Hormone Therapy Compliance for Med Spas 2026: TRT, HRT, DEA & FDA Requirements

Hormone therapy — testosterone replacement therapy (TRT), hormone replacement therapy (HRT) for menopausal women, and compounded bioidentical hormone therapy (cBHRT) — is the fastest-growing service category in U.S. med spas in 2026. It is also the most regulated. A med spa can run a non-compliant Botox program for years before anyone notices. A non-compliant TRT program triggers DEA scrutiny, state medical board complaints, and malpractice exposure on a much shorter timeline. Period.

This guide covers what 2026 actually requires: who can prescribe, what DEA registrations are needed, how 503A and 503B compounding pharmacies fit in, what the FDA expert panel's recent recommendations mean for the industry, and what SOPs your practice needs before you accept your first patient. If you're already running TRT or HRT, this is the audit you should have done six months ago.

The 2026 Regulatory Shift: What the FDA Expert Panel Actually Recommended

Two federal moves in late 2025 and early 2026 changed the regulatory horizon for hormone therapy at med spas. Owners running TRT programs need to understand both, because each one — if finalized — would change what your practice can legally do.

The FDA Expert Panel on Testosterone Replacement Therapy

In December 2025, the FDA convened an expert panel to review the current labeling, indications, and regulatory status of testosterone replacement therapy. The panel issued recommendations that, if adopted, would represent the most significant change to TRT regulation since testosterone was placed on Schedule III in 1990. Two recommendations stand out:

• Expand FDA-approved indications to include age-related low testosterone. Currently, testosterone is approved only for classical hypogonadism — meaning a confirmed disease of the testes or pituitary. Off-label prescribing for age-related decline is widespread and is the legal foundation of the current TRT clinic model. Formal FDA approval for age-related indications would convert most current off-label use into on-label use.
• Remove testosterone from Schedule III. The panel concluded that testosterone's controlled substance designation is not supported by current evidence of abuse potential when prescribed in therapeutic doses. Removing it from Schedule III would eliminate the DEA registration requirement, the recordkeeping burden, and the prescribing limits that currently constrain who can prescribe and how.

On April 20, 2026, the FDA published a notice in the Federal Register inviting holders of currently approved TRT drug applications to contact the agency by April 30, 2026, to discuss expanded indications for low libido associated with idiopathic hypogonadism. The Federal Register notice is the procedural starting point — the actual rulemaking will take months to years. For full detail see the FDA Federal Register notice and the NBC News coverage of the panel recommendations.

The cBHRT "Difficult to Compound List" Threat

Separately, the FDA is evaluating whether to add certain compounded bioidentical hormone therapy preparations — including specific testosterone and estradiol formulations — to its "Demonstrably Difficult to Compound List." A drug placed on this list cannot be compounded by 503A pharmacies (and in some cases not by 503B outsourcing facilities either). For med spas that rely on compounded pellets, creams, or troches sourced from 503A pharmacies, an addition to this list would eliminate the ability to offer those preparations the next day.

The National Academies of Sciences, Engineering, and Medicine (NASEM) consensus report on compounded bioidentical hormone therapy recommended that FDA restrict use of cBHRT to patients for whom an FDA-approved equivalent is unsuitable. This conclusion is what's driving the current FDA review. ACOG's clinical consensus on cBHRT takes a similarly cautious stance, recommending FDA-approved hormone therapy as first-line.

What This Means for Your Practice Right Now

Both pending changes affect long-term planning, but the short-term reality is unchanged: testosterone remains Schedule III, all existing DEA rules apply, and cBHRT is still available through 503A and 503B pharmacies. The risk is that med spa owners who don't track these proceedings get blindsided when finalized rules force them to restructure their program with no notice. Build a compliance program around the rules as they are today, but architect it so a change in scheduling or compounding availability doesn't shut your hormone therapy line down.

Who Can Legally Prescribe Testosterone and Other Hormones at a Med Spa

The prescriber question is where most non-compliant TRT programs collapse. A med spa cannot prescribe — only a licensed clinician can. The clinician must have prescriptive authority under state law, must hold a DEA registration for testosterone (a Schedule III controlled substance), and must operate within their scope of practice as defined by their state's medical or nursing practice act.

Physicians (MD/DO)

A physician with an active state medical license and an individual DEA registration can prescribe testosterone, estradiol, progesterone, and other hormones in any U.S. state. This is the simplest model and the one DEA inspectors find easiest to verify. Most med spa medical directors fall into this category. The physician's DEA registration must be active, must be tied to a registered practice location, and must specifically include Schedule III authorization.

Nurse Practitioners (NPs)

NP prescribing authority varies dramatically by state. The Federation of State Medical Boards and individual state boards of nursing classify states into three groups:

• Full practice authority states (Arizona, Colorado, Oregon, Washington, New Mexico, and others) — NPs can prescribe Schedule III controlled substances independently, no physician collaboration required. An NP-owned and NP-led TRT clinic is fully legal in these states.
• Reduced practice states — NPs can prescribe Schedule III, but must have a written collaborative agreement with a supervising physician who has DEA authority. The collaborative agreement must specifically authorize Schedule III prescribing.
• Restricted practice states (Florida, California, Texas with limits, Georgia, and others) — NPs can prescribe controlled substances only under significant constraints, which may include physician co-signature requirements, dispensing limits (often 30-day maximum for Schedule III), or restrictions on certain drug classes.

Every NP-led TRT program needs to verify two things: (1) the NP holds an individual DEA registration with Schedule III authorization, and (2) the prescribing model conforms to state law for that specific state. Some states also require completion of the federal 8-hour DEA training for controlled substance prescribing. For a comparable nationwide breakdown of injectable prescribing authority, see our guide on who can inject Botox in the United States — the underlying scope-of-practice framework applies to hormone prescribing as well.

Physician Assistants (PAs)

PAs can prescribe testosterone in most states, but always under a supervising physician's authority. The supervisory agreement must explicitly include Schedule III prescribing. In many states the PA uses the supervising physician's DEA registration with the PA's own prescriber designator, while in others the PA must hold an individual DEA registration. The supervising physician's DEA registration is what authorizes the practice — if the supervising physician is not actively involved or moves to a non-DEA-registered status, the PA's authority lapses immediately.

Estheticians, RNs, and Other Unlicensed-to-Prescribe Staff

Cannot prescribe. Period. An RN can administer testosterone under a physician's standing order in many states, but an RN cannot initiate the prescription, change the dose, or independently order labs. Estheticians have no role in TRT prescribing or administration at any point. A med spa that allows non-prescribing staff to make hormone therapy decisions is exposed to charges of unlicensed practice of medicine — which is a felony in most states and a guaranteed loss of medical director.

DEA Schedule III: Registration, Recordkeeping, and Storage Requirements

Testosterone has been Schedule III under the Controlled Substances Act since 1990. Every med spa that prescribes, stores, dispenses, or administers testosterone — including pellets, injections, creams, and troches — is subject to DEA rules. The DEA's Practitioner's Manual is the primary federal reference document.

Individual Prescriber DEA Registration

Every prescriber issuing testosterone prescriptions must hold an active individual DEA registration that includes Schedule III authorization. The registration is location-specific — meaning the address on the registration must be a location where the prescriber actually practices. A prescriber working at two med spa locations may need two registrations (or, in some cases, an additional principal-place-of-business designation), depending on the structure.

The federal 8-hour DEA training requirement applies to all DEA-registered prescribers and must be completed before initial registration or first renewal after June 27, 2023. NPs, PAs, MDs, and DOs all fall under this requirement.

Facility DEA Registration

This is where most med spas go wrong. If your practice stores testosterone vials in a refrigerator for in-office administration, your facility itself needs its own DEA registration tied to that physical address. The medical director's personal DEA registration does not cover the facility — it only authorizes that physician's prescribing activity, not the practice's storage and dispensing activity. A separate facility registration is required for each physical location where Schedule III substances are stored.

If you operate a TRT clinic with a refrigerator full of testosterone cypionate vials and no facility DEA registration, you are operating outside federal law. DEA inspectors find this in routine inspections, and the penalties are not minor: civil monetary penalties run from $1,000 to $25,000 per violation, and willful violations can be prosecuted criminally.

Recordkeeping Requirements

DEA-registered facilities and prescribers must maintain detailed records for all Schedule III activity:

• Biennial inventory — a physical count of all Schedule III substances on hand, conducted at least every two years, with a written record retained for at least two years after the inventory date
• Receipt records — invoices and packing slips for every shipment of testosterone received, retained for two years
• Dispensing records — a log of every patient administration, including patient identifier, date, dose, lot number, and prescriber, retained for two years
• Prescription records — copies of every Schedule III prescription written, retained for two years (note: many states require longer retention — for example, five or seven years)
• Loss or theft reporting — any theft or significant loss must be reported to DEA on Form 106 within one business day of discovery, with a copy to local law enforcement

Storage and Security

Schedule III controlled substances must be stored in a "securely locked, substantially constructed cabinet" per DEA regulations. A locked refrigerator inside a locked treatment room with limited keyholder access satisfies this requirement in most inspections. A medication drawer in an open treatment area does not. The practice must also maintain a current list of authorized personnel with access to the controlled substance storage area.

Prescribing Limits

Schedule III prescriptions can be written for a maximum 90-day supply (federal limit) and can be refilled up to five times within six months of the original prescription date. After five refills or six months — whichever comes first — a new prescription is required. Some states impose tighter limits, such as 30-day supply or no refills, particularly in states with reduced or restricted NP prescribing authority. Always verify state-specific limits in addition to the federal floor.

The 503A vs 503B Compounding Question for cBHRT

Compounded bioidentical hormone therapy is widely used at med spas — pellets, topical creams, vaginal preparations, troches, and customized injectable combinations are common products. Every compounded medication a med spa uses comes from one of two pharmacy categories under the Federal Food, Drug, and Cosmetic Act, and the distinction matters for compliance.

503A Compounding Pharmacies

A 503A pharmacy compounds medications based on a patient-specific prescription. The patient must be identified before the medication is compounded. 503A pharmacies are regulated primarily by state boards of pharmacy, are exempt from FDA new drug approval requirements, and are not required to comply with FDA Current Good Manufacturing Practice (cGMP) standards. They are the source of most customized testosterone and BHRT preparations — pellets, creams, and combination injectables.

For a med spa using a 503A pharmacy:

• Each patient must have an individual prescription written for them specifically
• The practice cannot maintain "office stock" of 503A-compounded medications for use across multiple patients
• The compounded medication is not FDA-approved, and patients must be informed of this — preferably in writing as part of informed consent
• The med spa must verify the pharmacy is properly registered with the state board of pharmacy and not on any FDA enforcement list

503B Outsourcing Facilities

A 503B outsourcing facility is registered with the FDA, complies with cGMP standards, and is permitted to compound sterile drugs without patient-specific prescriptions. 503B-compounded medications can be maintained as office stock for in-office administration. The medications are still not FDA-approved, but the production environment is significantly more regulated than 503A.

For a med spa using a 503B facility:

• Office stock is permissible — the practice can hold a supply for in-office administration
• The facility must be on the FDA's published 503B registered facilities list (verify before purchasing)
• Patient consent should still disclose that the compounded medication is not FDA-approved
• 503B medications are typically more expensive than 503A but provide higher quality assurance and broader legal coverage

Hybrid Models and the Common Mistake

Many TRT clinics use a hybrid: 503B-compounded testosterone for office stock injection visits, 503A-compounded customized pellet preparations on a per-patient basis. This is fully legal as long as each leg of the model conforms to its own rules. The most common compliance failure is using 503A-compounded medication as office stock — buying a bottle of compounded testosterone meant for one patient and using it across multiple patients. This is a 503A violation, a state board of pharmacy issue, and a potential FDA enforcement matter all at once.

The 2026 cBHRT Risk

The FDA's evaluation of adding cBHRT to the Difficult to Compound List directly affects 503A pharmacy supply. Operators relying heavily on compounded pellets and customized BHRT preparations should identify FDA-approved alternatives (Aveed, Testopel, AndroGel, estradiol patches, oral progesterone) that could substitute on short notice if the rule changes. This is not paranoia — it's risk management for a service line you've already built.

Medical Director Liability in TRT and HRT Programs

Hormone therapy is one of the highest-liability service lines a medical director can sign on for. Three reasons: it's a controlled substance, it requires ongoing monitoring, and it's frequently delivered through delegated models where the physician sees few or no patients directly. State medical boards and the DEA both scrutinize physician oversight of TRT programs specifically.

The "Signature Without Substance" Problem

A medical director who signs TRT protocols, signs the practice's DEA facility registration, signs the standing orders — and then has no involvement in patient care, no chart reviews, no oversight of concerning lab values — is in the worst possible position. Their license is on the line for every prescription written in their name or under their authority. Yet they have no real visibility into what's being prescribed, to whom, or with what monitoring.

State medical boards have disciplined physicians for inadequate supervision of TRT programs. Common findings include: protocols signed but never reviewed against actual patient charts, standing orders that authorized treatments outside the patient's documented diagnosis, lab values left unaddressed (especially hematocrit greater than 54%, which is a hard stop for continuing testosterone therapy), and prescriptions written without documentation of a Good Faith Exam.

What Active Medical Director Oversight Looks Like

For a TRT program, active oversight means at minimum:

• A documented Good Faith Exam for every new TRT patient — performed by the medical director or by a delegated provider operating under signed standing orders. The exam must be in the chart before any prescription is issued.
• Initial prescription approval — the medical director reviews the diagnostic workup and approves the initial TRT prescription, even if a delegated NP or PA writes subsequent refills.
• Quarterly chart audits — at least 10% of active TRT patient charts reviewed quarterly, with documented findings and any corrective actions. Specific things to check: hematocrit trend, PSA trend, testosterone level on therapy, presence of consent documentation, lab cadence compliance.
• Adverse event review — every cardiovascular event, abnormal lab triggering a dose adjustment, or significant complication is escalated to the medical director within a defined timeframe and documented in the chart.
• Annual protocol review and re-signature — every TRT SOP is reviewed and re-signed annually, with the review date documented.

For deeper coverage of medical director duties and liability exposure across med spa service lines, read our guide on medical director liability and the companion piece on medical director requirements by state. The same supervision principles apply to hormone therapy, with an additional layer of DEA oversight on top.

Required Lab Panels and Ongoing Patient Monitoring

The Endocrine Society and American Urological Association both publish testosterone therapy guidelines, and both require specific lab work before initiation and during ongoing therapy. These guidelines are the de facto standard of care — a TRT program that does not follow them is exposed in malpractice litigation regardless of state-specific regulations.

Pre-Initiation Lab Panel

Before prescribing testosterone, the patient must have documented hypogonadism. The diagnostic standard requires:

• Two morning total testosterone readings — drawn between 7:00 and 10:00 a.m. on two separate days, both below the lab's reference range for hypogonadism (typically under 300 ng/dL, but reference ranges vary)
• Free testosterone — calculated or directly measured, particularly useful when SHBG is abnormal
• Sex hormone binding globulin (SHBG) — to interpret total versus free testosterone
• LH and FSH — to distinguish primary (testicular) from secondary (pituitary) hypogonadism
• Estradiol — baseline for monitoring conversion during therapy
• Hematocrit and hemoglobin — baseline for monitoring erythrocytosis risk
• PSA — for men age 40 and above, or any man with prostate disease risk factors; testosterone is contraindicated in active prostate cancer
• Comprehensive metabolic panel — kidney function, liver function, glucose
• Lipid panel — baseline for cardiovascular risk monitoring
• Prolactin — if secondary hypogonadism is suspected

A patient with a single low testosterone reading does not have a TRT-qualifying diagnosis. Two morning readings drawn at least one week apart are the standard. Insurance companies enforce this; plaintiff attorneys enforce this; medical boards enforce this. A med spa prescribing testosterone off a single afternoon draw of a 38-year-old man with no other workup is operating below the standard of care.

Ongoing Monitoring

Once therapy starts, patients must be monitored every 3–6 months for the first year and at least annually thereafter. The recurring panel must include:

• Total testosterone — to verify therapy is achieving therapeutic levels (mid-normal range, typically 400–700 ng/dL) without overshooting
• Hematocrit — the most important monitoring lab. Hematocrit above 54% is a hard stop for continuing testosterone at the current dose, with documented dose reduction or discontinuation required.
• Estradiol — to manage aromatization, especially in patients with gynecomastia symptoms or significant body fat
• PSA — annual at minimum for men 40+, more frequent if values are rising
• Lipid panel — annual
• Symptom review — energy, libido, mood, sleep, body composition

What Insurance and Cash-Pay Don't Change

The standard of care for TRT lab monitoring is the same whether the patient pays cash or is billing insurance. A med spa that runs a "subscription TRT" model with no lab monitoring or with monitoring intervals stretched out to save the patient money has built a malpractice liability into the business model. Every cardiovascular event in a poorly monitored TRT patient becomes a lawsuit where the absence of monitoring is exhibit one.

Informed Consent for Off-Label and Age-Related Hormone Therapy

Until and unless the FDA expands TRT indications to include age-related low testosterone, the majority of TRT prescribing in the U.S. — including most of what happens at TRT-focused med spas — is off-label. Off-label prescribing is legal. Failing to inform the patient that the treatment is off-label is not.

What Off-Label Consent Must Disclose

The informed consent for TRT or HRT must specifically disclose:

• Whether the prescribed indication is FDA-approved or off-label
• The known risks of testosterone therapy: erythrocytosis, cardiovascular events, sleep apnea exacerbation, prostate effects, infertility/reduced spermatogenesis, gynecomastia, mood changes, edema
• The known risks of compounded bioidentical hormones, including the fact that they are not FDA-approved and have not undergone the same safety and efficacy review as FDA-approved hormone products
• Alternatives — including FDA-approved hormone products, lifestyle modification (sleep, weight management, exercise), and the option of no treatment
• The need for ongoing lab monitoring and the patient's responsibility to attend monitoring appointments
• The expected duration of therapy and the conditions under which therapy will be discontinued

For BHRT specifically, consent must specifically address the NASEM and ACOG positions on compounded hormones — that FDA-approved alternatives are preferred where clinically appropriate, and that the patient understands they are receiving a non-FDA-approved compounded product. A med spa that hands a patient a generic consent form and never discusses these issues is exposed. The signed consent must reflect a conversation that actually happened.

Reconsent for Material Changes

If the patient's therapy changes materially — switching from FDA-approved testosterone cypionate to a 503A-compounded pellet, adding HCG, adding anastrozole — re-consent is required. The original consent does not extend to new medications or formulations.

State Scope-of-Practice Variance for NPs and PAs

Federal law sets the floor. State law decides what your med spa can actually do. Three categories shape NP/PA prescribing of TRT:

Full Practice Authority States

In Arizona, Colorado, Oregon, Washington, New Mexico, Maine, Iowa, Idaho, Vermont, New Hampshire, Hawaii, Alaska, Wyoming, Montana, Rhode Island, Connecticut, Nevada, North Dakota, Nebraska, South Dakota, Maryland, Minnesota, Massachusetts, Utah, Kansas, and the District of Columbia, NPs have independent prescriptive authority for Schedule III substances. An NP-owned and NP-led TRT clinic is fully legal with the NP's own DEA registration.

Reduced Practice States

Including New York, Illinois, Ohio, Pennsylvania, Wisconsin, Indiana, Kentucky, Arkansas, Louisiana, Mississippi, Alabama, West Virginia, New Jersey, Delaware. NPs require a written collaborative agreement with a physician for Schedule III prescribing. The agreement must specifically authorize controlled substance prescribing — a generic collaborative practice agreement is not sufficient.

Restricted Practice States

Florida, California, Georgia, Texas, North Carolina, South Carolina, Tennessee, Missouri, Oklahoma, Virginia, Michigan. NPs operate under stricter supervisory requirements that may include physician co-signature on Schedule III prescriptions, dispensing limits (commonly 30 days maximum), and limits on the number of NPs a single physician can supervise. Each state's specifics differ — Texas requires a delegated prescriptive authority agreement, California requires a furnishing number plus a supervising physician, Florida limits Schedule III refills.

For Texas-specific TRT requirements including DSHS, TMB, and APRN prescribing details, see our Texas hormone therapy compliance guide. For the broader regulatory map across all 50 states, see our med spa regulations by state pillar.

The Practical Implication

An NP who runs a successful TRT clinic in Phoenix, Arizona, cannot simply replicate the model in Houston, Texas, by hiring a local NP. The compliance structure required in Texas (supervising physician with delegated prescriptive authority, formulary limits, monthly chart review by the physician) is fundamentally different from the autonomous Arizona model. Multi-state hormone therapy expansion requires state-by-state legal review every time.

Compliant Marketing and FTC Rules for Hormone Clinics

Hormone therapy advertising is a flashpoint for FTC enforcement and state medical board complaints. Three problems show up repeatedly in TRT and BHRT marketing:

Unsupported Performance Claims

Claims like "Boost your testosterone by 200%," "Reverse aging," "Lose 50 pounds with hormone optimization," or "Cure your depression" are FTC violations and state board violations. The FTC requires that health claims be substantiated by competent and reliable scientific evidence. Most generic TRT and BHRT marketing claims do not meet this standard. Specific quantified claims about outcomes need underlying clinical evidence that supports the specific claim.

Implied FDA Approval

Marketing compounded bioidentical hormones with phrasing like "FDA-regulated pharmacy" or "compounded under FDA standards" is misleading if it implies the medication itself is FDA-approved. Compounded medications are not FDA-approved. The pharmacy that produces them is regulated, but the medication is not the same as an FDA-approved drug. Advertising must be clear about this distinction.

Before/After Photos and Testimonials

Patient testimonials describing therapy results must reflect the typical patient experience — not a single best-case outcome. The FTC requires either that testimonials reflect typical results, or that the advertisement clearly discloses what results consumers can generally expect. Stock-photo testimonials and undisclosed compensated reviews are violations. For comprehensive coverage of before/after photo compliance, see our guide on FTC before/after photo rules for med spas.

State-Specific Telehealth Advertising

Many TRT clinics operate telehealth models advertising "TRT online — get started today." If the practice is advertising in states where the prescribers do not hold licenses, that's unauthorized practice of medicine. Telehealth TRT requires prescriber licensure in every state where patients are seen, even if the practice is physically located in only one state.

The cBHRT "Difficult to Compound List" Threat — And What Owners Should Do Now

If the FDA finalizes additions to the Difficult to Compound List that include common cBHRT preparations, 503A pharmacies will stop producing them. For practices built around customized pellets, creams, or troches, this is an existential service line risk. The good news is that the regulatory process is slow — the bad news is that owners who don't track it will be caught flat-footed if and when it lands.

Practical Steps Now

• Map your supply — for every cBHRT product your practice currently uses, identify which 503A or 503B pharmacy supplies it and what the substitute product would be if the supplier could no longer compound it. The Florida Healthcare Law Firm's analysis of the Difficult to Compound List risk covers the specifics of which preparations are at highest risk.
• Identify FDA-approved alternatives — for testosterone: Testopel (pellets), AndroGel, Aveed, Depo-Testosterone, Xyosted. For estradiol: patches, oral preparations, vaginal rings. For progesterone: Prometrium oral, IUD-based delivery. Pre-validate which approved products could substitute for current cBHRT preparations.
• Update consent forms — current cBHRT consent should already disclose non-FDA-approval; add a clause noting that the FDA may at any time restrict or eliminate availability of compounded preparations and that the practice may need to transition the patient to alternative therapy with no notice.
• Avoid building marketing around a single compounded formulation — if your brand promise is "personalized BHRT pellets" and the FDA eliminates compounded pellets, your brand is suddenly stuck. Build messaging around hormone therapy outcomes, not around a specific compounded product.

Building a Compliant TRT/HRT Program: The SOP Stack You Actually Need

A compliant hormone therapy program is a documentation system. State boards, DEA inspectors, malpractice insurers, and plaintiff attorneys all want to see written protocols. Verbal protocols and "everyone knows what to do" are not protocols. Here is the minimum SOP stack every TRT/HRT program needs:

1. TRT Initiation SOP

Defines patient eligibility (age, symptoms, contraindications), required labs and how they're interpreted, Good Faith Exam requirements, informed consent process, initial dosing guidelines, and follow-up scheduling. This is the most important SOP in the entire program because it gates every subsequent prescription.

2. Delivery Method SOPs

Each delivery method needs its own protocol: injectable testosterone (IM and subcutaneous technique, site rotation, needle disposal), testosterone pellet insertion (sterile technique, anesthesia protocol, post-procedure care, complication management), topical creams (application technique, transference precautions), troches (administration instructions). Pellet insertion in particular is a surgical procedure — it needs the same protocol depth as any minor surgical procedure in your practice.

3. Lab Monitoring SOP

Defines the cadence of follow-up labs, the specific tests required at each interval, threshold values that trigger dose adjustment or discontinuation, and the documentation requirements for each lab review. Should specify the hematocrit hard-stop value (54%), the PSA review protocol, and the estradiol management approach.

4. Controlled Substance Management SOP

Covers DEA inventory procedures (biennial physical count, daily dispensing log), storage requirements (locked cabinet, key control), loss/theft reporting (DEA Form 106 within one business day), prescription pad security, and the medical director's review of monthly controlled substance activity.

5. Compounded Medication Management SOP

Identifies the practice's approved compounding pharmacies (503A and 503B), the verification process for each (state board registration, FDA enforcement list check, BAA where applicable), the documentation requirements for patient-specific prescriptions to 503A pharmacies, and the informed consent process for compounded products.

6. Adverse Event Response SOP

Covers the recognition and response to TRT-specific adverse events: severe erythrocytosis, cardiovascular events during therapy, mood changes, sleep apnea exacerbation, prostate issues, injection site reactions, anaphylaxis to compounded preparations. Each event type needs a defined response protocol with escalation criteria to the medical director and to emergency services.

7. Medical Director Chart Review SOP

Documents the cadence of medical director chart audits (quarterly minimum), the percentage of active patient charts reviewed, the specific items checked in each review, the documentation format for findings, and the process for corrective action when issues are identified. This SOP is your medical director's protection during a board complaint — it demonstrates that supervision was active and ongoing, not nominal.

8. Off-Label Use and Informed Consent SOP

Defines the consent process for off-label TRT prescribing, the consent process for compounded BHRT, the specific risks that must be disclosed, the re-consent triggers for material changes in therapy, and the documentation standards for consent in the chart.

Most full TRT/HRT programs need 8–12 SOPs total when state-specific requirements and additional service lines (HCG protocols, anastrozole co-administration, peptide therapies) are included. For broader operational SOP requirements — HIPAA, staff training, intake — see our complete guide to med spa policy and procedure manuals and the Operations & Compliance Kit.

The TRT/HRT-specific SOPs are the ones most med spas don't have. The GLP-1 boom of 2024–2025 trained the industry to take controlled treatment protocols seriously — read our GLP-1 compliance guide for the same pattern applied to weight loss medication. Hormone therapy compliance is the next step up: an additional layer of DEA oversight, a higher monitoring burden, and a significantly higher liability profile when things go wrong.