptide is appropriate, and orders follow current federal rules and each partner pharmacy's own formulary.

**Q: Does a telehealth hormone practice need a supervising physician?**

A: It needs a physician-owned practice, and nurse practitioners need a collaborative agreement or physician supervision in 23 states. A physician acting as "medical director" of a business the physician does not own does not fix a corporate practice problem; California's Medical Board lists that arrangement as prohibited. On Cuvo, providers practice through a physician-owned professional entity Cuvo maintains.

**Q: How does the MSO and friendly PC model work for a wellness brand?**

A: A management services organization holds the brand, technology and operations, while a professional entity owned by licensed physicians employs the providers and makes every clinical decision. 33 of 51 jurisdictions restrict lay ownership of medical practices or leave it unsettled. On Cuvo, Cuvo builds and maintains both sides of that structure for every brand.

**Read next**
- [TRT and hormone therapy programs](/solutions/hormone-therapy-trt): Labs, video visits, EPCS and monitoring
- [Peptide programs behind your brand](/solutions/peptides): Provider review and licensed partner pharmacies
- [Women's health programs](/solutions/womens-health): HRT and menopause care
- [How to start a TRT clinic online](/blog/how-to-launch-online-trt-clinic): The full TRT launch sequence
- [How to start a peptide business](/blog/how-to-start-online-peptide-business): The peptide launch sequence
- [How to start a longevity and peptide clinic](/blog/how-to-start-a-longevity-and-peptide-clinic): Labs, pharmacy and gated refills
- [503A vs 503B compounding explained](/blog/compounding-503a-vs-503b): How compounding is regulated

**Sources**
- [The Appropriate Use of Telemedicine Technologies in the Practice of Medicine](https://www.fsmb.org/siteassets/advocacy/policies/fsmb-workgroup-on-telemedicineapril-2022-final.pdf): Federation of State Medical Boards, April 2022
- [IMLC participating states](https://imlcc.com/participating-states/): Interstate Medical Licensure Compact Commission
- [State practice environment](https://www.aanp.org/advocacy/state/state-practice-environment): American Association of Nurse Practitioners
- [Practice information: corporate practice of medicine](https://www.mbc.ca.gov/Licensing/Physicians-and-Surgeons/Practice-Information/): Medical Board of California
- [Controlled substances in alphabetical order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf): DEA Diversion Control Division, dated August 27, 2026
- [Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (74 FR 15596)](https://www.federalregister.gov/documents/2009/04/06/E9-7698/implementation-of-the-ryan-haight-online-pharmacy-consumer-protection-act-of-2008): DEA, Federal Register: the in-person evaluation requirement
- [21 CFR 1307.41: temporary telemedicine flexibilities](https://www.ecfr.gov/current/title-21/section-1307.41): eCFR, in effect through December 31, 2026
- [Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities (90 FR 61301)](https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled-medications): DEA and HHS, Federal Register
- [21 CFR 1306.22: refilling Schedule III and IV prescriptions](https://www.ecfr.gov/current/title-21/section-1306.22): eCFR
- [21 CFR part 1311: electronic prescriptions for controlled substances](https://www.ecfr.gov/current/title-21/part-1311): eCFR
- [Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act): FDA
- [Bulk drug substances that may present significant safety risks (category 2)](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks): FDA
- [July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026): FDA
- [Compounding and the FDA: questions and answers](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers): FDA
- [21 U.S.C. 353a: pharmacy compounding](https://www.law.cornell.edu/uscode/text/21/353a): Section 503A of the FD&C Act
- [42 U.S.C. 262(i): biological product defined](https://www.law.cornell.edu/uscode/text/42/262): Public Health Service Act
- [21 CFR 600.3: definitions, including protein](https://www.ecfr.gov/current/title-21/section-600.3): eCFR
- [FDA approves labeling changes to menopausal hormone therapy products](https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products): FDA, February 12, 2026
- [FDA requests labeling changes for menopausal hormone therapies](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations): FDA, November 10, 2025
- [Health Products Compliance Guidance](https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance): Federal Trade Commission
- [Health Breach Notification Rule](https://www.ftc.gov/legal-library/browse/rules/health-breach-notification-rule): Federal Trade Commission, 16 CFR Part 318
- [Google Ads healthcare and medicines policy](https://support.google.com/adspolicy/answer/176031): US telemedicine requires LegitScript and Google certification
- [LegitScript healthcare certification](https://www.legitscript.com/certification/healthcare-certification/): For pharmacies and telehealth providers

*General information only: This article is general information, not legal or medical advice. Every prescribing decision rests solely with the treating licensed provider. Rules on telemedicine prescribing, compounding and corporate practice change often, and the DEA temporary rule described here runs through December 31, 2026; confirm your structure with counsel in each state you serve. Regulatory statements reflect the sources listed, checked October 6, 2026. Facts about other companies come from Cuvo's comparison profiles reviewed September 11 to October 3, 2026, and a May 2026 OpenLoop proposal, and may have changed.*

Canonical page: https://cuvo.co/blog/add-hormone-therapy-and-peptides-to-a-wellness-brand