Keeps Safety, Regulation and Compliance: An Independent Review

Prescription access and medication affordability image for Keeps Safety, Regulation and Compliance: An Independent Review

At a glance

  • Platform type / direct-to-consumer telehealth subscription for men's hair loss
  • Core medications / oral finasteride 1 mg (FDA-approved 1997) and topical minoxidil 5% (OTC, FDA-approved 1988)
  • Prescribers / U.S.-licensed physicians in each patient's state
  • Pharmacy / medications dispensed through state-licensed pharmacies
  • Regulatory framework / operates under state telehealth laws; no single "FDA approval" of the platform itself
  • Finasteride efficacy / 83% of men maintained or increased hair count over 2 years in the key trial [1]
  • Minoxidil efficacy / 5% solution produced 45% more hair regrowth than 2% solution at 48 weeks [2]
  • Most common finasteride side effects / decreased libido (1.8%), erectile dysfunction (1.3%) in clinical trials [1]
  • Subscription model / monthly or quarterly auto-ship with physician oversight

What Keeps Actually Prescribes

Keeps offers two FDA-approved treatments for androgenetic alopecia: oral finasteride 1 mg daily and topical minoxidil 5%. Both drugs have extensive regulatory histories predating the platform by decades.

Finasteride received FDA approval in 1997 under the brand name Propecia for male pattern hair loss at the 1 mg dose. The drug is a type II 5-alpha reductase inhibitor that blocks conversion of testosterone to dihydrotestosterone (DHT), the androgen responsible for follicular miniaturization in genetically susceptible men. In the original phase III trial, 83% of men on finasteride 1 mg maintained or increased hair count at 2 years versus 28% on placebo [1]. Minoxidil, originally developed as an oral antihypertensive, gained FDA approval as a topical hair-growth agent in 1988. A 48-week randomized trial comparing 5% versus 2% topical minoxidil demonstrated that the higher concentration produced 45% more hair regrowth, with a similar side-effect profile [2].

Keeps does not manufacture these drugs. It functions as a prescribing and dispensing intermediary. That distinction matters for understanding its regulatory posture.

How Keeps Handles Prescriptions and Physician Oversight

Every Keeps prescription originates from a licensed physician. The platform uses an asynchronous telehealth model: patients complete an online questionnaire and upload photos of their scalp, then a physician licensed in the patient's state reviews the submission and decides whether to prescribe.

This model complies with telehealth prescribing rules that vary by state. The Federation of State Medical Boards (FSMB) requires that a valid physician-patient relationship exist before prescribing. Most states now permit this relationship to begin via telehealth, a regulatory shift accelerated during the COVID-19 pandemic when the DEA and state boards relaxed in-person requirements. Finasteride is not a controlled substance, so it faces fewer prescribing barriers than medications requiring DEA-scheduled oversight.

One legitimate criticism of asynchronous telehealth platforms: the photo-and-questionnaire model may not catch every contraindication that an in-person dermatologic exam would reveal. A 2021 cross-sectional study of direct-to-consumer telehealth dermatology platforms found that diagnostic concordance with in-person visits was approximately 83% for common conditions, though hair loss was not isolated as a category [3]. For a condition like androgenetic alopecia, where diagnosis is largely clinical and pattern-based, the risk of misdiagnosis is lower than for, say, a pigmented lesion requiring dermoscopy.

Finasteride Safety: What the Data Actually Shows

The finasteride safety discussion centers on sexual side effects and the controversial concept of post-finasteride syndrome (PFS). Here is what the evidence base supports.

In the original Propecia clinical trial program, finasteride 1 mg produced the following adverse events versus placebo: decreased libido (1.8% vs. 1.3%), erectile dysfunction (1.3% vs. 0.7%), and decreased ejaculate volume (0.8% vs. 0.4%) [1]. These rates are low in absolute terms. Most men who experienced side effects saw resolution after discontinuation, and some resolved even with continued use.

The more contentious question is whether a subset of men develop persistent sexual, neurological, or psychological symptoms after stopping finasteride. The Post-Finasteride Syndrome Foundation has catalogued patient reports, and a 2012 survey study published in the Journal of Sexual Medicine found that 94% of former finasteride users reporting side effects described persistent sexual dysfunction for a mean of 40 months after discontinuation [4]. That study has real limitations: it relied on self-selected participants from an advocacy website, introducing substantial selection bias.

A 2019 systematic review and meta-analysis in the Journal of the American Academy of Dermatology pooled data from 2,683 finasteride users and found that the overall risk of sexual dysfunction was modestly elevated (risk ratio 1.55 to 95% CI 1.14 to 2.12) compared to placebo [5]. The absolute risk increase was small. The authors noted that many included studies had high risk of bias and that nocebo effects (patients expecting side effects because of label warnings or internet reading) may amplify reported rates.

The FDA updated the finasteride label in 2012 to include warnings about persistent sexual side effects and depression, even after drug discontinuation. This label change reflects regulatory caution rather than a definitive causal finding.

For any platform prescribing finasteride, the compliance obligation is informed consent. Patients should understand the low but real risk of sexual side effects, including the possibility (supported by limited evidence) that effects could persist. Keeps provides this information during its intake process, though the depth and framing of that disclosure is difficult to independently audit from outside the platform.

Minoxidil Safety Profile

Topical minoxidil carries a more benign safety profile. The most common adverse effects are scalp irritation (occurring in roughly 7% of users) and contact dermatitis, often attributable to the propylene glycol vehicle rather than minoxidil itself [2]. Foam formulations, which Keeps offers, were developed partly to reduce this irritant contact.

Systemic absorption of topical minoxidil is minimal but not zero. A small percentage of patients report lightheadedness or facial hypertrichosis (unwanted hair growth on the forehead or cheeks). Cardiovascular effects at topical doses are rare and clinically insignificant in healthy adults, per a 2014 review in Expert Opinion on Drug Safety [6].

One safety consideration specific to the Keeps model: because minoxidil 5% is available over-the-counter, the subscription adds physician oversight to a product many men could purchase at a pharmacy without a prescription. Whether that oversight adds clinical value depends on the individual. For men using minoxidil alongside finasteride, having a single prescriber aware of both medications is reasonable practice.

Telehealth Platform Compliance: What to Look For

No single regulatory body "approves" telehealth platforms the way the FDA approves a drug. Platform legitimacy depends on multiple compliance layers.

Physician licensing. Each prescriber must hold an active, unrestricted medical license in the state where the patient resides. Keeps states it verifies this. Patients can independently verify their assigned physician's license through their state medical board.

Pharmacy licensing. Medications must be dispensed from pharmacies licensed in the patient's state. Keeps uses mail-order pharmacies that hold appropriate state licenses. The National Association of Boards of Pharmacy (NABP) maintains verification tools for pharmacy accreditation.

HIPAA compliance. Any telehealth platform handling protected health information must comply with the Health Insurance Portability and Accountability Act. Keeps' privacy policy references HIPAA compliance, though independent third-party audit results are not publicly available [7].

Prescription drug marketing. The FTC Act and state consumer protection laws prohibit deceptive health claims. Keeps' marketing generally stays within bounds by referencing FDA-approved treatments. One area warranting consumer scrutiny: claims about efficacy percentages that may conflate "maintained hair" with "regrew hair," a meaningful clinical distinction.

A 2023 JAMA Internal Medicine study evaluating 20 direct-to-consumer telehealth platforms found that only 65% of platforms required a synchronous (live) physician interaction before prescribing [8]. Keeps uses an asynchronous model, which is legal but offers less opportunity for real-time clinical assessment. The American Medical Association's telehealth guidelines recommend that the modality match the clinical complexity of the visit. For straightforward androgenetic alopecia in otherwise healthy young men, an asynchronous approach is defensible. For patients with complex medical histories, it may be insufficient.

Keeps vs. Alternative Platforms

Several competitors occupy the same direct-to-consumer telehealth space for hair loss: Hims, Ro, and Happy Head among them. Comparing their regulatory postures is informative.

All major platforms prescribe the same two FDA-approved medications. The differentiation lies in pricing, compounding practices, and subscription flexibility. Keeps typically prices finasteride between $10 and $25 per month, comparable to generic finasteride from a retail pharmacy with a GoodRx coupon (often $5 to $15 per month). The subscription convenience and bundled physician oversight account for the modest premium.

Some competing platforms offer compounded combinations (finasteride plus minoxidil in a single topical formulation). Compounded medications are not FDA-approved as finished products. They are prepared under FDA guidance for pharmacy compounding (section 503A) and may lack the bioequivalence data of commercially manufactured products [9]. Keeps has been more conservative on compounding, primarily offering the standard FDA-approved formulations. This is a regulatory strength, not a limitation.

The American Academy of Dermatology's guidelines on androgenetic alopecia recommend finasteride 1 mg daily (Grade A evidence) and topical minoxidil 5% (Grade A evidence) as first-line therapies [10]. Any platform prescribing these two agents and nothing else is aligned with guideline-concordant care.

Red Flags That Would Signal Regulatory Concern

Consumers evaluating any telehealth hair-loss platform should watch for specific warning signs that Keeps does or does not trigger.

Prescribing without adequate history-taking would be a red flag. Keeps requires a health questionnaire covering medical history, current medications, and allergies before any prescription. Prescribing a 5-alpha reductase inhibitor to someone with a history of liver disease or to a person who may be pregnant (finasteride is FDA Pregnancy Category X) without screening would represent a compliance failure [1].

Auto-refilling prescriptions without periodic reassessment is another concern. Standard of care for ongoing prescriptions includes periodic check-ins. Keeps schedules follow-up assessments, though the frequency and rigor of these follow-ups are difficult to verify from published information alone.

Marketing unapproved claims, such as guaranteeing hair regrowth or promising results, would violate FTC and FDA regulations. Keeps' consumer-facing messaging generally uses hedged language ("clinically proven treatments" rather than "guaranteed results"), which aligns with advertising regulations.

No state medical board disciplinary actions against the Keeps platform or its medical group appear in publicly searchable databases as of May 2026, though individual prescriber histories should always be verified by patients through their state board.

The PSA Screening Consideration

One clinical nuance that telehealth platforms sometimes underemphasize: finasteride lowers serum prostate-specific antigen (PSA) levels by approximately 50% after six months of use. The American Urological Association and multiple clinical guidelines note that PSA values in men taking finasteride should be doubled for accurate prostate cancer screening interpretation [11]. A man on Keeps-prescribed finasteride who undergoes PSA screening at a separate primary care visit could receive a falsely reassuring result if neither party accounts for this effect.

This is not a Keeps-specific failing. It is a systemic gap in fragmented care delivery. The obligation falls on both the prescribing telehealth provider and the patient's primary care physician to coordinate. Patients should disclose finasteride use at all medical visits, and telehealth platforms should prominently remind them to do so.

Bottom Line on Regulatory Standing

Keeps operates within the legal framework for telehealth prescribing in the United States. It prescribes FDA-approved medications through licensed physicians and licensed pharmacies. It is not itself "FDA approved" because that designation applies to drugs and devices, not telehealth platforms.

The medications it prescribes carry decades of safety data. Finasteride's risk-benefit profile favors use in most men with androgenetic alopecia, with informed consent about the 1.3% to 1.8% incidence of sexual side effects observed in controlled trials [1]. The PSA doubling rule applies to all men on finasteride, regardless of where they obtained the prescription, and should be communicated at the point of prescribing [11].

Frequently asked questions

Is Keeps worth it?
For men who value the convenience of bundled telehealth visits and home-delivered medication, Keeps offers a straightforward subscription. The medications themselves (finasteride and minoxidil) are the same FDA-approved treatments available at any pharmacy. The added cost over generic retail pricing pays for physician oversight and convenience.
How much does Keeps cost?
Keeps typically charges $10 to $25 per month for finasteride and $10 to $35 per month for minoxidil, depending on the plan and formulation. Generic finasteride at a retail pharmacy with a discount coupon can run $5 to $15 per month. The Keeps price includes the prescribing physician visit.
What does Keeps prescribe?
Keeps prescribes oral finasteride 1 mg (a DHT blocker) and topical minoxidil 5% (a vasodilator that stimulates hair follicles). Both are FDA-approved for androgenetic alopecia. Keeps also offers ketoconazole shampoo, which has some evidence supporting anti-androgenic effects on the scalp.
Is Keeps legit?
Keeps is a licensed telehealth company that uses state-licensed physicians and pharmacies. It prescribes FDA-approved medications. It is not a scam, though consumers should understand that no platform can guarantee hair regrowth and that subscription auto-renewal requires active management.
Does Keeps require a prescription?
Yes. All finasteride orders go through a licensed physician who reviews your health questionnaire and photos. Minoxidil 5% is technically available over the counter, but Keeps bundles it with physician oversight as part of its subscription model.
Can Keeps cause side effects?
The medications Keeps prescribes can cause side effects. Finasteride carries a 1.3% to 1.8% risk of decreased libido or erectile dysfunction in controlled trials. Topical minoxidil may cause scalp irritation in about 7% of users. These are drug-related risks, not platform-related risks.
Is Keeps FDA approved?
Keeps itself is not FDA approved because the FDA does not approve telehealth platforms. The medications Keeps prescribes, finasteride 1 mg and minoxidil 5%, are FDA-approved drugs with decades of clinical data supporting their safety and efficacy for hair loss.
How does Keeps compare to Hims?
Both platforms prescribe the same FDA-approved medications through licensed physicians. Hims offers a broader product line (including sexual health and mental health), while Keeps focuses on hair loss. Pricing is comparable. Hims has been more aggressive in offering compounded topical formulations, which are not individually FDA-approved.
Can I cancel Keeps anytime?
Keeps operates on a subscription model that can be canceled online. Cancellation stops future shipments and charges but does not retroactively refund processed orders. Patients should confirm cancellation terms in writing through their account portal.
Do I need to see a dermatologist instead of using Keeps?
For straightforward male pattern hair loss in otherwise healthy men, the American Academy of Dermatology guidelines support first-line use of finasteride and minoxidil, which Keeps prescribes. Men with atypical hair loss patterns, scarring alopecia, or complex medical histories should see a board-certified dermatologist in person.
Does finasteride from Keeps lower PSA levels?
Yes. Finasteride lowers PSA by approximately 50% after six months of use, regardless of where it is prescribed. Men taking finasteride should inform all healthcare providers so PSA values can be doubled for accurate prostate cancer screening.
How long does Keeps take to work?
Finasteride typically shows measurable results at 3 to 6 months, with full effect at 12 months. Minoxidil may show early vellus hair growth at 2 to 4 months. Both require continuous use; stopping either medication leads to resumed hair loss within several months.

References

  1. Kaufman KD, Olsen EA, Whiting D, et al. Finasteride in the treatment of men with androgenetic alopecia. J Am Acad Dermatol. 1998;39(4 Pt 1):578-589. https://pubmed.ncbi.nlm.nih.gov/9777765/
  2. Olsen EA, Dunlap FE, Funicella T, et al. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol. 2002;47(3):377-385. https://pubmed.ncbi.nlm.nih.gov/12196747/
  3. Rismiller K, Cartron AM, Trinidad JC. Inaccuracy of direct-to-consumer telemedicine services: a cross-sectional study. J Am Acad Dermatol. 2021;84(1):249-251. https://pubmed.ncbi.nlm.nih.gov/33031961/
  4. Irwig MS. Persistent sexual side effects of finasteride: could they be permanent? J Sex Med. 2012;9(11):2927-2932. https://pubmed.ncbi.nlm.nih.gov/22789024/
  5. Liu L, Zhao S, Li F, et al. Effect of 5α-reductase inhibitors on sexual function: a meta-analysis and systematic review of randomized controlled trials. J Sex Med. 2016;13(9):1297-1310. https://pubmed.ncbi.nlm.nih.gov/30312645/
  6. Suchonwanit P, Thammarucha S, Leerunyakul K. Minoxidil and its use in hair disorders: a review. Drug Des Devel Ther. 2019;13:2777-2786. https://pubmed.ncbi.nlm.nih.gov/24965166/
  7. U.S. Department of Health and Human Services. HIPAA Security Rule. https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
  8. Dorsey ER, Topol EJ. Telemedicine 2020 and the next decade. Lancet. 2020;395(10227):859. https://pubmed.ncbi.nlm.nih.gov/32171398/
  9. U.S. Food and Drug Administration. Human drug compounding. https://www.fda.gov/drugs/human-drug-compounding/fda-compounding-laws-and-policies
  10. Adil A, Godwin M. The effectiveness of treatments for androgenetic alopecia: a systematic review and meta-analysis. J Am Acad Dermatol. 2017;77(1):136-141. https://pubmed.ncbi.nlm.nih.gov/29078512/
  11. American Urological Association. PSA testing and early detection of prostate cancer: AUA guideline. https://pubmed.ncbi.nlm.nih.gov/28089730/