BHRT & Hormone Pellet Consent Form Template (2026)

A drafting guide, not advice. This page explains how a hormone therapy consent document is usually organized and what each part is for. It gives no doses, pellet quantities, lab values or timing, takes no position on who should be treated, and does not describe any state's law. Before a patient signs anything built from it, the prescriber, your medical director and a healthcare attorney in your state have to approve the text.

Hormone therapy sits in an unusual spot on a med spa menu. Most aesthetic services are a visit: the patient arrives, is treated, and goes home with aftercare instructions. Testosterone replacement and menopausal hormone therapy are a course of prescription treatment, often delivered through more than one route over time, with blood work that steers what happens next. Some patients will receive a compounded preparation described as "bioidentical." Some will have pellets placed under the skin. Some will be prescribed a drug that federal law treats as a controlled substance. A single generic consent cannot capture all of that, and the gaps tend to surface at the worst moment: in a chart review, a board complaint or a claim.

This page covers one document only: the patient consent for hormone therapy offered in a med spa or wellness setting, whether by pellet, injection or cream, and whether the hormone is testosterone or estradiol. Everything around that document, including DEA registration, pharmacy sourcing, prescriber qualifications and lab standards, is covered in our hormone therapy compliance guide for med spas. Where a statement on this page depends on a fact from that guide, we link to it rather than restate it in new words.

What Does a BHRT or Hormone Pellet Consent Form Have to Contain?

The short verdict: enough specific information that someone reading the chart later could tell exactly what the patient agreed to receive, from whom, how, and with what known downsides, and that the patient understood the plan depends on follow-up. Generic statements such as "hormone optimization may carry risks" do not meet that bar.

Our hormone therapy compliance guide sets out what off-label hormone consent must disclose. Turned into a working document, those disclosures become the following blocks:

• The treatment plan in identifiable terms: which hormone or hormones, which delivery method, and which product or pharmacy.
• Approval status: whether the indication is FDA-approved or off-label, and whether the product is FDA-approved or compounded.
• A plain explanation of "bioidentical": what the word describes and what it does not promise.
• Alternatives, including FDA-approved hormone products, lifestyle measures and no treatment.
• Risks, organized by hormone and by delivery method, with the pellet procedure's own risks kept separate.
• Screening the prescriber completed, including the patient's fertility goals and pregnancy status, and the patient's duty to report changes.
• A lab monitoring commitment that follows the prescriber's protocol and explains what happens if labs are missed.
• A controlled-substance acknowledgment on any form that covers testosterone.
• A pellet insertion acknowledgment as a separate signed page whenever pellets are part of the plan.
• Warning signs and how to reach the practice, including outside office hours.
• Financial terms written for a course of therapy, not a single visit.
• Signatures and identification of the patient and the prescriber, plus the form's version.

The rest of this guide takes those blocks one at a time, then shows how they sit together on paper.

Who Is Responsible for Obtaining Hormone Therapy Consent?

The prescriber. Consent to a prescription therapy is consent to a clinical decision, and the person who made that decision is the one who can explain why it was made, what else was considered and what the patient should watch for. Front-desk staff can hand the patient the paperwork, and a nurse can reinforce injection or application teaching, but neither can stand in for the prescriber's conversation. Our hormone therapy guide is blunt that staff without prescriptive authority cannot initiate a hormone prescription, change the dose or independently order labs; the consent conversation belongs with the clinician who can.

Sequence matters too. The prescriber completes the evaluation first, including the history, the examination and the lab review described in our good faith exam form template, then discusses the plan, then the patient signs, and only then is anything dispensed, injected, applied or implanted. A form signed in the waiting room before the patient has met the prescriber records the wrong order of events.

Prescribing authority depends on the state

Whether a physician, nurse practitioner or physician assistant may prescribe hormones in your clinic, under what supervision or collaboration, and who may place pellets, all turn on state law and on each clinician's license and registrations. This page does not attempt that analysis. Our hormone therapy compliance guide walks through the prescriber question; your consent form should simply print the name and credential of the clinician who actually holds that authority for this patient, so the document and the chart agree.

How Should the Form Describe Each Delivery Method?

Patients often arrive having heard about one route from a friend or an advertisement. The form should describe the route the prescriber has actually chosen, so that the patient's expectations match the plan. Where a patient may move between routes, the form lists only the current one and the practice re-consents when it changes.

Injections

For injectable hormone therapy, the description block should say whether the injections will be given in the clinic, self-administered at home, or a mix of both. If the patient is self-injecting, the form records that injection teaching was given, by whom, and that the patient received written instructions on technique, site rotation and needle disposal, which our compliance guide lists among the elements of an injectable delivery protocol. The schedule itself belongs in the prescription and the written plan, not on the consent form, because it changes as labs come back.

Creams and other topical preparations

Topical hormone therapy brings a risk that injections and pellets do not: the medication can pass to other people through skin contact. Our compliance guide lists transference precautions as part of the topical delivery protocol. The consent form should therefore include an acknowledgment that the patient received the prescriber's written application and transference instructions and understands why they matter for partners, children and anyone else in close contact. The form does not need to restate those instructions; it needs to show they were given.

Pellets, which are a minor procedure

Pellet therapy differs from the other routes in kind, not degree. Placing pellets involves breaking the skin under sterile conditions, and our compliance guide treats pellet insertion as a surgical procedure that needs the same protocol depth as any minor procedure in the practice. Our Texas hormone therapy page likewise describes the implantation as a minor surgical procedure requiring a trained provider, a sterile field and written protocols covering complications such as extrusion and infection.

Because of that, the medication consent and the procedure consent should be two documents, or at least two clearly separate signed sections. The medication consent covers the hormone, its approval status, its risks and the monitoring plan. The procedure acknowledgment covers the insertion itself. Keeping them apart has a practical benefit: each pellet visit gets its own procedural acknowledgment, while the medication consent is renewed only when the therapy changes.

A pellet insertion acknowledgment usually records:

• The date, the clinician performing the insertion and their credential, and the insertion site chosen.
• That local anesthesia will be used as set out in the practice's written insertion protocol, and that the patient has disclosed any reaction to local anesthetics.
• The procedural risks our pages list for pellets: bruising, infection at the site and extrusion of a pellet.
• That once pellets are implanted, the dose cannot be taken back out the way an injection schedule can be paused, a point our consent forms guide includes in its pellet elements.
• That the patient received written aftercare instructions and knows which wound changes to report.
• The patient's signature and the date, and the inserting clinician's signature.

The product lot and the pellet details belong in the procedure note and the controlled-substance record, not on the patient's acknowledgment.

How Should the Form Handle "Bioidentical" and Compounded Products?

This is the block most hormone consents get wrong, usually because marketing language leaks into a clinical document.

What "bioidentical" does and does not tell the patient

"Bioidentical" describes the structure of a hormone molecule. It is not a regulatory category and it is not a statement about safety, and the consent form should say nothing that implies otherwise. A clean approach is a short factual sentence: the hormone prescribed is described as bioidentical; that description refers to its chemical structure; it does not mean the product is FDA-approved, and it does not mean the product carries fewer risks. Our compliance guide flags phrases such as "FDA-regulated pharmacy" or "compounded under FDA standards" as misleading in advertising when they suggest the medication itself is approved. The same phrases are no better in a consent form.

The compounded-product disclosure

Our hormone therapy guide is direct on this: compounded medications are not FDA-approved, and patients must be told so, preferably in writing as part of informed consent. That applies whether the preparation comes from a 503A pharmacy on a patient-specific prescription or from a 503B outsourcing facility. The guide notes that consent should still disclose non-approval for 503B products, even though the production environment is more heavily regulated. Our 503A versus 503B sourcing guide explains the difference between the two pharmacy types, and it describes a compounding-specific consent that acknowledges the product is not FDA-approved and explains its known risks.

For a hormone form, the compounded-product block usually records:

• The product's name as it appears on the prescription and pharmacy label, and the dispensing pharmacy.
• A statement that the preparation is compounded and is not FDA-approved, and that it has not gone through the same safety and efficacy review as FDA-approved hormone products.
• That the prescriber discussed FDA-approved alternatives and, per our compliance guide, that such alternatives are preferred where clinically appropriate, with the reason a compounded product was chosen for this patient recorded in the chart.
• The clause our compliance guide recommends adding: that the FDA may restrict or eliminate availability of compounded preparations, and that the practice may need to move the patient to another therapy at short notice.

A form that covers both FDA-approved and compounded products should make the patient's actual product obvious. A pair of tick boxes with neither ticked, or both, is a common audit finding. Do not assume the status of any particular pellet or cream; take it from the prescription and the pharmacy label for that patient.

On-label or off-label

Separately from the product question, the form should state whether the prescribed use is within the product's approved indication or off-label. Our compliance guide explains that much testosterone prescribing for age-related decline is off-label, that off-label prescribing is legal, and that failing to tell the patient is not. A sentence with a field the prescriber completes is enough: the indication for this treatment is, and this use is on-label or off-label.

Which Risks Should a Hormone Therapy Consent List?

List risks by hormone, then by route, then for the pellet procedure on its own page. A single merged paragraph forces the patient to work out which warnings apply to them, and it makes the form harder to defend because it is unclear what was emphasized. Leave a line for the patient's initials next to each serious risk.

Testosterone

Our compliance guide lists the known risks of testosterone therapy that consent must disclose:

• Erythrocytosis (a rise in red blood cell concentration)
• Cardiovascular events
• Worsening of sleep apnea
• Prostate effects
• Infertility and reduced sperm production
• Gynecomastia
• Mood changes
• Edema (fluid retention)

The same guide notes that testosterone is contraindicated in active prostate cancer, and our Texas page lists prostate cancer history, polycythemia and severe sleep apnea among the contraindications the prescriber should assess. Those belong in the screening block, covered below, rather than the risk list.

Estradiol and other menopausal hormone therapy

Our consent forms guide frames the risk section for hormone therapy by hormone class, including cardiovascular, thromboembolic (blood clot) and malignancy considerations, and lists hormone-sensitive malignancy, undiagnosed abnormal bleeding and active thromboembolic disease as contraindications to screen for. Populate the estradiol section from the current labeling of the product prescribed, or for a compounded preparation from the prescriber's written protocol, and have your medical director confirm the list.

Route-specific risks

• Injections: injection-site reactions, which our compliance guide names in its adverse event protocol.
• Topicals: transfer to other people through skin contact, as above.
• Compounded preparations: the possibility of allergic reaction, including the anaphylaxis to compounded preparations our compliance guide includes in its adverse event protocol.
• Pellets: on the separate procedural page, as described earlier.

We do not quantify any of these risks here, and the form should avoid numbers unless your medical director supplies them from labeling or the literature and is prepared to keep them current. A qualitative list the patient can follow, discussed out loud, is better than a percentage nobody can source.

What Screening Should the Form Document, Including Fertility and Pregnancy?

The screening block is not a self-diagnosis questionnaire. It records that the prescriber asked specific questions and that the patient answered truthfully, and it puts the patient on notice to report changes.

Medical history items

The contraindications listed above become yes-or-no questions the prescriber reviews: prostate cancer history and prostate symptoms for testosterone patients; hormone-sensitive cancers, unexplained bleeding and clotting history for estradiol patients; sleep apnea; blood disorders; and current medications. The form should end this block with a line for the prescriber's initials confirming the answers were reviewed before prescribing, not just collected.

Fertility

Because our compliance guide lists infertility and reduced sperm production as risks of testosterone therapy, fertility deserves its own question rather than a line in the risk list. Ask whether the patient is trying to conceive or may want to in future, record that the prescriber discussed the fertility effects of the planned therapy, and record any referral or alternative discussed. Our consent forms guide also lists fertility effects, and contraception counseling where relevant, among the elements of a hormone therapy consent.

Pregnancy and breastfeeding

Record the patient's current pregnancy and breastfeeding status where relevant to the patient, and the prescriber's instructions about contraception. Add an undertaking that the patient will tell the practice promptly if they become pregnant or begin trying to conceive, and that treatment will be reviewed before any further dose. The clinical decision about what follows is the prescriber's and belongs in the protocol, not the form.

The duty to report changes

Close the screening block with a commitment to report any new diagnosis, new medication, hospital visit or significant symptom before the next scheduled treatment or refill.

How Should the Lab Monitoring Acknowledgment Be Worded?

Hormone therapy is steered by blood work, and the consent should make that a two-sided agreement: the practice will order and review labs, and the patient will complete them. Our compliance guide lists the need for ongoing lab monitoring, and the patient's responsibility to attend monitoring appointments, among the required disclosures.

Write the acknowledgment around the prescriber's protocol rather than fixed values. A workable version reads, in substance: the patient understands that lab tests are required before treatment begins and at intervals set by the prescriber's protocol; the patient will complete them; the prescriber will review the results and may adjust, pause or stop therapy based on them; and further prescriptions, refills or pellet visits may be withheld until overdue labs are completed. Attach or reference the written monitoring schedule the patient received, so the form never needs editing when the protocol changes.

Do not print test names with target ranges, or a timetable, on the consent itself. Those details live in your lab monitoring protocol, which your medical director signs and updates; putting them on a patient-signed form creates a second, quickly outdated copy.

When Does the Form Need a Controlled-Substance Acknowledgment?

Whenever testosterone is part of the plan. Testosterone is a Schedule III controlled substance under the Controlled Substances Act, as our Texas hormone therapy and DEA compliance guide and our national compliance guide both state, and that status applies to injections, creams and pellets alike. The practice's DEA registration, storage and recordkeeping obligations are covered on those pages and are not patient-facing; the consent form only needs the part the patient must understand and agree to.

A testosterone acknowledgment typically has the patient confirm that they understand:

• Testosterone is a controlled substance and is prescribed only for them.
• They will not share, sell or give it to anyone else, and will keep any home supply secure and out of reach of others.
• They will tell the prescriber about every other source of testosterone or related products, including prescriptions from other clinicians.
• Prescriptions and refills follow the prescriber's protocol and applicable law, and lost or stolen medication must be reported to the practice.
• The practice may decline to continue prescribing if these terms are not followed.

Keep this block off estradiol-only forms unless your medical director and counsel direct otherwise. A controlled-substance acknowledgment on a form for a product that is not controlled confuses the patient and weakens the block where it matters.

What Else Belongs on the Form: Alternatives, Warning Signs and Money?

Alternatives

Our compliance guide lists the alternatives a hormone consent should disclose: FDA-approved hormone products, lifestyle measures such as sleep, weight management and exercise, and the option of no treatment. Where the patient is receiving a compounded product, the alternatives block and the compounded-product block reinforce each other, which is the point.

Duration and stopping

The same guide lists the expected duration of therapy, and the conditions under which therapy will be discontinued, as required disclosures. The form can note that hormone therapy is often long-term, that the patient may stop at any time after discussing it with the prescriber, and that the prescriber may pause or stop treatment for safety reasons, missed labs or non-adherence to the controlled-substance terms. For pellets, add that stopping takes effect only once implanted pellets are exhausted.

Warning signs and contact

List the symptoms that should prompt a call to the practice and those that need emergency care, as set out in your adverse event protocol, and print a working after-hours contact route. A patient with chest pain, leg swelling or a hot, painful insertion site should not have to search a website to learn what to do.

Financial terms

Hormone programs are commonly sold as packages or memberships, which makes the money section more involved than for a one-off treatment. The form should say what the fee covers and what it does not, such as lab work billed separately or by an outside laboratory; how pellet visits are priced; whether prescriptions filled at an outside pharmacy are paid there; the cancellation and refund position, including what happens to prepaid amounts if the prescriber stops therapy for safety reasons; and that payment does not guarantee a prescription or any particular result. Our compliance guide's warning about "subscription TRT" with monitoring stretched out to save the patient money is a reminder that pricing should never be structured so that labs look optional.

What Does a Hormone Therapy Consent Template Look Like Laid Out?

The outline below orders the blocks so a patient can read straight through and a reviewer can find each element quickly. It is a skeleton for your drafting, not text to copy; the wording comes from your prescriber, your medical director and your counsel.

The signature block

The patient's statement should be specific: they have read the form or had it read to them, the prescriber named on the form explained the treatment, alternatives and risks, their questions were answered, and they agree to the plan as described. Below it sit the patient's signature and date, the prescriber's printed name, credential, signature and date, and, if a different clinician provided injection or application teaching, that clinician's name. Print the form's version identifier in the footer of every page so the chart shows which text the patient signed. If your practice uses electronic signatures, our consent forms guide covers how they fit inside an EMR.

Which Hormone Consent Mistakes Cause the Most Trouble?

One form for "hormones"

A single document that lists testosterone, estradiol and progesterone, every route and every risk, with nothing marked to show which applies, does not tell anyone what this patient agreed to. Use a core form with hormone-specific and route-specific sections that are completed or struck through.

"Natural" language in a clinical document

Phrases lifted from the website, such as "natural," "safer" or "the same as your body makes, so no side effects," turn a disclosure into a sales pitch. Strip them out.

The compounded status left unstated

If the chart shows a compounded pellet and the form never says the product is not FDA-approved, the most important disclosure in the document is missing.

The pellet procedure folded into the medication consent

When the insertion risks are buried in the hormone section, there is no record specific to each procedure visit. Give the insertion its own page and its own signature every time.

Testosterone with no controlled-substance terms

A form that never tells the patient testosterone is controlled gives the practice nothing to point to when medication is shared, a supply is lost or a patient is obtaining it elsewhere.

Fixed lab schedules printed on the form

Once the protocol changes, the signed form and the protocol disagree. Refer to the protocol instead.

A consent never renewed

Our compliance guide gives examples of material changes that require re-consent, such as switching from FDA-approved testosterone cypionate to a 503A-compounded pellet, or adding HCG or anastrozole. Patients who began on one product and have quietly moved to another are a frequent finding.

How Should You Keep and Renew Hormone Therapy Consents?

Keep the form tied to the chart

File each signed consent with the evaluation it followed, the prescription it supports and, for pellets, the procedure note for that visit. A consent that cannot be matched to a specific product, pharmacy and prescriber carries much less weight than one that sits inside a consistent record.

Retention

Treat signed consents as part of the medical record and keep them for at least as long as the rest of that record, under your state's retention rules and your malpractice carrier's guidance. Controlled-substance records for testosterone have their own requirements, covered in our compliance guide; the patient consent should not be the only place those obligations are tracked. For the general framework, see our med spa medical records retention guide. Keep superseded versions of the blank form too, so you can show what a patient signed years later.

When to re-consent

Re-consent whenever something material changes: a new hormone, a new route, a move between FDA-approved and compounded product or to a different pharmacy, an added medication, a change of prescriber, a relevant new diagnosis or pregnancy, a serious adverse event, or a new version of the form. Many practices also re-review the consent at a set point in the medical director's chart-review cycle, which our compliance guide describes. The pellet acknowledgment, as noted, is signed at every insertion visit regardless.

How Does Hormone Consent Compare With Your Other Prescription Consents?

Hormone therapy shares more with GLP-1 programs than with aesthetic procedures: both are ongoing prescription therapy, both may involve compounded products, and both depend on follow-up. Our semaglutide consent form template shows how that structure works for weight-loss medication, and our IV therapy consent form template covers infused medications. What sets hormone consent apart is the combination of a controlled substance, a possible implanted dose that cannot be withdrawn, and fertility effects that can matter for years. The rules that apply to every consent in your practice, such as capacity, minors and photo releases, are in our med spa consent forms guide, and the full set of documents a practice keeps is listed in our complete list of med spa forms.

Key Takeaways

• The prescriber who evaluated the patient obtains consent, after the evaluation and before any hormone is given.
• Name the hormone, route, product and pharmacy, and state FDA-approved or compounded, on-label or off-label.
• Explain that "bioidentical" describes structure, not approval or safety.
• List risks by hormone and route; give pellet insertion its own signed acknowledgment each visit.
• Document fertility goals and pregnancy status as screening items, with a duty to report changes.
• Tie monitoring to the prescriber's protocol, and make refills conditional on completed labs.
• Add controlled-substance terms whenever testosterone is prescribed.
• Keep consents with the record, keep old form versions, and re-consent on any material change.

Everything above describes the shape of a hormone therapy consent document and the habits that keep it current. Nothing here is a clinical standard, a recommendation of any hormone, product or dose, or a summary of any state's law. Treat it as a drafting aid: the prescriber and your medical director sign off on the content, a healthcare attorney in your state reviews it, and the risk wording is checked against current labeling or your written protocol before any patient sees it.