Provider review
SkinnyRx Review: Under an Open FDA Letter, Still Advertising "FDA-Compliant Facilities"
SkinnyRx received an FDA warning letter on 20 February 2026 — a misbranding action under FD&C Act 502(a) and 502(bb) that named its compounded semaglutide and tirzepatide specifically. Nearly six months later there is no close-out, and its semaglutide product page still tells buyers the medication is "Prepared in FDA-compliant facilities and undergoes rigorous quality testing before reaching you." There is no such thing as an FDA-compliant facility in the sense that sentence implies: FDA does not certify compounding pharmacies as compliant, and a 503A pharmacy is licensed and inspected by its state board. The rest of the page is built the same way — "clinically supported ingredients", "rigorous quality testing", a "4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers)" — assertions shaped like evidence, none of which names a study, a laboratory, a lot or a pharmacy. This review discloses the letter rather than treating it as disqualifying, which is how this site handles every letter.
Compounded only
Phase 3 trials
Not named
February 2026
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Opens skinnyrx.com. A link is not a recommendation to take anything.
Provenance
What SkinnyRx actually dispenses
Regulatory category is the axis consumers are most reliably misled about, so it comes first. Every product below is sorted by what it legally is, not by what it costs.
Prepared by a state-licensed pharmacy against a prescription for a named patient. Compounded preparations are not FDA-approved and are not reviewed by FDA for safety, effectiveness or quality.
- Compounded Injectable Semaglutide — "As low as $199/mo*". The asterisk is not resolved on the product page.
- Compounded Injectable Tirzepatide — Priced from the intake; the injectable tirzepatide page does not render a standing figure without a quiz.
- Semaglutide Tablets / microdose programme — Not published on the microdosing page; the figure appears after the intake quiz.
Evidence
Is there a human trial at all?
One row per product, graded on how far the published human evidence goes for the use it is sold for — not for the molecule in general. A molecule with phase 3 evidence for one outcome has none for another, and that distinction is where peptide marketing lives.
2
Products with a human trial
Out of 3 reviewed here.
2
Registry records cited
Each read live from ClinicalTrials.gov, never from memory.
The comparison
What they claim, against what the trials show
Each claim below is quoted verbatim from SkinnyRx’s own page, with the page it came from. Grading a paraphrase would prove nothing. Every row is the verdict at a glance — tap it to open the quote, the trial registry entries, and the full note behind that verdict.
Compounded Injectable SemaglutideSemaglutide · Compounded (503A)Claim reaches past the trials
“Once-a-week injections of Semaglutide are designed with clinically supported ingredients to help support weight loss and metabolic health. […] Compounded semaglutide is a medication option that may be prescribed by a licensed provider and dispensed by U.S. state-licensed pharmacies. The medication helps control hunger, making you feel full longer and boosting your metabolism. Compounded semaglutide is Prepared in FDA-compliant facilities and undergoes rigorous quality testing before reaching you.”
Phase 3 trials
- NCT03548935 STEP 1 — Phase 3, completed, n=1,961. Tested the approved 2.4 mg product over 68 weeks. No compounded semaglutide from any seller has been through a registered trial.
The pharmacology is broadly right — semaglutide does reduce hunger and prolong satiety — and "may be prescribed by a licensed provider and dispensed by U.S. state-licensed pharmacies" is an accurate description of the pathway. Three phrases reach past what can be shown. "Prepared in FDA-COMPLIANT FACILITIES" describes a status FDA does not confer: 503A compounding pharmacies are licensed and inspected by state boards, and FDA neither certifies them as compliant nor approves what they make. That phrasing matters more here than it would elsewhere, because SkinnyRx is under an open FDA misbranding letter that names its compounded semaglutide specifically. "Clinically supported ingredients" gestures at evidence without naming any study. And "boosting your metabolism" is not what a GLP-1 receptor agonist does — the mechanism is appetite and gastric emptying, not metabolic rate.1
Compounded Injectable TirzepatideTirzepatide · Compounded (503A)Claim reaches past the trials
“Compounded tirzepatide […] Rigorous quality testing at FDA-compliant facilities. Licensed US medical providers review every application. […] 4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers). Money-back guarantee if you're not approved.”
Phase 3 trials
- NCT04184622 SURMOUNT-1 — Phase 3, completed, n=2,539. Tested the approved product at the highest tolerated dose over 72 weeks.
Same "FDA-compliant facilities" framing, and one additional claim worth isolating: "4.8-out-of-5 star rating on Trustpilot (HIGHEST AMONG GLP-1 PROVIDERS)". That is a comparative superiority claim about an entire market, published without a comparison set, a date or a method — and Trustpilot ratings move. SkinnyRx makes no efficacy claim specific to tirzepatide, which is why the underlying pharmacology is not in question; what is being sold alongside it is a set of trust signals that cannot be checked. ⚠ Its own patient-count figures also drift across the site: "Trusted by 50,000+ weight loss patients" on one page against "We've helped over 50,000 people" elsewhere — consistent, but neither is sourced.2
Semaglutide Tablets / microdose programmeSemaglutide · Compounded (503A)No trial supports this claim
“Microdose available. […] By stabilizing your hunger spikes and curbing emotional eating, microdosing makes the process feel like a natural lifestyle shift rather than a battle, allowing you to stop eating when comfortably full. […] appetite and manageable hunger without feeling "wiped out". The goal is steady, controlled progress.”
No human trial
The molecule has phase 3 evidence; this DOSING REGIMEN and this ROUTE do not. As of 10 August 2026, a ClinicalTrials.gov v2 search returns no completed trial of a sub-therapeutic "microdose" semaglutide regimen against any endpoint, and no registered trial of a compounded semaglutide TABLET. The approved oral semaglutide product tested in OASIS 4 is a specific 25 mg formulation with an absorption enhancer, not a compounded tablet, and the STEP programme tested injections titrated to a therapeutic target.
Two separate unevidenced things are combined here. Microdosing — a deliberately sub-therapeutic dose — has no completed trial against any endpoint, and the specific promise made for it is a side-effect claim: appetite control "without feeling 'wiped out'", steady progress rather than "a battle". That is a comparative tolerability claim, and tolerability at a reduced dose versus a therapeutic one is exactly the sort of thing only a trial comparing the two could establish. Separately, a compounded semaglutide TABLET has no registered trial at all; the approved oral product is a particular formulation with an absorption enhancer, and its results do not transfer to a compounded tablet.1
Dispensing chain
Who actually fills your prescription
Read the full account
No dispensing pharmacy is named anywhere on the site. What SkinnyRx publishes instead is a phrase that does not describe anything real: its compounded semaglutide is "Prepared in FDA-compliant facilities and undergoes rigorous quality testing before reaching you", repeated in its reasons-to-choose list as "Rigorous quality testing at FDA-compliant facilities". ⛔ FDA CONFERS NO SUCH STATUS. A 503A compounding pharmacy is licensed and inspected by its state board of pharmacy; FDA neither certifies it as compliant nor approves what it produces. A 503B outsourcing facility registers with FDA and is subject to inspection — but registration is not compliance certification either, and SkinnyRx claims neither category by name. The site states no compounding category at all. ⚠ This is the specific reason the phrasing is recorded here rather than passed over as marketing noise: SkinnyRx is under an open FDA misbranding letter that named its compounded semaglutide and tirzepatide, and "FDA-compliant facilities" is an implication of regulatory standing of exactly the kind such letters address. It does accurately describe the pathway elsewhere — "may be prescribed by a licensed provider and dispensed by U.S. state-licensed pharmacies" — which makes the FDA-compliant phrasing a choice rather than a misunderstanding.
Read on August 2026 from https://skinnyrx.com/products/semaglutide-injectable
Quality
Third-party testing, and what is published
Yes
Describes a testing regime
A described programme, not a document.
Certificate of analysis readable
No lot report a buyer can open
Read the full testing account
SkinnyRx asserts testing twice and publishes no result: "undergoes rigorous quality testing before reaching you" and "Rigorous quality testing at FDA-compliant facilities". No certificate of analysis, lot number, potency figure, sterility result, named laboratory or batch lookup appears anywhere, and no pharmacy is named to ask. `publishesTesting` is true and `coaPublic` false precisely to keep those apart — the company describes a regime, and a prospective customer can read no output of it. ⚠ The qualifier attached to the claim is the problem: "FDA-compliant facilities" is not a category FDA recognises or awards, so the assurance rests on a status that does not exist. ⚠ The other trust signals are the same shape. "Clinically supported ingredients" names no study. "4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers)" is a market-wide superiority claim with no comparison set, method or date. "Trusted by 50,000+ weight loss patients" is unsourced. No study, trial identifier or publication is cited anywhere on the site, for any product.
Read on August 2026 from https://skinnyrx.com/products/semaglutide-injectable
Licensing
Licensed to dispense, and where
Coverage
Not published — no state list, inclusion or exclusion, appears on the site
Read the full licensing claim
SkinnyRx publishes no coverage information. There is no state list, no map and no exclusion notice anywhere on the site, and `statesExcluded` is empty because naming exclusions would mean inventing them rather than because none exist. Clinical review is described only in general terms — "Licensed US medical providers review every application" and "Complete a 5-minute clinical intake to see whether clinician-guided treatment may be right for you" — with no medical group named, no individual clinician named and no licence number published. The corporate entity is Lean Rx, Inc., which is public knowledge chiefly because FDA's warning-letter index names it; the consumer site trades as SkinnyRx throughout. A money-back guarantee is offered "if you're not approved", which is a refund of a charge taken before the clinical decision rather than a satisfaction guarantee. ⚠ The whole site is a client-rendered application: a fetch without JavaScript returns roughly eight characters of text, so none of this is visible to a reader whose browser does not execute scripts.
Read on August 2026 from https://skinnyrx.com/products/semaglutide-injectable
Regulatory
The FDA warning letter
Issued February 2026
Lean Rx, Inc. dba SkinnyRx — 717989. Concerns marketing and labelling.
Read the full allegation
A misbranding action from FDA's Center for Drug Evaluation and Research under FD&C Act sections 502(a) and 502(bb), issued 20 February 2026 and posted 3 March 2026, indexed under the subject "False & Misleading Claims/Misbranded (Telehealth)". It names SkinnyRx's compounded semaglutide and tirzepatide specifically. It is one of a coordinated CDER telehealth sweep on that date which also reached Strut Health and other firms in this category. ⚠ Stated precisely: this is a claims-and-labelling action. The letter does not allege contamination, sterility failure or a product-quality defect, and this review does not suggest otherwise.
What has changed since
Checked 10 August 2026, and the answer is that the phrasing at issue is still there in a different form. SkinnyRx's product pages continue to state that its compounded semaglutide is "Prepared in FDA-compliant facilities and undergoes rigorous quality testing before reaching you", and repeat "Rigorous quality testing at FDA-compliant facilities" among its reasons to buy. FDA confers no "compliant" status on a compounding pharmacy, so the phrase implies a standing the facility does not hold — the same class of implication the letter addressed. ⚠ FDA's index shows NO CLOSE-OUT: column 6 is empty, so nearly six months on the letter remains open. The close-out column was validated in the same pass against Belmar's letter of 31 March 2023, which shows its 30 October 2023 close-out exactly where expected.
Assessment
What holds up, and what does not
- It describes the dispensing pathway accurately in at least one place: its products "may be prescribed by a licensed provider and dispensed by U.S. state-licensed pharmacies".
- It uses the word "compounded" plainly and repeatedly rather than obscuring what the product is — one company in this roster never uses it at all.
- The mechanism it describes for semaglutide — controlling hunger and prolonging fullness — is broadly correct for a GLP-1 receptor agonist.
Show 4 more
- It offers multiple formats (injectable, tablets, and the approved products Wegovy and orforglipron) rather than steering every patient to one compounded SKU.
- A money-back guarantee applies if a patient is not approved, so a declined applicant is not left out of pocket.
- Free overnight shipping is included rather than added at checkout.
- Clinical review is required before dispensing, described as a five-minute intake reviewed by licensed US providers.
- An FDA warning letter issued 20 February 2026 remains OPEN — no close-out nearly six months on. It is a misbranding action naming its compounded semaglutide and tirzepatide specifically.
- Its product pages still claim the medication is "Prepared in FDA-compliant facilities". FDA confers no such status on a compounding pharmacy.
- "Rigorous quality testing" is asserted twice, and no certificate of analysis, lot number, laboratory or result is published anywhere.
Show 9 more
- No dispensing pharmacy is named, and no compounding category — 503A or 503B — is stated.
- "Clinically supported ingredients" gestures at evidence while naming no study; nothing on the site cites a trial, a publication or a PubMed ID.
- "4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers)" is a market-wide superiority claim with no comparison set, method or date.
- "Boosting your metabolism" misdescribes how a GLP-1 works — the mechanism is appetite and gastric emptying, not metabolic rate.
- Its microdosing programme promises appetite control "without feeling 'wiped out'", a comparative tolerability claim no trial has tested.
- Compounded semaglutide tablets have no registered trial; the approved oral product is a different formulation with an absorption enhancer.
- No state coverage is published at all — no list, no map, no exclusions.
- The "as low as $199/mo*" asterisk is not resolved on the product page.
- The entire site is client-rendered: without JavaScript a reader sees roughly eight characters of text.
Verdict
The bottom line
SkinnyRx is under an open FDA warning letter for misbranding its compounded GLP-1s, and its product page still tells buyers the medication is "Prepared in FDA-compliant facilities" — a status FDA does not grant to anybody. That is the review in one sentence. This site discloses letters rather than treating them as disqualifying, and it applies that rule here as it does to the two other companies in this wave that carry one: a warning letter is a public regulatory communication about claims and labelling, not a finding about sterility or contamination, and nothing in this one alleges a product-quality defect. What the letter does make relevant is the pattern that produced it. Everything SkinnyRx offers in place of evidence is shaped like evidence and checks out as nothing: facilities that are "FDA-compliant", testing that is "rigorous" but never published, ingredients that are "clinically supported" with no study named, and a Trustpilot rating asserted to be the highest in its market with no comparison offered. The GLP-1 molecules work; every claim SkinnyRx layers on top of them is unverifiable.
Opens skinnyrx.com. A link is not a recommendation to take anything.
The letter, stated precisely
On 20 February 2026, FDA's Center for Drug Evaluation and Research issued a warning letter to Lean Rx, Inc. dba SkinnyRx, reference 717989. It was posted publicly on 3 March 2026 and is indexed under the subject "False & Misleading Claims/Misbranded (Telehealth)". It is a misbranding action under FD&C Act sections 502(a) and 502(bb), and it names SkinnyRx's compounded semaglutide and tirzepatide specifically. 3
Two things need saying immediately, because both are load-bearing.
It is a claims-and-labelling action. The letter does not allege contamination, sterility failure or any product-quality defect, and this review does not suggest otherwise. It belongs to a coordinated CDER telehealth sweep on that date which also reached other companies reviewed on this site.
It is still open. FDA's index carries a close-out column, and for this letter it is empty — nearly six months on. (The column was validated in the same pass against a known close-out: Belmar's letter of 31 March 2023 shows its 30 October 2023 close-out exactly where expected, so an empty cell here means what it appears to mean.)
This site discloses warning letters. It does not delist for them — only a shutdown, injunction or seizure would do that, and none has happened. Two other companies in this same review wave carry open letters and are treated identically.
*(A note for anyone re-checking: FDA's index returns two dates, posted 03/03/2026 and issued 02/20/2026. Both are real. Files elsewhere in this network cite one or the other and look as though they disagree — they do not.)*
Full analysis — 4 more sectionsAnd the sentence still on the page · Everything else shaped like evidence · The microdose promise · What this means if you are buying
And the sentence still on the page
Here is what SkinnyRx's compounded semaglutide page says today:
"Compounded semaglutide is Prepared in FDA-compliant facilities and undergoes rigorous quality testing before reaching you."
And, among its reasons to choose it:
"Rigorous quality testing at FDA-compliant facilities"
There is no such designation.
A 503A compounding pharmacy — which is what makes patient-specific compounded semaglutide — is licensed and inspected by its state board of pharmacy. FDA does not certify it, does not approve what it makes, and awards no "compliant" status. A 503B outsourcing facility does register with FDA and is subject to FDA inspection, but registration is not a compliance certification either, and SkinnyRx claims neither category by name. The site states no compounding category at all.
So the phrase asserts a regulatory standing that does not exist, on the product line named in an open FDA misbranding letter, at a company that describes the pathway correctly elsewhere on the same page — "may be prescribed by a licensed provider and dispensed by U.S. state-licensed pharmacies". It knows the accurate wording. It uses the other one in the quality claim.
Everything else shaped like evidence
Read SkinnyRx's reasons to buy in order:
"Free shipping directly to your door · Licensed US medical providers review every application · Rigorous quality testing at FDA-compliant facilities · No contracts or commitments – cancel anytime · 4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers) · Real, personalized support throughout your journey · Money-back guarantee if you're not approved"
Two of those are checkable and true — free shipping, and a refund if you are declined. The rest are the pattern.
"Rigorous quality testing" is asserted twice across the site. No certificate of analysis, lot number, potency figure, sterility result or named laboratory is published anywhere. No pharmacy is named to ask.
"Clinically supported ingredients", on the semaglutide page, gestures at a literature without naming one item of it. SkinnyRx cites no study, no trial, no publication and no PubMed ID anywhere on its site — for either molecule, both of which have large, genuine phase 3 programmes it could have pointed to. 1 2
"4.8-out-of-5 star rating on Trustpilot (highest among GLP-1 providers)" is a superiority claim about an entire market. No comparison set is given, no method, no date — and star ratings move.
And one line simply misdescribes the drug. The page says compounded semaglutide "helps control hunger, making you feel full longer and boosting your metabolism". The first two are right; a GLP-1 receptor agonist works on appetite signalling and gastric emptying. Boosting metabolic rate is not the mechanism.
The microdose promise
SkinnyRx offers a microdosing programme, described like this:
"By stabilizing your hunger spikes and curbing emotional eating, microdosing makes the process feel like a natural lifestyle shift rather than a battle… appetite and manageable hunger without feeling 'wiped out'. The goal is steady, controlled progress."
That is a comparative tolerability claim: a lower dose gives you the appetite control without the side effects of a full one. It is precisely the kind of claim only a trial comparing the two doses could establish, and no completed trial of a sub-therapeutic semaglutide regimen exists against any endpoint.
Separately, SkinnyRx sells compounded semaglutide tablets. No registered trial has tested a compounded oral semaglutide tablet. The approved oral product is a specific formulation built around an absorption enhancer, and its results do not transfer to a compounded one.
What this means if you are buying
The molecules work. Semaglutide and tirzepatide have large phase 3 programmes behind the approved products, and nothing in SkinnyRx's warning letter suggests a quality problem with what it dispenses.
What you cannot verify is anything SkinnyRx says about itself. No pharmacy is named, no compounding category is stated, no test result is published, no study is cited, and the one quality assurance offered — "FDA-compliant facilities" — describes a status that does not exist. Before buying, ask which pharmacy compounds it and under which category, and ask for a certificate of analysis.
Know that the company is under an open FDA misbranding letter naming these exact products, that it was issued in February 2026, and that no close-out has been recorded. That is a fact worth having, and it is not a reason on its own to walk away.
And treat the microdose page's promise of appetite control "without feeling wiped out" as marketing rather than a finding.
Questions
Frequently asked questions
Does the FDA warning letter mean SkinnyRx's products are unsafe?
The letter does not say that, and neither does this review. It was issued on 20 February 2026 by FDA's Center for Drug Evaluation and Research to Lean Rx, Inc. dba SkinnyRx, reference 717989, as a misbranding action under FD&C Act 502(a) and 502(bb), indexed under "False & Misleading Claims/Misbranded (Telehealth)". It names SkinnyRx's compounded semaglutide and tirzepatide specifically, and it concerns claims and labelling — it alleges no contamination, no sterility failure and no product-quality defect. It is one of a coordinated telehealth sweep on that date that also reached other companies reviewed on this site. What has not happened is a close-out: FDA's index shows column six empty nearly six months later, so the letter remains open. This site discloses letters and does not delist for them; only a shutdown, injunction or seizure would.
What is an "FDA-compliant facility"?
Nothing — FDA confers no such status, which is why this review flags the phrase. SkinnyRx's product page states its compounded semaglutide is "Prepared in FDA-compliant facilities and undergoes rigorous quality testing", and repeats "Rigorous quality testing at FDA-compliant facilities" among its reasons to buy. A 503A compounding pharmacy, which is what makes patient-specific compounded semaglutide, is licensed and inspected by its state board of pharmacy; FDA does not certify it or approve what it makes. A 503B outsourcing facility does register with FDA, but registration is not a compliance certification, and SkinnyRx names neither category. It describes the pathway accurately elsewhere on the same page — "dispensed by U.S. state-licensed pharmacies" — so the accurate wording was available.
Does SkinnyRx publish any test results?
No. It asserts "rigorous quality testing" twice and publishes no output of it: no certificate of analysis, no lot number, no potency figure, no sterility result, no named laboratory and no batch lookup. It also names no dispensing pharmacy and states no compounding category, so there is nobody a patient could approach for a record. This review records testing as claimed and no certificate as public, because those are different things and collapsing them would let an assertion read like a document. The site cites no study, trial identifier or publication anywhere either — including for the two GLP-1 molecules that have large phase 3 programmes it could have pointed to.
Is microdosing gentler than a full dose?
No trial has tested that, and it is the specific claim SkinnyRx makes. Its microdosing page promises appetite control "without feeling 'wiped out'" and "steady, controlled progress" rather than "a battle" — a comparative tolerability claim, asserting that a reduced dose keeps the benefit and loses the burden. Establishing that would require a trial comparing the two doses, and as of 10 August 2026 no completed trial of a sub-therapeutic semaglutide regimen exists against any endpoint. Separately, SkinnyRx sells compounded semaglutide tablets, and no registered trial has tested a compounded oral semaglutide tablet; the approved oral product is a specific formulation built around an absorption enhancer, whose results do not transfer.
Glossary
Key terms
Show definitions
- "FDA-compliant"
- Not a designation FDA awards. Compounding pharmacies are either state-licensed (503A) or FDA-registered outsourcing facilities (503B); neither status is "FDA compliance", and registration is not approval.
- Close-out
- A notice FDA issues when satisfied a firm has corrected the violations in a warning letter, published in its own column of the index. SkinnyRx's letter has none, so it remains open.
- Misbranding
- A charge under FD&C Act 502 concerning labelling and claims — what a product says about itself. It is a different allegation from adulteration, which concerns what is physically in the product.
Method
How we checked this
Non-product facts last checked August 2026. Read the editorial policy for the rules this page is held to.
Read our methodology
Claims read first-party
Every quoted claim was read off SkinnyRx's own pages on the date stamped against it, and the URL it came from is published beside it.
Trials read from the registry
Phase, status and enrolment come from ClinicalTrials.gov; identifiers and journals from PubMed's own records. Nothing here is cited from memory.
Absence claims bounded
Where we report that no trial exists, the page says what was searched, where, and when — never an unbounded claim that nobody has tested something.
Letters matched on full name
FDA letters are matched on the complete company name. A substring match would attach one firm's regulatory history to another with a similar name.
Sources
References
Show all 3 sources
- Wilding JPH, Batterham RL, Calanna S, et al. (2021). Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine 384(11):989-1002. https://pubmed.ncbi.nlm.nih.gov/33567185/
- Jastreboff AM, Aronne LJ, Ahmad NN, et al. (2022). Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine 387(3):205-216. https://pubmed.ncbi.nlm.nih.gov/35658024/
- US Food and Drug Administration (2026). Warning letter to Lean Rx, Inc. dba SkinnyRx, reference 717989 — issued 2026-02-20, posted 2026-03-03, Center for Drug Evaluation and Research, subject "False & Misleading Claims/Misbranded (Telehealth)", naming compounded semaglutide and tirzepatide. Close-out column empty as of 2026-08-10. Live warning-letter index queried with search_api_fulltext=skinnyrx; recordsFiltered=1, rows returned 1.. FDA warning letters. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters
Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.