Platform formulary · version 2026-08-12 · last changed Aug 16, 2026 · 08:30 UTC
What you cannot sell, and the provision that says so.
Every substance this platform has taken a position on is below, each with the authority that governs it. The refusals come first, because they are the part that costs money later: a brand that discovers at launch which of its products cannot lawfully be sold has already paid for the packaging. Nothing here is summarised — a refusal carries its reason in full, and a conditional entry carries every condition, because those conditions are the commercial terms. The same rows are served without a credential at /api/v1/formulary.
refused35 of 112 substances are refused outright
31 of them cite a federal provision that forecloses the substance for everyone, not only for us — no pharmacy, no state licence and no prescriber determination reaches them. 4 rest on approved labelling and our own clinical position rather than on a statutory bar. Those are ours, and the distinction is worth having: we will argue about them, and we will not argue about the others.
Why the refusals are refusals
Grouped by the provision each row cites, counted over the 35 refusals above. A substance frequently cites more than one and is counted under each, so these do not sum to the total — the provisions overlap because the refusals do. The concentration is worth naming: 14 of 14 entries in peptides and 3 of 3 entries in performance are refused, without exception.
Section 351 of the Public Health Service Act — 42 U.S.C. 262
5 refusals
A product licensed under section 351 is a biological product, and the compounding exemptions at sections 503A and 503B are unavailable to biologics altogether. Asking which prong of the bulk-substance test such a substance satisfies is the wrong question: the exemption does not reach it. A refusal on this ground is a statement about what the law permits, not about what we are willing to sell — no pharmacy, no state licence and no prescriber determination changes it.
The final 503A Bulks List — 21 CFR 216.23
12 refusals
Compounding from a bulk drug substance is lawful only where the substance has a USP or NF monograph, is a component of an FDA-approved drug, or appears on this list. Each row citing it is on none of those three footings, which leaves no lawful entry point at 503A regardless of which pharmacy is asked.
Unapproved new drug — 21 U.S.C. 355(a)
20 refusals
No drug may be introduced into interstate commerce without an approved application. A foreign approval, an orphan designation, a cosmetic listing or a food-ingredient conclusion is none of those things, and each is cited in the rows below as the reassurance it is not.
Essentially a copy of a commercially available drug — 21 U.S.C. 353a(b)(2)
8 refusals
Where an approved product exists, a compounded version with the same active ingredient at a similar strength by the same route falls outside the 503A exemption. Dosage form is not part of that test, which is why renaming a tablet a chew, a troche or a mint does not answer it.
Human growth hormone — 21 U.S.C. 333(e)
5 refusals
Distributing a growth hormone product for any use other than the treatment of a disease or recognised medical condition authorised by the Secretary is a federal criminal offence. This is the only ground on the formulary where the exposure is personal and custodial rather than regulatory.
The Controlled Substances Act and the DEA telemedicine rules
4 refusals
A scheduled substance carries prescribing, storage and telemedicine constraints on top of everything else, and several of these authorities carry an expiry date. A row resting on one of them is unstable by construction and is reviewed against the date, not against the calendar.
4 refusals cite none of these provisions: Compounded Hormone Pellets, Compounded Topical and Transdermal Progesterone, Estriol and Quetiapine (for off-label insomnia or anxiety). They rest on approved labelling and on our own clinical position, which makes them a policy rather than a legal bar. Marked as such, because a page that presented every refusal as compelled by statute would be overstating the ones that are.
Refused · 35
We will not sell it, and a brand cannot enable it. The database refuses the write and returns the reason below, so this is not a policy that depends on anyone remembering it.
Also asked for as oxandrolone, Anavar, stanozolol, Winstrol, nandrolone, Deca-Durabolin, boldenone, trenbolone, oxymetholone, methandrostenolone, Dianabol, prohormones
Why we refuse it
We do not sell anabolic-androgenic steroids other than prescribed testosterone for diagnosed hypogonadism. Oxandrolone, stanozolol, nandrolone, boldenone, trenbolone and the rest are Schedule III controlled substances, several have no current US approval at all, and none has an approved indication that matches what customers are actually asking for. Prescribing a Schedule III anabolic steroid for body composition is precisely the fact pattern that state boards and the DEA treat as prescribing outside the course of professional practice. A brand that wants a performance line will not get one here.
Some of these molecules have historical US approvals for narrow indications such as severe burns or hereditary angioedema. Those approvals do not support the body-composition use for which they are actually requested, and several have been withdrawn. Every one of them is a Schedule III controlled substance under the Anabolic Steroid Control Act, so the DEA telemedicine constraints in the testosterone rows apply on top of everything else.
Authority
21 U.S.C. 802(41) and 812(c) Schedule III (anabolic steroids); 21 CFR 1308.13(f); 21 U.S.C. 333(e) for growth-hormone-adjacent products; 21 U.S.C. 355(a) for the unapproved members of the class
Also asked for as LL-37, LL37, cathelicidin, KPV, lysine-proline-valine, alpha-MSH fragment 11-13
Why we refuse it
We do not sell LL-37 or KPV. Neither is FDA-approved, and neither has a lawful compounding basis under 503A or 503B — no USP monograph, no approved drug they are a component of, and no place on the bulks list. LL-37 in particular is sold for chronic infection and biofilm claims that no approved product carries, and dispensing it would put a brand in the position of treating serious infectious disease with an unapproved injectable.
Neither LL-37 nor KPV has a USP or NF monograph, either is a component of no approved drug, and neither is on the 503A Bulks List. Oral KPV capsules for gut inflammation and nebulised LL-37 are both routes with no approved analogue and no established safety data.
Also asked for as AOD9604, anti-obesity drug 9604, hGH fragment 176-191, growth hormone fragment
Why we refuse it
We do not sell AOD-9604. It has no FDA approval and no compounding basis — no USP monograph, not a component of an approved drug, not on the 503A Bulks List. It is a growth hormone fragment sold explicitly for fat loss, which puts it squarely in the territory that 21 U.S.C. 333(e) criminalises for growth hormone products distributed for non-approved uses. Suppliers sometimes point to a food-ingredient GRAS self-affirmation; that says nothing about lawful use as an injectable drug.
AOD-9604 is a fragment of human growth hormone (residues 176-191). It has no US approval, no USP monograph and no place on the 503A Bulks List. A self-affirmed GRAS conclusion for use in food, which is sometimes cited by suppliers, has nothing to do with whether it may be compounded into a drug.
Also asked for as alprazolam, Xanax, lorazepam, Ativan, clonazepam, Klonopin, diazepam, Valium, temazepam, Restoril, benzos
Why we refuse it
We do not prescribe benzodiazepines through this platform. These are lawful, approved drugs and this is our refusal rather than the law's — but the reasoning is not arbitrary. They are Schedule IV controlled substances carrying two boxed warnings: one on abuse, misuse, addiction, physical dependence and withdrawal, added class-wide in 2020, and one on concomitant use with opioids, where the outcome named in the label is profound sedation, respiratory depression, coma and death. A direct-to-consumer prescribing flow cannot reliably detect concurrent opioid use, an existing supply from another prescriber, or an escalating pattern, and withdrawal from benzodiazepines can be life-threatening, so a brand that stops shipping does harm too. On top of that, the entire controlled-substance telemedicine pathway rests on a temporary DEA flexibility that expires on 31 December 2026 with no finalised successor. Buspirone and hydroxyzine are on this formulary and are the anxiety products we support.
Compounding
503A · not applicable503B · not applicablebulk basis · component of an approved drug
Approved products are widely available and compounding is not the question — this row is a platform refusal of a lawful drug class, not a statement that the class is unlawful. In 2020 FDA required a class-wide boxed warning update covering the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions, in addition to the existing boxed warning about concomitant use with opioids and the resulting risk of profound sedation, respiratory depression, coma and death.
Authority
21 CFR 1308.14 (Schedule IV); FDA class-wide boxed warning requirement for benzodiazepines, 2020 (abuse, misuse, addiction, physical dependence, withdrawal reactions), in addition to the boxed warning on concomitant opioid use; 21 U.S.C. 829(e) (Ryan Haight); DEA telemedicine flexibility expiring 2026-12-31
Also asked for as BPC 157, Body Protection Compound 157, pentadecapeptide BPC 157, PL 14736
Why we refuse it
We do not sell BPC-157. There is no FDA-approved BPC-157 product and no lawful basis to compound one: it has no USP monograph, it is not a component of any approved drug, and it is not on the 503A Bulks List, which contains exactly six substances and has not been amended since February 2019. FDA's April 2026 removal of twelve peptides from the Category 2 list did not improve this position — those substances came off the list because the nominations were withdrawn, not because FDA cleared them, and none of them moved to Category 1. A pharmacy offering to compound BPC-157 is doing so with no statutory basis, and the finished product is an unapproved new drug.
Section 503A(b)(1)(A)(i) allows compounding from a bulk substance only if it complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List. BPC-157 satisfies none of the three, so there is no lawful entry point at 503A. It is also absent from the 503B bulks list, so an outsourcing facility is no help.
Authority
21 U.S.C. 353a(b)(1)(A)(i) (FDCA 503A bulk drug substance test); 21 CFR 216.23 (final 503A Bulks List — six substances, last amended February 2019); 21 U.S.C. 355(a) (unapproved new drug)
Also asked for as ED chew, sildenafil chew, tadalafil troche, hard mint, sildenafil tadalafil combination, PDE5 troche, sublingual sildenafil, compounded ED sublingual
Why we refuse it
We do not sell compounded ED chews, troches, hard mints or sublingual PDE5 products, including sildenafil-plus-tadalafil combinations. Under section 503A a compounded product is essentially a copy when it has the same active ingredient at a similar or substitutable strength by the same route — and dosage form is not part of that test, so calling a tablet a chew changes nothing. The historical justification for these products was that some patients cannot swallow a tablet; that argument ended on 16 December 2025 when FDA approved Vybrique, a sildenafil oral film, now marketed. There is a commercially available approved product in the exact format, so the compounded version is a copy of it. The narrow 503A allowance for four prescriptions per prescriber per calendar month, with refills counted separately, is not a scale channel and we will not build one on it.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The 503A copy test turns on the same active ingredient, the same or a similar strength (within about ten percent, or easily substitutable), and the same route — not the dosage form. An oral troche and an oral tablet are the same route. Combining sildenafil with tadalafil does not create a new article that escapes the test; it creates a product that is a copy of two approved drugs at once, with overlapping and additive PDE5 inhibition that no approved label supports. The 503A volume safe harbour of four prescriptions per prescriber per calendar month is not a business model, and each refill counts separately against it. In California the analysis is worse still: 16 CCR 1735(d) has no strength or route element, so a compounded product containing the same active ingredient is presumptively a copy there.
Authority
21 U.S.C. 353a(b)(2) and 353a(b)(1)(D) (four-prescription limit for copies where the prescriber determines a significant difference); 16 CCR 1735(d) and 1736(e) (California copy test, broader than FDA's); NDA 020895, NDA 021368, NDA 210858
Also asked for as pellet therapy, estradiol pellets, oestradiol pellets, BioTE, SottoPelle, hormone pellet insertion, subcutaneous hormone pellets, compounded testosterone pellets for women
Why we refuse it
We do not sell compounded hormone pellets to women, and we will not contract with a pellet-insertion network. There has never been an FDA-approved oestradiol pellet in the United States, and the only marketed pellet product of any kind is indicated in males. Be exact about what kind of refusal that makes it, because the two halves differ. For a compounded testosterone pellet FDA has already run the copy analysis — it told FarmaKeio Outsourcing in July 2021 that testosterone is a component of approved products including Testopel and that a compounded version must not be essentially a copy. For a compounded oestradiol pellet there is no approved comparator to copy, so nothing statutory bites and this is our clinical and commercial judgement; we will argue about it, and we are not going to borrow a legal bar we do not have. The judgement rests on FDA's own record. During a 2018 inspection FDA found 4,202 adverse events at a pellet marketer that had never been reported to the agency across five years, with information suggesting possible association with endometrial cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion; FDA could attribute only 61 of them, because the rest were recorded too poorly to attribute. A surveillance record that bad is itself the finding. NASEM recommended in 2020 that pellet dosage forms be treated as too difficult to compound, on delivery-mechanism complexity and the absence of bioavailability testing, and the 2019 global consensus statement on testosterone in women recommends against any preparation that produces supraphysiologic concentrations, naming pellets. The design objection is the one that ends it in a telehealth model: an implanted pellet cannot be removed or reduced, so a dose that runs high is managed by waiting months, and in women what is being waited out is virilisation, some of which does not reverse. Approved oestradiol and approved progesterone are on this formulary, and they can be stopped.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Start from the approval record, because it is stark. Exactly three drug products in Drugs@FDA have ever carried the dosage form 'pellet', only one of them is marketed, and it is Testopel — a testosterone pellet whose indications section is headed 'MALES'. There has never been an FDA-approved oestradiol pellet in the United States, and there is no approved pellet of any kind indicated for women. The regulatory position therefore splits, and both halves should be stated. For a compounded TESTOSTERONE pellet there is an approved comparator, and FDA has run that analysis in terms: its warning letter to FarmaKeio Outsourcing of 2021-07-29 recorded testosterone pellets compounded in eight strengths and reminded the facility that testosterone is a component of multiple approved drug products including Testopel, so the preparation must not be essentially a copy under 503B(a)(5). For a compounded OESTRADIOL pellet there is no approved comparator at all, so the copy test has nothing to bite on — it is simply an unapproved dosage form, which is precisely why this refusal is ours rather than the statute's, and we say so rather than borrowing authority we do not have. The judgement rests on FDA's own record. In a 2018 inspection of BioTE Medical, FDA investigators found 4,202 adverse events that had never been reported to the agency, accumulated between 2013 and 2018, with information suggesting compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion. FDA was able to attribute only 61 of those reports to compounded testosterone pellets, because the rest lacked the information needed to attribute them — that is the finding at its true strength and it should not be inflated. FDA has continued to inspect this dosage form: its warning letter to Empower Pharma of 2025-04-02 records incomplete cleaning validation on equipment used to compound implantable testosterone and oestradiol pellets. NASEM recommended in 2020 that all cBHT pellet preparations be considered for the Demonstrable Difficulties for Compounding lists, on delivery-mechanism complexity, insufficient guidance for compounders and the absence of required bioavailability testing, and its findings on hormone crystal pockets delivering an unintended bolus and on higher and more variable serum concentrations in women receiving pellets are the mechanism behind the adverse events. The 2019 Global Consensus Position Statement is blunter still: any testosterone preparation producing supraphysiologic concentrations, pellets named, is not recommended. The design objection stands alone: an implanted pellet cannot be withdrawn, so an overshoot is managed by waiting, and in women what is waited out is virilisation. Where the pellet contains testosterone, every Schedule III constraint in the testosterone for women row applies on top of this refusal.
Authority
FDA statement, 'Statement on improving adverse event reporting of compounded drugs to protect patients', 2019-09-09 (2018 inspection of BioTE Medical; 4,202 unreported adverse events accumulated 2013-2018; possible association with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion; 61 reports attributable to compounded testosterone pellets; pellets produced by Carie Boyd's Prescription Shop and AnazaoHealth Corporation and marketed by BioTe Medical, which was not registered as an outsourcing facility); FDA warning letter to FarmaKeio Outsourcing LLC, 2021-07-29, case 608257 (compounded testosterone pellets in eight strengths; testosterone is a component of multiple approved drug products including Testopel; 21 U.S.C. 353b(a)(5) and 353b(d)(2)); FDA warning letter to Empower Clinic Services LLC dba Empower Pharma, 2025-04-02 (cleaning validation incomplete for equipment used to compound implantable testosterone and estradiol pellets); NASEM 2020 consensus study recommending that all cBHT preparations in pellet dosage form be considered for the Demonstrable Difficulties for Compounding lists; Davis SR et al., 'Global Consensus Position Statement on the Use of Testosterone Therapy for Women', 2019 (preparations producing supraphysiologic concentrations, including pellets, not recommended); ANDA 080911 (Testopel, the only marketed pellet dosage form in Drugs@FDA, indications headed 'MALES'); no FDA-approved estradiol pellet exists in Drugs@FDA
Also asked for as compounded GLP-1, semaglutide from a compounding pharmacy, semaglutide sodium, semaglutide acetate, research semaglutide, oral compounded semaglutide, sublingual semaglutide
Why we refuse it
We do not sell compounded semaglutide in any form or by any route. The shortage that made compounded semaglutide briefly lawful was resolved on 21 February 2025, and FDA's enforcement discretion ended in 2025. With the shortage gone, compounding semaglutide is making essentially a copy of a commercially available drug, which section 503A does not exempt. Semaglutide is not on the 503B bulks list either, and on 1 May 2026 FDA proposed not to add it, so the outsourcing-facility route is closing rather than opening. Salt forms marketed as 'semaglutide sodium' or 'semaglutide acetate' are not the approved active ingredient and never had a basis. Oral and sublingual compounded semaglutide is a separate dead end: oral bioavailability is roughly one percent and depends on the absorption enhancer SNAC, which no compounder can reproduce — so the product does not work even setting the law aside. Approved semaglutide, including the oral Wegovy tablet approved in December 2025, is on this formulary and is the route we support.
The semaglutide shortage was resolved on 2025-02-21 and the associated enforcement discretion ended during 2025, which removes the 503A(b)(2) shortage route and restores the 'essentially a copy' bar in full. Semaglutide is not on the 503B bulks list, and on 2026-05-01 FDA proposed not to include semaglutide, tirzepatide or liraglutide — so the outsourcing-facility route is closing rather than opening. Salt forms (semaglutide sodium, semaglutide acetate) are not the approved active ingredient and have never had a lawful basis. Oral and sublingual compounded semaglutide is additionally futile: oral bioavailability is around 1 percent and is only achievable with the absorption enhancer salcaprozate sodium (SNAC), which a compounder cannot replicate.
Authority
21 U.S.C. 353a(b)(2) (essentially a copy of a commercially available drug); 21 U.S.C. 353b(a)(5) and 353b(d)(2) (503B bulks list and copy prohibition); FDA resolution of the semaglutide shortage, 2025-02-21; FDA proposed determination not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, 2026-05-01
Also asked for as compounded Mounjaro, compounded Zepbound, tirzepatide from a compounding pharmacy, research tirzepatide
Why we refuse it
We do not sell compounded tirzepatide. The shortage ended on 19 December 2024 and FDA's enforcement discretion ended in 2025, which restores the ordinary rule: compounding tirzepatide produces essentially a copy of a commercially available drug and falls outside the 503A exemption. Tirzepatide is not on the 503B bulks list, and FDA proposed on 1 May 2026 not to add it. At 503B the copy test is stricter still — it looks at dosage form and excipients as well as active ingredient, and unlike 503A there is no prescriber determination that can rescue it. The approved products are available and are on this formulary.
The tirzepatide shortage was resolved on 2024-12-19 and enforcement discretion ended in 2025. Tirzepatide is not on the 503B bulks list, and FDA proposed on 2026-05-01 not to include it. Note that under 503B prong (d)(2)(A) the copy test also takes account of dosage form and excipients, and no prescriber determination can rescue a 503B copy — the escape hatch that exists at 503A does not exist at 503B.
Authority
21 U.S.C. 353a(b)(2); 21 U.S.C. 353b(a)(5) and 353b(d)(2)(A); FDA resolution of the tirzepatide shortage, 2024-12-19; FDA proposed determination not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, 2026-05-01
Also asked for as progesterone cream, transdermal progesterone, compounded progesterone cream, natural progesterone cream, wild yam progesterone cream
Why we refuse it
We do not sell compounded topical or transdermal progesterone, and we will not accept it as the progestogen in any regimen. No FDA-approved transdermal or topical progesterone product exists. The approved route for protecting the endometrium of a woman taking systemic oestrogen is oral micronized progesterone, and that is where the evidence is. A compounded cream is not a weaker version of that — it is an unmeasured one, because no compounder is required to demonstrate that it reaches a protective serum concentration and in practice it does not. The failure is silent: a woman is told she is protected, has no symptom to report, and accumulates unopposed oestrogen exposure until hyperplasia or endometrial cancer presents. Endometrial cancer is the single risk FDA kept in the boxed warning of systemic oestrogen-alone products in 2025 and 2026 while removing the cardiovascular, breast cancer and dementia language, which is a fair measure of how settled it is. This refusal is ours rather than a statutory bar, and it is not negotiable: a brand that wants a cream instead of a capsule is asking us to accept an unmeasurable endometrial risk on a patient's behalf.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
This is the most dangerous single product a menopause operator will be offered, and the danger is not toxicity — it is silent failure. There is no FDA-approved transdermal or topical progesterone product for endometrial protection. Approved progesterone exists orally as micronized capsules, vaginally, and by injection; the approved oral capsule is what carries the evidence for protecting the endometrium of a woman taking systemic oestrogen. A compounded cream applied to the skin produces serum concentrations that are not comparable and that no compounder is required to demonstrate, so a woman can be told she is protected, feel entirely well, and be receiving unopposed oestrogen for years. The endpoint is endometrial hyperplasia and endometrial cancer, which is the one risk FDA declined to remove from the boxed warning of systemic oestrogen-alone products when it dismantled the rest of that warning in 2025 and 2026. NASEM's 2020 finding that cBHT lacks bioavailability evidence lands hardest here, because here the missing evidence is load-bearing rather than merely absent.
Authority
NDA 019781 (Prometrium, oral micronized progesterone — the approved route for endometrial protection); NDA 210132 (Bijuva, approved estradiol with micronized progesterone); no FDA-approved transdermal or topical progesterone product exists in Drugs@FDA; FDA drug alert of 2025-11-10 retaining the endometrial-cancer boxed warning for systemic oestrogen-alone products; NASEM 2020 consensus study on the absence of bioavailability evidence for compounded bioidentical hormone preparations
Also asked for as compounded vaginal estradiol, compounded estradiol suppository, vaginal hormone suppository, compounded vaginal cream, estradiol vaginal compound
Why we refuse it
We do not sell compounded vaginal oestrogen. Approved local vaginal oestradiol is commercially available as a cream, as two different inserts and as a ring, and approved conjugated oestrogens vaginal cream exists as well — which makes a compounded version essentially a copy of a commercially available drug, and section 503A does not exempt copies. Dosage form is not part of that test, so a compounded suppository or a custom cream base is the same article in law as the approved cream. The narrow allowance for a prescriber-determined significant difference is limited to four prescriptions per prescriber per calendar month, with each refill counting separately, and that is not something to build a line on. In California the position is worse still, because the state copy test has no strength or route element at all. If a patient genuinely cannot tolerate an excipient in every approved product, that is the compounded bioidentical hormone therapy row and its conditions, documented patient by patient — not a product line.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The bulk basis is not the problem and never was: oestradiol is a component of approved drugs. The problem is that approved local vaginal oestradiol exists in three dosage forms and across a range of strengths — a cream, two inserts and a ring — plus an approved conjugated oestrogens vaginal cream, so a compounded vaginal oestrogen has the same active ingredient at a similar or substitutable strength by the same route. That is the whole 503A copy test, and dosage form is not part of it, so recasting a cream as a suppository does not answer it. The 503A allowance for a prescriber-determined significant difference is capped at four prescriptions per prescriber per calendar month with refills counted separately, which is not a channel. California is stricter again: 16 CCR 1735(d) has no strength or route element, so the same active ingredient is presumptively a copy there. Compounded vaginal estriol is refused on the estriol row for separate reasons.
Authority
21 U.S.C. 353a(b)(2) (essentially a copy of a commercially available drug) and 21 U.S.C. 353a(b)(1)(D) (four-prescription limit where the prescriber determines a significant difference); ANDA 086069 (Estrace Cream); NDA 020908 (Vagifem); NDA 208564 (Imvexxy); NDA 020472 (Estring); NDA 020216 (Premarin Vaginal Cream); 16 CCR 1735(d) and 1736(e) (California copy test, broader than FDA's)
Also asked for as Priligy, dapoxetine hydrochloride, PE pill
Why we refuse it
We do not sell dapoxetine. It is approved in Europe and parts of Asia for premature ejaculation but has never been approved in the United States, so there is no lawful US supply — it cannot be dispensed as an approved drug and it has no compounding basis. Importing it for commercial resale is separately unlawful. Off-label SSRIs, principally paroxetine and sertraline, are the approved-product route for premature ejaculation and are on this formulary.
Dapoxetine is approved in a number of European and Asian markets for premature ejaculation. It has never been approved in the United States. A foreign approval is not an FDA approval, creates no 503A bulk basis, and does not make imported product lawful.
Authority
21 U.S.C. 355(a) (unapproved new drug); 21 U.S.C. 353a(b)(1)(A)(i); 21 U.S.C. 381(a) (import of unapproved drugs)
Also asked for as DTE, Armour Thyroid, NP Thyroid, natural desiccated thyroid, NDT, porcine thyroid, Nature-Throid, WP Thyroid, animal-derived thyroid
Why we refuse it
We do not sell desiccated thyroid extract under any name — Armour Thyroid, NP Thyroid, Nature-Throid, or a compounded equivalent. These are unapproved drugs and biological products under section 351 of the Public Health Service Act, and FDA has said in terms that the unapproved status covers products prepared by a licensed pharmacist in a state-licensed pharmacy or by an outsourcing facility, and that section 351 biologics are not eligible for the 503A or 503B compounding exemptions. There is therefore no lawful version of this product, compounded or commercial. Patients ask for it constantly and prescribers write it constantly; that does not change what it is. Levothyroxine, and liothyronine where genuinely indicated, are the approved answer.
FDA has stated that the unapproved status of animal-derived thyroid products includes ADT products prepared by a licensed pharmacist in a state-licensed pharmacy or by an outsourcing facility, and that biologics under section 351 are not eligible for the exemptions for compounded drugs under sections 503A and 503B. The compounding route was closed explicitly and by name — it is not an inference.
Authority
PHS Act 351 / 42 U.S.C. 262; 21 U.S.C. 353a and 353b; FDA statement that unapproved status of animal-derived thyroid includes products prepared by a licensed pharmacist in a state-licensed pharmacy or an outsourcing facility; 21 U.S.C. 355(a)
Also asked for as Spravato, esketamine nasal spray, S-ketamine
Why we refuse it
We do not dispense esketamine, and no telehealth platform can. Spravato is available only under a REMS that requires the dose to be administered in a certified healthcare setting, under the direct observation of a healthcare provider, with the patient monitored for at least two hours afterwards. The product is not dispensed to patients to take home — that restriction is the core of the REMS, not an administrative detail, and it exists because of sedation, dissociation and blood pressure elevation after dosing. A brand that wants a treatment-resistant depression pathway needs a certified in-person treatment centre partnership, which is a different business from a direct-to-consumer prescription.
Esketamine is approved for treatment-resistant depression and for depressive symptoms in major depressive disorder with acute suicidal ideation, and it is dispensed only under a REMS that requires administration in a certified healthcare setting under direct observation, with the patient monitored for at least two hours after dosing. Home dispensing is not a variation on the programme — it is the specific thing the REMS is designed to prevent. Application numbers were not verified for this revision.
Authority
Spravato (esketamine) REMS under 21 U.S.C. 355-1 (certified healthcare setting; direct observation; minimum two-hour post-dose monitoring; product not dispensed for home use); 21 CFR 1308.13 (Schedule III)
Also asked for as E3, oestriol, Biest, Triest, Bi-est, Tri-est, estriol cream, estriol vaginal cream, compounded estriol
Why we refuse it
We do not sell estriol in any form, and that includes Biest and Triest preparations, which contain it. There are no FDA-approved drugs containing estriol for human use in the United States — FDA states that plainly — so no regulator has ever found it safe or effective at any dose, and FDA has specifically rejected the claim that estriol is a safer form of oestrogen. FDA has gone further than silence: in the January 2008 action against seven pharmacy operations over compounded menopause hormone drugs, FDA wrote — in the warning letter we have read, issued to a compounding pharmacy in December 2008 — that it does not sanction the use of estriol in pharmacy compounding and will not exercise enforcement discretion for drug products containing it, and that an ingredient which is not a component of an approved drug needs an investigational new drug application held by the prescribing physician. Be precise about what kind of refusal this makes. It is not the categorical statutory bar that stops compounded hCG, and we will not dress it up as one: estriol sits in 503B Category 1 pending evaluation, and whether a 503A pharmacy has a lawful bulk-substance route turns on a USP monograph question that we have flagged for a pharmacist rather than answered. What we can say is that a hormone with no approved human product, no FDA finding of safety or effectiveness, an explicit FDA statement withholding enforcement discretion, a standing NASEM recommendation that FDA review it as too difficult to compound, and a marketing history built on a superiority claim FDA has rejected, is not a product we will put a brand's name on. Approved oestradiol, including local vaginal oestradiol, is on this formulary and does the same clinical work.
Estriol is the oldest flashpoint in compounded hormone therapy and the one where operators are most confidently wrong in both directions, so this note states each part separately. SETTLED: there is no FDA-approved drug containing estriol for human use in the United States, FDA says so in its own words, and every marketed human estriol product is therefore a compounded one that no regulator has found safe or effective at any dose. Estriol IS approved as an ANIMAL drug — oral tablets for urinary incontinence in spayed dogs, under a final rule of 2011-12-16 — so an unqualified claim that estriol is not FDA-approved is attackable and should be stated as 'no approved human drug'. DISTINCTIVE: FDA's 503B nomination list marks estradiol, estradiol cypionate, estrone, progesterone, testosterone and dehydroepiandrosterone as components of FDA-approved drugs and pointedly does NOT so mark estriol, which matches FDA's own 2008 words that estriol 'is not a component of an FDA-approved drug'. FDA'S STATED POSITION: on 2008-01-09 FDA acted against seven pharmacy operations over compounded menopause hormone drugs, and the warning letter it issued to Civic Center Pharmacy on 2008-12-16 in the same campaign says that FDA 'does not sanction the use of estriol in pharmacy compounding and will not exercise enforcement discretion with respect to drug products that contain estriol', and that a drug with an active ingredient that is not a component of an approved drug requires an IND obtained by the prescribing physician rather than by the pharmacy. We verified that language in the December letter; we did not obtain the text of the seven January letters. [confirm] UNRESOLVED, and this is the part that decides the 503A route: the three bulk-substance prongs of 503A(b)(1)(A)(i) are sequential, so a substance with a USP or NF monograph satisfies the first prong and never reaches the bulks list at all — which is exactly why estriol appears in none of FDA's 503A categories and not on the final list at 21 CFR 216.23, and why its absence there proves nothing either way. A USP-NF compounded preparation monograph for Estriol Compounded Vaginal Cream exists and a USP Estriol reference standard is sold; a bulk Estriol monograph existed in older USP-NF editions. [confirm] Whether a current bulk-substance monograph exists, and whether a compounded-preparation monograph can satisfy the prong at all, must be settled against the current USP-NF by a pharmacist. Counsel should separately reconcile FDA's 2008 enforcement position with the informal 2014 FDA Division of Drug Information communication reported by compounding counsel as saying the opposite; we could find no formal FDA document rescinding the 2008 position. [confirm] This row does not rest on either question, because the refusal below does not depend on the answer.
Authority
FDA press release 'FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs', 2008-01-09 (seven pharmacy operations; 'estriol ... is not a component of an FDA-approved drug and has not been proven safe and effective for any use'; 'No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown'); FDA warning letter to Civic Center Pharmacy, 2008-12-16 ('FDA does not sanction the use of estriol in pharmacy compounding and will not exercise enforcement discretion with respect to drug products that contain estriol'; IND obtained by the prescribing physician, not the pharmacy); FDA Office of Women's Health, 'Menopause & Hormones: Common Questions' ('There are no FDA-approved drugs containing estriol. Marketed drugs that contain estriol are compounded drugs, which are not FDA-approved.'); FDA 'Bulk Drug Substances Nominated for Use in Compounding Under Section 503B', updated 2025-03-21 (estriol in Category 1 and NOT marked as a component of an FDA-approved drug, unlike every other hormone in the group); FDA 'Bulk Drug Substances Nominated for Use in Compounding Under Section 503A', updated 2026-05-14 (estriol appears in no category); NASEM 2020 consensus study naming estriol among ten hormones recommended for PCAC review as a Demonstrable Difficulties for Compounding candidate; USP-NF compounded preparation monograph, Estriol Compounded Vaginal Cream, DOI 10.31003/USPNF_M10958_02_01; 76 FR 78149 (2011-12-16), 'Oral Dosage Form New Animal Drugs; Estriol'
Also asked for as GHK copper, copper tripeptide-1, copper peptide, GHK-copper
Why we refuse it
We do not sell GHK-Cu as a prescription or compounded product, in any route. It has no FDA approval and no lawful compounding basis. GHK-Cu is common in cosmetics, and that is the only lawful place for it — but the moment it is sold with claims about hair regrowth, wound healing or collagen synthesis, it stops being a cosmetic and becomes an unapproved new drug. Injectable GHK-Cu has no legal footing at all.
GHK-Cu appears widely as a cosmetic ingredient, and a cosmetic listing is not a drug pathway. There is no USP or NF monograph for GHK-Cu as a bulk drug substance, it is not a component of an approved drug, and it is not on the 503A Bulks List. A cosmetic that is marketed to affect the structure or function of the body becomes an unapproved new drug under 21 U.S.C. 321(g)(1)(C).
Also asked for as ipamorelin, CJC-1295, CJC1295, mod GRF 1-29, sermorelin, GHRP-2, GHRP2, pralmorelin, GHRP-6, GHRP6, hexarelin, ibutamoren, MK-677, MK677, ipamorelin CJC-1295 blend
Why we refuse it
We do not sell growth hormone secretagogues — ipamorelin, CJC-1295, sermorelin, GHRP-2, GHRP-6, hexarelin or MK-677 (ibutamoren). None has an FDA-approved product on the US market today, none has a USP monograph, and none is on the 503A Bulks List, so there is no lawful bulk substance to compound from. Sermorelin was approved once as Geref and was withdrawn in 2008; a withdrawn approval does not keep the compounding door open. Beyond the compounding problem, these are marketed for the exact purpose — raising growth hormone for body composition and anti-ageing — that 21 U.S.C. 333(e) makes a criminal offence when the product is a growth hormone product, and we will not build a commercial line that close to that statute.
None of these has a USP or NF monograph or appears on the 503A Bulks List. Sermorelin is the only one that was ever an approved drug (Geref), and that product was withdrawn from the US market in 2008 — the 503A 'component of an approved drug' prong requires a currently approved drug, so a withdrawn product does not revive the basis. MK-677 (ibutamoren) is a non-peptide secretagogue but fares no better: it was never approved for any indication.
Authority
21 U.S.C. 353a(b)(1)(A)(i); 21 CFR 216.23; 21 U.S.C. 355(a); 21 U.S.C. 333(e) (distribution of growth-hormone-effect products for non-approved uses)
Also asked for as human chorionic gonadotropin, HCG, Pregnyl, Novarel, Ovidrel, chorionic gonadotropin, hCG diet
Why we refuse it
We do not sell compounded hCG, and we do not support hCG for weight loss in any form. hCG is a biological product regulated under section 351 of the Public Health Service Act, and FDA has been explicit that biologics under section 351 are not eligible for the compounded-drug exemptions in sections 503A and 503B. That makes compounded hCG unlawful as a matter of law, not as a matter of our policy — there is no pharmacy, no state, and no prescriber determination that fixes it. Separately, hCG has never been shown to cause weight loss or fat redistribution, and approved hCG labelling says so directly.
hCG is a biological product licensed under section 351 of the Public Health Service Act. FDA has stated that biologics under section 351 are not eligible for the exemptions for compounded drugs under sections 503A and 503B. This is a categorical bar, not a bulks-list question — asking which prong of 503A(b)(1)(A)(i) hCG satisfies is the wrong question, because 503A does not reach it at all. Approved hCG products exist and are dispensed through ordinary licensed channels; the approved-product route is unaffected by this row, which addresses compounded hCG.
Authority
PHS Act 351 / 42 U.S.C. 262; BPCI Act 7002(e) 'deemed to be a licence' transition, effective 2020-03-23; 21 U.S.C. 353a and 353b (compounding exemptions unavailable to section 351 biologics); FDA statements on unapproved hCG products for weight loss
Also asked for as PEG-MGF, PEGMGF, MGF, mechano growth factor, IGF-1 LR3, IGF-1 DES, IGF1
Why we refuse it
We do not sell PEG-MGF, MGF or IGF-1 analogues such as IGF-1 LR3. None is FDA-approved and none has a lawful compounding basis. The only approved IGF-1 product, mecasermin, is a licensed biologic for a rare paediatric deficiency — and because it is licensed under section 351 of the Public Health Service Act, it cannot be compounded under 503A or 503B at all. These products are sold for muscle growth, they are banned in every drug-tested sport, and there is no version of the supply chain we would put a brand's name on.
PEG-MGF, MGF and the IGF-1 analogues sold to bodybuilders have no approvals, no USP monographs and no place on the bulks lists. Mecasermin (Increlex) is an approved recombinant IGF-1 for severe primary IGF-1 deficiency, is a licensed biological product, and is not a route to compounding these — biologics under PHS Act 351 are not eligible for the 503A or 503B exemptions.
Also asked for as kisspeptin, KP-10, metastin 45-54
Why we refuse it
We do not sell kisspeptin-10. It is an investigational peptide with no FDA approval and no lawful compounding basis. It is marketed to men's health brands as a testosterone or libido intervention on the strength of small academic infusion studies; there is no approved product, no established outpatient dose and no compounding pathway. Anything sold under this name is research material repackaged.
Also asked for as Xalatan, latanoprost lash serum, latanoprost for eyebrows, compounded latanoprost
Why we refuse it
We do not sell latanoprost for eyelash, eyebrow or scalp use, and we do not carry compounded latanoprost lash serums. Latanoprost is approved to lower intraocular pressure in glaucoma; it is not the approved eyelash drug. Bimatoprost, as Latisse, is FDA-approved for exactly this indication and is on our formulary, so there is an approved product available and no reason to run a glaucoma drop off-label into an unmonitored cosmetic programme. The risks are not theoretical either — prostaglandin analogues cause permanent iris darkening and periorbital fat atrophy, and a patient buying a lash product is not consenting to a glaucoma drug's side-effect profile.
Approved products
Xalatan · NDA 020597 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Latanoprost is approved for reduction of elevated intraocular pressure in glaucoma and ocular hypertension. It is not the approved eyelash drug — bimatoprost is. This row refuses the cosmetic use; it takes no position on latanoprost prescribed by an eye-care prescriber for its approved ophthalmic indication, which is outside the scope of a consumer aesthetics platform. Compounded latanoprost lash and brow serums are copies by the same ocular route.
Authority
NDA 020597 (Xalatan, approved for elevated intraocular pressure); NDA 022369 (Latisse — the approved product for eyelash hypotrichosis); 21 U.S.C. 353a(b)(2)
Also asked for as melanotan, melanotan 1, melanotan I, MT-1, melanotan 2, melanotan II, MT-2, MT2, tanning peptide
Why we refuse it
We do not sell melanotan I or melanotan II. Neither is an FDA-approved drug and neither has any lawful compounding basis — no USP monograph, not a component of an approved drug, not on the 503A Bulks List. They are sold almost entirely as unregulated injectables for tanning and libido, with documented reports of new and changing moles and melanoma in users, which is the opposite of what a dermatology-adjacent brand wants attached to its name. Afamelanotide (Scenesse) is a different, approved product for a rare porphyria and is not a route to selling melanotan.
Neither melanotan I nor melanotan II has a USP monograph or a place on the 503A Bulks List. Do not confuse melanotan I with afamelanotide (Scenesse), a separately approved implant for erythropoietic protoporphyria — the approved product is a different article, supplied through a restricted specialty channel, and its existence does not create a compounding basis for melanotan sold as a tanning or libido product.
Authority
21 U.S.C. 353a(b)(1)(A)(i); 21 CFR 216.23; 21 U.S.C. 355(a); FDA import alerts and warning letters on melanotan II products marketed as tanning agents
Also asked for as MOTS-c, MOTSc, epitalon, epithalon, epithalamin, humanin, SS-31, elamipretide
Why we refuse it
We do not sell MOTS-c, epitalon, humanin or SS-31/elamipretide. None is FDA-approved and none has a lawful compounding basis. These are sold on longevity and mitochondrial-function claims that have no approved indication and no adequate human evidence behind them, and they are almost always injectables — which means an operator would be shipping a sterile product made from a substance with no pharmacopoeial standard to a customer at home. That is the exact fact pattern behind the 2019 compounded glutathione injuries.
No approvals, no USP or NF monographs, no place on the 503A or 503B bulks lists. Elamipretide (SS-31) is in clinical development and is investigational, which is a bar to supply rather than a licence for it.
Also asked for as OTC hydroquinone, hydroquinone 2%, skin bleaching cream, fade cream, hydroquinone without a prescription
Why we refuse it
We do not sell over-the-counter hydroquinone, and no lawful US supply of it exists. The 2020 CARES Act reform of the over-the-counter monograph system deemed OTC hydroquinone products unapproved new drugs and misbranded; they came off the market on 23 September 2020, and FDA issued twelve warning letters on 19 April 2022 to firms still selling them. A supplier offering an OTC-strength hydroquinone cream today is offering an illegal product, whatever the strength on the label. Prescription hydroquinone remains lawful through the single approved product and is on this formulary.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
OTC hydroquinone products were deemed unapproved new drugs and misbranded by the CARES Act OTC monograph reform and have been off the market since 2020-09-23. FDA followed up with twelve warning letters on 2022-04-19 to firms still marketing them. Hydroquinone remains a component of an approved drug product, so a 503A bulk basis exists — but see the prescription hydroquinone row, where the copy analysis is what actually governs.
Authority
FDCA 505G (21 U.S.C. 355h), added by CARES Act 3851 — OTC hydroquinone deemed unapproved new drugs and misbranded, effective 2020-09-23; FDA warning letters to twelve firms, 2022-04-19; 21 U.S.C. 355(a) and 352
Also asked for as Seroquel, Seroquel XR, quetiapine fumarate, low-dose quetiapine for sleep
Why we refuse it
We do not prescribe quetiapine for sleep or anxiety. It is an antipsychotic with two boxed warnings — increased mortality in elderly patients with dementia-related psychosis, and suicidal thoughts and behaviours in young people — and it has no approved indication for insomnia at any dose. The low-dose sedative use that patients ask for is off-label, brings metabolic consequences that require weight, glucose and lipid monitoring, and carries a movement-disorder risk including tardive dyskinesia that can be permanent. There are two prescription insomnia drugs that are not controlled and have no boxed warning at all — ramelteon and low-dose doxepin — and both are on this formulary. Choosing an antipsychotic over either of those in a consumer sleep programme is indefensible.
Compounding
503A · not applicable503B · not applicablebulk basis · component of an approved drug
Quetiapine is an approved antipsychotic and is not a controlled substance; this row refuses the off-label consumer use, not the drug in psychiatric practice. It carries two boxed warnings — increased mortality in elderly patients with dementia-related psychosis, and suicidal thoughts and behaviours in children, adolescents and young adults — and requires metabolic monitoring for weight, fasting glucose and lipids. It has no approved indication for insomnia or for generalised anxiety.
Authority
FDA-approved quetiapine labelling: boxed warnings for increased mortality in elderly patients with dementia-related psychosis and for suicidal thoughts and behaviours; no approved indication for insomnia; 21 U.S.C. 352(f) and 331 (promotion of unapproved uses)
Also asked for as semax, N-acetyl semax, selank, N-acetyl selank, dihexa, DSIP, delta sleep-inducing peptide, cerebrolysin
Why we refuse it
We do not sell semax, selank, dihexa, DSIP or cerebrolysin. None is approved in the United States, and none has a lawful compounding basis: no USP monograph, no approved drug they are a component of, and no place on the 503A Bulks List. Semax and selank are approved in Russia, which is sometimes offered as reassurance — it is not a US approval and it creates no legal pathway here. Nasal sprays and injectables sold under these names are unapproved new drugs regardless of how the pharmacy describes them.
None of these has US approval, a USP or NF monograph, or a place on the 503A or 503B bulks lists. Semax and selank hold marketing authorisations in Russia; a foreign approval is not an FDA approval and creates no 503A basis whatsoever.
We do not sell retatrutide. It is an investigational drug that has not been approved in the United States or anywhere else — it is still in clinical trials. Outside a trial conducted under an IND, there is no lawful way to supply it: it has no compounding basis under 503A or 503B, and selling it is distribution of an unapproved new drug. Any supplier offering retatrutide today is sourcing grey-market API, and the brand carrying it inherits that exposure entirely.
Retatrutide is an investigational molecule that has never been approved anywhere. It has no USP monograph, is a component of no approved drug, and is on neither the 503A nor the 503B bulks list. There is no version of this that is lawful.
Authority
21 U.S.C. 355(a) (no drug may be introduced into interstate commerce without an approved application); 21 U.S.C. 353a(b)(1)(A)(i); 21 CFR 312 (investigational new drug requirements)
Also asked for as ostarine, MK-2866, enobosarm, ligandrol, LGD-4033, andarine, S-4, RAD-140, RAD140, testolone, YK-11, S-23, selective androgen receptor modulator
Why we refuse it
We do not sell SARMs — ostarine, ligandrol, andarine, RAD-140 or any of the rest. None has ever been approved by FDA for any use, none can be lawfully compounded, and none qualifies as a dietary ingredient, so there is no lawful channel at all. This is not a grey area that is trending in a good direction: SARM distribution has been a sustained criminal enforcement target for the Department of Justice, with prosecutions for introducing unapproved new drugs and misbranded products into interstate commerce. Documented liver injury and suppression of endogenous testosterone are the clinical picture on top of that.
No SARM has ever been approved by FDA for any indication. None has a USP or NF monograph and none is on the 503A or 503B bulks lists. Marketing them as dietary supplements is separately unlawful: they do not meet the definition of a dietary ingredient under 21 U.S.C. 321(ff).
Authority
21 U.S.C. 355(a) (unapproved new drug); 21 U.S.C. 331(d); 21 U.S.C. 321(ff) (not dietary ingredients); FDA public warnings on body-building products containing SARMs; sustained Department of Justice criminal enforcement
Also asked for as Adderall, amphetamine salts, dextroamphetamine, Vyvanse, lisdexamfetamine, methylphenidate, Ritalin, Concerta, ADHD stimulants
Why we refuse it
We do not prescribe Schedule II stimulants — Adderall, Vyvanse, methylphenidate or any equivalent — through this platform. The entire remote-prescribing model for controlled substances currently rests on a temporary DEA flexibility that expires on 31 December 2026. The special registration that the Ryan Haight Act contemplated was never finalised as a rule, and a patient at home does not satisfy any of the seven statutory exceptions in 21 U.S.C. 802(54). That means a Schedule II telehealth line has a hard, dated cliff with no known successor authority, and Schedule II carries the most enforcement attention of any tier, including federal prosecutions of telehealth prescribers. We are not willing to build an ADHD business whose legal basis has an expiry date on it, and neither should an operator.
Compounding
503A · not applicable503B · not applicablebulk basis · component of an approved drug
Approved products are widely available; this is a platform refusal of a lawful class, driven by the controlled-substance framework rather than by any compounding question. The temporary DEA telemedicine flexibility that currently permits remote controlled-substance prescribing expires on 2026-12-31, the special registration contemplated by the Ryan Haight Act was never finalised as a rule, and a patient sitting at home does not fit any of the seven statutory exceptions to the practice-of-telemedicine definition in 21 U.S.C. 802(54).
Authority
21 CFR 1308.12 (Schedule II); 21 U.S.C. 829(e) (Ryan Haight Act in-person medical evaluation requirement); 21 U.S.C. 802(54) (seven statutory exceptions defining the practice of telemedicine); DEA temporary telemedicine flexibility expiring 2026-12-31; special registration rule never finalised
Also asked for as hGH, HGH, human growth hormone, Genotropin, Norditropin, Omnitrope, Humatrope, growth hormone
Why we refuse it
We do not sell human growth hormone for anti-ageing, body composition, athletic performance or general wellness, and we will not onboard a brand that wants to. Distributing hGH for any use other than the treatment of a disease or recognised medical condition authorised by the Secretary is a federal criminal offence under 21 U.S.C. 333(e), carrying up to five years imprisonment — and up to ten if distribution is to someone under eighteen. This is the one substance on this formulary where the exposure is personal and criminal rather than regulatory. Approved somatropin for diagnosed growth hormone deficiency is a legitimate specialty-endocrinology product; it is not a direct-to-consumer telehealth product, and it is not what brands are asking us for when they ask about HGH.
Somatropin products are biological products licensed under section 351 of the Public Health Service Act following the March 2020 transition, so the 503A and 503B compounding exemptions are unavailable to them. Approved somatropin products exist for growth hormone deficiency and specific paediatric indications and are dispensed through specialty channels with endocrinology oversight; that is a different business from what this row refuses. UNCERTAIN: individual application numbers were not verified for this revision, so approvedProducts is empty rather than guessed.
Authority
21 U.S.C. 333(e) (distribution or possession with intent to distribute human growth hormone for any use other than the treatment of a disease or recognised medical condition, where authorised by the Secretary and pursuant to a physician's order, is a federal offence punishable by up to five years); PHS Act 351 / 42 U.S.C. 262
Also asked for as TB500, TB4, thymosin beta-4, thymosin beta 4, Tbeta4
Why we refuse it
We do not sell TB-500 or thymosin beta-4. There is no FDA-approved product and no lawful compounding basis — no USP monograph, not a component of an approved drug, and not on the 503A Bulks List. Material sold under these names is research-grade and typically labelled 'not for human use'; the seller is not making a drug, and the pharmacy dispensing it is not compounding lawfully. It is separately banned in competitive sport, which matters for any brand with athlete customers.
No USP or NF monograph, not a component of any FDA-approved drug, and not among the six substances on the final 503A Bulks List. Not on the 503B list either.
Authority
21 U.S.C. 353a(b)(1)(A)(i); 21 CFR 216.23; 21 U.S.C. 355(a); World Anti-Doping Agency Prohibited List (S2, growth factors) — relevant to any athlete-facing brand
Also asked for as Egrifta, Egrifta SV, Egrifta WR, tesamorelin acetate
Why we refuse it
We do not sell compounded tesamorelin. An FDA-approved tesamorelin product exists — Egrifta, for HIV-associated lipodystrophy — which means a compounded version is essentially a copy of a commercially available drug and is outside the 503A exemption on that basis alone. Tesamorelin is also a 44-amino-acid peptide, and products of that size became biological products licensed under section 351 of the Public Health Service Act in the March 2020 transition; biologics are not eligible for the 503A or 503B compounding exemptions at all. If a brand has a genuine lipodystrophy population, the answer is the approved product through a specialty channel, not a compounded copy.
Tesamorelin is unusual among the research peptides in that an approved product exists (Egrifta, for HIV-associated lipodystrophy), which would ordinarily supply the 'component of an approved drug' prong. Two things close that door. First, a compounded tesamorelin injection would be essentially a copy of Egrifta — same active ingredient, same subcutaneous route, comparable strength. Second, tesamorelin is a 44-amino-acid peptide, and protein products of that size were transitioned to biologics licences under the BPCI Act 'deemed to be a licence' provision on 2020-03-23, which would place it outside 503A and 503B entirely on the same reasoning that excludes hCG. UNCERTAIN: the deemed-BLA status of this specific product has not been confirmed against the FDA transition list for this revision. The conservative status is used until it is.
Authority
21 U.S.C. 353a(b)(2) (essentially a copy); PHS Act 351 / 42 U.S.C. 262 and BPCI Act 7002(e) 'deemed to be a licence' transition, effective 2020-03-23; 21 U.S.C. 353a(b)(1)(A)(i)
Also asked for as Ta1, thymalfasin, Zadaxin, thymosin a1
Why we refuse it
We do not sell thymosin alpha-1. It has never been approved by FDA, and it has no compounding basis — no USP monograph, not a component of any US-approved drug, not on the 503A Bulks List. Orphan-drug designation and approvals in other countries are sometimes cited as evidence it is legitimate; neither is an FDA approval and neither permits a US pharmacy to compound it. It is marketed for immune modulation, which is a claim we could not substantiate even if the supply were lawful.
Thymalfasin is approved in a number of countries outside the US and has US orphan-drug designation, neither of which is an FDA approval and neither of which creates a 503A basis. No USP monograph, not a component of a US-approved drug, not on the 503A Bulks List. FDA has previously identified thymosin alpha-1 as raising significant safety concerns in the compounding context.
Authority
21 U.S.C. 353a(b)(1)(A)(i); 21 CFR 216.23; 21 U.S.C. 355(a); FDA interim policy on compounding with bulk drug substances under section 503A
Also asked for as topical fin, finasteride spray, finasteride solution, topical finasteride and minoxidil, fin-min topical, compounded topical finasteride
Why we refuse it
We do not sell topical finasteride, in any strength, alone or blended with minoxidil. There is no FDA-approved topical finasteride product anywhere in the United States — every version on the market is compounded — and on 22 April 2025 FDA issued a Compounding Risk Alert specifically about it. That alert describes 32 adverse event reports between 2019 and 2024, states that absorption through the skin into the bloodstream is expected, and notes that most reports describe adverse events that continued to persist after the product was discontinued. In other words, the premise of the product, that going topical avoids systemic finasteride effects, is not supported. FDA also observed that approved finasteride tablets carry a coating which compounded topicals do not, which matters for handling exposure to others in the household. Separately, in California a topical finasteride is presumptively an unlawful copy of approved oral finasteride, because the state copy test looks only at the active ingredient and has no route element. Oral finasteride is approved, is on this formulary, and is the product we support.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
A 503A bulk basis exists because finasteride is a component of an approved drug, and it is that availability of a basis which makes this row a judgement call rather than an automatic bar under federal law. The judgement goes against it. FDA issued a Compounding Risk Alert on 2025-04-22 covering topical finasteride: 32 FAERS cases between 2019 and 2024, absorption through the skin into the bloodstream is expected, and most reports state that adverse events continued to persist after the product was discontinued. FDA also noted that approved finasteride tablets carry a coating that compounded topicals lack — relevant to handling exposure, including by pregnant partners. In California the copy analysis is independently fatal: 16 CCR 1735(d) has no route element, so a topical finasteride containing the same active ingredient as approved oral finasteride is presumptively a copy, and California imposes an independent duty on the pharmacist that the prescriber's determination does not discharge.
Authority
FDA Compounding Risk Alert, topical finasteride, 2025-04-22 (32 FAERS cases 2019-2024); 16 CCR 1735(d) and 1736(e) (California copy test and independent pharmacist duty); 21 U.S.C. 353a(b)(2); 21 U.S.C. 355(a)
Also asked for as spironolactone cream, topical spiro, spironolactone 5% topical, compounded topical spironolactone
Why we refuse it
We do not sell topical spironolactone. No FDA-approved topical spironolactone product exists, so every version is compounded, and none has controlled evidence for hair loss or acne. The marketing premise is that a topical route avoids the systemic antiandrogen and potassium effects that make oral spironolactone a monitored drug — that has not been established, and unquantified absorption is not the same as no absorption. In California the product is presumptively an unlawful copy of approved oral spironolactone, because the state copy test looks at the active ingredient alone with no route element, and it places an independent duty on the pharmacist that the prescriber cannot discharge. Oral spironolactone, with the potassium monitoring that goes with it, is on this formulary.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
There is no FDA-approved topical spironolactone product in the United States. A bulk basis exists because spironolactone is a component of an approved drug, so this is a copy-test and evidence judgement rather than an automatic federal bar — and it comes out against the product. Systemic absorption from a topical antiandrogen is not characterised, which means the hyperkalaemia and antiandrogen risks that justify monitoring on the oral product cannot be dismissed here, only ignored. California treats it as presumptively a copy of approved oral spironolactone, since 16 CCR 1735(d) has no route element.
Authority
16 CCR 1735(d) and 1736(e) (California copy test, no route element; independent pharmacist duty); 21 U.S.C. 353a(b)(2); 21 U.S.C. 355(a)
Next review
Feb 12, 2027
Permitted on conditions · 23
Sellable only once every condition below has been accepted, one by one. Accepting some of them is not accepting them: the enable is rejected until the last one is acknowledged, which is how a controlled-substance line stops going live by accident.
Dispense only the FDA-approved bremelanotide product; compounded PT-141 from any pharmacy or supplier is refused outright.
Restrict to the approved population and indication: acquired, generalised hypoactive sexual desire disorder in premenopausal women. Do not market it to men or as a general libido or performance product.
Screen and exclude uncontrolled hypertension and known cardiovascular disease; the approved labelling carries a transient blood pressure increase and heart rate decrease after each dose.
Counsel on nausea, which is the dominant reason for discontinuation, and on the labelled dosing limit of one dose in 24 hours and no more than eight doses per month.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
An FDA-approved bremelanotide autoinjector exists for acquired, generalised hypoactive sexual desire disorder in premenopausal women, which means the compounded PT-141 sold by wellness clinics is a copy of an approved product by the same subcutaneous route — outside the 503A exemption. It is also usually sourced as research-grade peptide API with no pharmacopoeial standard. The application number was not verified for this revision, so approvedProducts is empty rather than guessed.
Authority
FDA-approved bremelanotide autoinjector for acquired, generalised HSDD in premenopausal women (application number unverified in this revision); 21 U.S.C. 353a(b)(2); 21 U.S.C. 353a(b)(1)(A)(i)
Also asked for as cBHT, BHRT, bioidentical hormones, bio-identical hormone replacement, custom compounded hormones, multihormone troche, hormone balancing, compounded estradiol, compounded progesterone
9 conditions, all required
The operator must acknowledge in writing that no compounded bioidentical hormone preparation is FDA-approved, that FDA has therefore made no finding of safety or effectiveness for it, and that NASEM's 2020 consensus study found the evidence base insufficient.
Each compounded preparation must be documented against the copy test before it is enabled: the approved product it would otherwise be a copy of must be named, and the prescriber's determination of a significant difference for the individual patient must be recorded on the prescription. Preparations that duplicate Bijuva, Prometrium, an approved oestradiol patch, gel or vaginal product are refused.
The only two clinical circumstances this platform will support are the two NASEM identified: a documented allergy or intolerance to an ingredient in the FDA-approved product, and a dosage form that no approved product provides. 'The patient prefers compounded' is not one of them and must not be recorded as one.
A documented wind-down plan naming what happens to active patients if FDA acts on the NASEM recommendation and places any of the ten named hormones or pellet dosage forms on the Demonstrable Difficulties for Compounding lists, including a transition to approved products and a stated patient communication.
503A pharmacies only, patient-specific prescriptions only, no office stock, and no outsourcing-facility supply for these preparations. Certificate of analysis on file per lot from the dispensing pharmacy, with USP-grade sourcing evidenced.
No marketing that describes compounded hormones as natural, safer, superior to, or more individualised than FDA-approved hormone therapy, and no claim of 'hormone balancing' or 'optimisation'. FDA and NASEM have both addressed these claims directly and none of them is supported.
Salivary and serum hormone level testing must not be used to titrate therapy or as a marketing device; there is no validated target range for cBHT dosing and presenting one implies a precision the preparation does not have.
Multihormone preparations combining three or more hormones in a single article are refused. NASEM cautioned specifically that the more hormones in a formulation, the greater the potential for adverse effects.
Endometrial protection must be documented for every woman with an intact uterus receiving systemic oestrogen, using an oral progestogen with evidence behind it rather than a compounded topical preparation.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Read this row before enabling any compounded hormone line, because the risk here is not the bulk substance. Oestradiol, oestrone, progesterone and testosterone are components of FDA-approved drugs — FDA's own 503B nomination list marks each of them as such — so the 503A bulk-substance prong is satisfied and the bulks list is not the question. The binding constraints are two. First, the copy test: approved products now exist for almost every cBHT preparation an operator will be offered, including Bijuva for oestradiol with micronized progesterone, so the compounded version is essentially a copy of a commercially available drug and 503A does not exempt it. Second, the policy risk, which is real but must be stated accurately rather than as a rumour of a ban. NASEM delivered its FDA-sponsored consensus study on 2020-07-01, found the evidence for cBHT insufficient, recommended that prescribers restrict it to two circumstances, and recommended that FDA's Pharmacy Compounding Advisory Committee review ten bioidentical hormones — oestradiol, oestrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate and testosterone propionate — as candidates for the Demonstrable Difficulties for Compounding lists, together with pellet dosage forms. FDA has NOT acted on that recommendation by rulemaking. The only DDC proposed rule, published 2024-03-20 at 89 FR 19776 under Docket FDA-2023-N-0061, proposes the listing criteria and three categories that are not hormones at all — modified-release coated oral solids, liposome drug products and hot-melt-extrusion products — mentions no hormone anywhere in its text, and has not been finalised. So the position is a standing NASEM recommendation that FDA has not adopted, which is neither a ban nor a safe harbour, and a brand should plan for it the way it plans for any unfinalised policy: as something that can move without a transition period.
Authority
NASEM, 'The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use', delivered to FDA 2020-07-01 (FDA-sponsored; restrict to two circumstances; ten named hormones and pellet dosage forms recommended for PCAC review as Demonstrable Difficulties for Compounding candidates); 89 FR 19776 (2024-03-20), Docket FDA-2023-N-0061, proposed rule establishing DDC list criteria and the first three categories — none of them a hormone — comments closed 2024-06-18, not finalised; FDA 'Bulk Drug Substances Nominated for Use in Compounding Under Section 503B', updated 2025-03-21 (estradiol, estradiol cypionate, estrone, progesterone, testosterone and its esters marked as components of FDA-approved drugs); 21 U.S.C. 353a(b)(1)(A) and 353a(b)(2); 21 U.S.C. 353b(a)(5)
Also asked for as suvorexant, Belsomra, lemborexant, Dayvigo, daridorexant, Quviviq, DORA, orexin antagonist
4 conditions, all required
Controlled-substance prescribing authority established per state, PDMP checks at each fill, and a documented plan for 2026-12-31 when the DEA telemedicine flexibility expires.
Narcolepsy is a contraindication and must be excluded at intake.
Document next-day driving impairment counselling; the labelled risk persists into the following day even in patients who feel alert.
Screen for concurrent CNS depressants and for strong CYP3A4 inhibitors, which raise exposure and require dose adjustment or avoidance depending on the agent.
Approved products
Belsomra · NDA 204569 · approval date unverified
Dayvigo · NDA 212028 · approval date unverified
Quviviq · NDA 214985 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The DORAs are Schedule IV but carry no boxed warning, which places them between the z-drugs and the two non-controlled options. Clinically they are the better-tolerated modern choice; commercially the scheduling is what governs, because a Schedule IV product inherits the same DEA telemedicine exposure and the same 2026-12-31 expiry regardless of how benign its label is. Contraindicated in narcolepsy. Counsel on next-day somnolence and driving impairment, and on rare sleep paralysis and hypnagogic hallucinations.
Authority
NDA 204569 (Belsomra); NDA 212028 (Dayvigo); NDA 214985 (Quviviq); 21 CFR 1308.14 (Schedule IV); approved labelling carries no boxed warning; contraindicated in narcolepsy; DEA telemedicine flexibility expiring 2026-12-31
Also asked for as enclomiphene citrate, Androxal, trans-clomiphene
6 conditions, all required
The operator must acknowledge in writing that enclomiphene is not FDA-approved and that its availability rests on FDA enforcement discretion under 503A Category 1, which can be revoked by a single Federal Register publication.
A documented wind-down plan naming what happens to active patients if Category 1 status is withdrawn, including a transition pathway and a stated communication.
503A pharmacies only, for individually identified patients on valid prescriptions. No outsourcing-facility supply, since enclomiphene is not on the 503B bulks list, and no office stock.
Certificate of analysis on file for the API from the dispensing pharmacy, with USP-grade sourcing evidenced.
No marketing that describes enclomiphene as FDA-approved, as a proven alternative to testosterone, or as fertility-preserving TRT; none of those characterisations is supported by an approval.
Baseline and follow-up total testosterone, LH, FSH and haematocrit, since the clinical claim is restoration of endogenous production and it must be measured rather than assumed.
Compounding
503A · permitted503B · prohibitedbulk basis · bulks list
Enclomiphene is the most unstable permitted row on this formulary and should be treated as temporary. It is NOT FDA-approved: FDA's Pharmacy Compounding Advisory Committee voted against including it in 2022-06-08 and FDA never finalised the outcome, which left it in 503A Category 1 — the category FDA has said it does not intend to take action against pending resolution. Category 1 is enforcement discretion, not a legal right, and it can be withdrawn by a single Federal Register publication with no notice-and-comment period required to make the practical difference. It is not on the 503B list, so outsourcing facilities are not an option. A brand that builds a men's health business on enclomiphene is building on a policy position that FDA can reverse unilaterally, and it must plan for that.
Authority
FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Category 1 — enforcement discretion pending resolution); FDA Pharmacy Compounding Advisory Committee vote against enclomiphene citrate, 2022-06-08, never finalised; 21 U.S.C. 353a(b)(1)(A); 21 U.S.C. 353b(a)(2) (not on the 503B bulks list)
Also asked for as reduced glutathione, GSH, glutathione IV, glutathione injection, skin brightening drip
4 conditions, all required
Injectable glutathione is refused outright through consumer channels. This is not negotiable and it is the direct lesson of the February 2019 incident in which seven patients were harmed by a compounded glutathione injection with endotoxin up to five times the limit.
For any permitted oral or topical presentation: 503A pharmacies only, patient-specific prescriptions, and a certificate of analysis on file confirming pharmaceutical-grade API. API labelled 'Caution: Dietary Supplement' must never enter a compounded drug.
No skin-lightening or brightening claims; there is no approved glutathione product for that use and it is the indication most associated with the injectable harms.
The operator must acknowledge in writing that glutathione's compounding status rests on 503A Category 1 enforcement discretion, which FDA can withdraw.
Compounding
503A · permitted503B · prohibitedbulk basis · bulks list
Glutathione sits in 503A Category 1 — enforcement discretion, not a right — and is not on the 503B list. Its real importance to this formulary is as precedent rather than as a product. In February 2019 seven patients were harmed by a compounded glutathione injection in which endotoxin was measured at up to five times the permitted limit, and the root cause was that the active ingredient used to make a sterile injectable was labelled 'Caution: Dietary Supplement'. That single fact pattern — supplement-grade API entering a sterile injectable made for a wellness indication — generalises to every injectable longevity product a brand will be offered, including NAD+, peptides and vitamin drips. Any operator that cannot answer, in writing and per lot, what grade of API its pharmacy uses and what endotoxin testing was performed should not be selling injectables at all.
Authority
FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Category 1); FDA investigation of compounded glutathione injection adverse events, February 2019 (seven patients; endotoxin up to five times the limit; API labelled 'Caution: Dietary Supplement'); 21 U.S.C. 353a(b)(1)(A); USP General Chapter 797 (sterile compounding)
Also asked for as Accutane, Absorica, Claravis, Amnesteem, Myorisan, Zenatane, oral isotretinoin
6 conditions, all required
Prescriber, patient and pharmacy must be enrolled and certified in the iPLEDGE REMS before a single prescription is written; platform enablement is blocked until enrolment is evidenced.
For any patient who can become pregnant, the pre-treatment pregnancy test must be performed in a medical setting — this requirement is unchanged, so the brand must operate a real in-person testing pathway and cannot advertise the programme as fully virtual.
Two forms of contraception, or documented abstinence, for one month before, throughout, and one month after treatment, with the confirmatory testing and monthly authorisation windows enforced by the REMS calendar rather than by the brand's own scheduling.
Baseline and periodic lipids and hepatic function, with a named prescriber responsible for acting on results.
Depression and suicidality screening at intake and at each monthly visit, with a documented escalation path.
Re-verify the operative REMS requirements on or before 2026-11-15, when the modifications approved on 2026-02-09 take effect; do not build the flow against the modified requirements before that date.
Compounding
503A · prohibited503B · prohibitedbulk basis · component of an approved drug
Compounding is not the issue here; the REMS is. Isotretinoin is dispensable only through the iPLEDGE REMS, which controls prescriber certification, patient registration, pharmacy certification and the timing of pregnancy testing. The point most consequential to platform design: the requirement for the pre-treatment pregnancy test to be performed in a medical setting is unchanged. That means a fully virtual flow is not achievable for a patient who can become pregnant — an in-person step exists and cannot be designed around. REMS modifications were approved on 2026-02-09 but their implementation was delayed to 2026-11-15, so any launch planning that assumes the modified requirements must be re-verified against the operative REMS document on that date. Application numbers were not verified for this revision.
Authority
iPLEDGE REMS (isotretinoin shared system REMS) under 21 U.S.C. 355-1; REMS modifications approved 2026-02-09, implementation delayed to 2026-11-15; 21 CFR 208 (medication guides)
Also asked for as ketamine troche, sublingual ketamine, ketamine lozenge, at-home ketamine, Ketalar, ketamine hydrochloride, ketamine nasal spray compounded
7 conditions, all required
This is the highest-risk line on the formulary that we permit at all. A brand must accept every condition below in writing before it is enabled, and enablement is revocable.
Controlled-substance prescribing authority must be established for every state of operation, and the programme must have a documented plan for 2026-12-31, when the DEA telemedicine flexibility expires — including the option of orderly wind-down, since the special registration rule was never finalised and no successor authority exists.
A synchronous evaluation with a prescriber, not an asynchronous questionnaire, before the first prescription and at every dose escalation.
Exclusion criteria enforced at intake: psychosis or a history of psychotic disorder, uncontrolled hypertension, significant cardiovascular disease, a history of ketamine or other substance misuse, and pregnancy.
A monitor physically present for at-home dosing, plus a documented plan for the dosing session, since FDA's alert specifically identifies sedation and dissociation occurring without medical supervision as the hazard.
Quantity limits per dispense and a hard cap on cumulative supply, with PDMP checks at each fill — diversion, not efficacy, is the enforcement risk regulators act on.
State-level rules must be checked separately; several states impose requirements on at-home ketamine that exceed the federal position.
Approved products
Ketalar · NDA 016812 · approved Jan 1, 1970
Compounding
503A · permitted503B · copy riskbulk basis · component of an approved drug
The compounding analysis and the safety analysis point in opposite directions here, and it is important not to let the first reassure anyone about the second. Ketamine is a component of an approved drug, so the 503A bulk basis exists and the bulks list is not the operative question; and because the approved product is an injection for anaesthesia, a sublingual troche is a different route and therefore not an essentially-a-copy problem. That is where the good news stops. Ketalar was approved in 1970 for anaesthesia by the intravenous and intramuscular routes only — there is no approved oral, sublingual or nasal ketamine, and no approved psychiatric indication for ketamine itself. FDA issued a compounding risk alert on 2023-10-10 that names at-home telehealth use of compounded ketamine specifically, and notes that compounded ketamine products are not subject to a REMS and so may be less safe than the approved products. Ketamine is a Schedule III controlled substance, so the DEA telemedicine constraints described in the testosterone rows apply to it in full, including the 2026-12-31 expiry.
Authority
NDA 016812 (Ketalar, approved 1970, anaesthesia, IV and IM only); FDA compounding risk alert on compounded ketamine for psychiatric disorders, 2023-10-10 (naming at-home telehealth use; noting the absence of a REMS); 21 CFR 1308.13 (Schedule III); 21 U.S.C. 829(e) and 802(54) (Ryan Haight in-person requirement and telemedicine exceptions); DEA telemedicine flexibility expiring 2026-12-31
Also asked for as methylthioninium chloride, ProvayBlue, methylene blue drops, USP methylene blue
5 conditions, all required
Hard interaction block, enforced by the platform rather than by the prescriber's memory, against all serotonergic agents — SSRIs, SNRIs, tricyclics, MAOIs, triptans, tramadol, buspirone, St John's wort. Methylene blue is a potent MAOI and this combination causes serotonin syndrome.
The block must run across the whole patient record, not only the current cart. A brand selling both mental health and longevity lines is the specific failure mode this condition exists to prevent.
Screen and exclude G6PD deficiency, which carries a haemolysis risk, and exclude pregnancy.
Oral low-dose preparations only from a 503A pharmacy on a patient-specific prescription; no injectable methylene blue through a consumer channel.
No disease claims for cognition, mitochondrial function, long COVID or ageing; the only approved indication is acquired methaemoglobinaemia.
Approved products
ProvayBlue · NDA 204630 · approved Apr 8, 2016
Compounding
503A · permitted503B · copy riskbulk basis · component of an approved drug
The compounding position is genuinely defensible and it is not the risk. Methylene blue is a component of an approved drug, so the 503A bulk basis is satisfied and the bulks list is not the operative question; the approved product is an intravenous injection for acquired methaemoglobinaemia, so an oral low-dose preparation is a different route and a different indication rather than a copy. The highest-value screen is pharmacological, not regulatory: methylene blue is a potent monoamine oxidase inhibitor, and serotonin syndrome from combining it with serotonergic drugs is the documented harm. The telehealth longevity population overlaps heavily with the antidepressant population — the same platform frequently sells both — so a brand carrying methylene blue and SSRIs without a hard interaction block has built the exact conditions for that event. G6PD deficiency is the other hard exclusion, since methylene blue causes haemolysis in those patients.
Authority
NDA 204630 (ProvayBlue, approved 2016-04-08, for acquired methaemoglobinaemia); FDA Drug Safety Communication on serious central nervous system reactions from methylene blue with serotonergic psychiatric medications; 21 U.S.C. 353a(b)(1)(A)(i)
Also asked for as oral minoxidil, low-dose oral minoxidil, LDOM, Loniten, minoxidil 2.5mg, minoxidil tablets
5 conditions, all required
Documented cardiovascular screen before the first prescription: history of heart failure, pericardial disease, ischaemic heart disease, significant renal impairment or uncontrolled hypertension excludes the patient.
Written informed consent that specifically names the boxed warning — pericardial effusion, occasionally progressing to tamponade — and records that the use is off-label and the label directs close supervision, usually with a beta-blocker and a diuretic.
Dose ceiling set in the platform at low-dose hair-loss ranges; the antihypertensive dose range must not be prescribable through a consumer flow.
A named escalation route to a prescriber within 24 hours for oedema, rapid weight gain, dyspnoea, chest pain or resting tachycardia, with those symptoms surfaced to the patient as stop-and-call events.
No concurrent prescribing to a patient already on antihypertensive therapy without direct prescriber review rather than asynchronous review.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Oral minoxidil is approved for hypertension only. Hair use is off-label, which is lawful for a prescriber, but the boxed warning travels with the drug and does not become inapplicable because the intended use has changed. The boxed warning describes pericardial effusion, occasionally progressing to tamponade, and states that minoxidil must be administered under close supervision, usually concomitantly with a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload, and usually also with a diuretic to prevent serious fluid accumulation. The hair-loss doses used in practice are far below the antihypertensive range, which is the clinical argument for tolerability — but it is an argument a brand is making against its own product's labelling, and it should be documented as such. Approved tablets are commercially available, so compounded low-dose oral minoxidil is a copy question rather than a supply necessity; splitting approved tablets is the conventional route.
Authority
FDA-approved oral minoxidil labelling, boxed warning (pericardial effusion progressing to tamponade; close supervision, usually with a beta-adrenergic blocking agent and a diuretic); 21 U.S.C. 353a(b)(2). Application number not verified in this revision.
Also asked for as NAD, NAD+, NADH, nicotinamide adenine dinucleotide, NAD IV, NAD injection, NAD subcutaneous
5 conditions, all required
The operator must acknowledge in writing that NAD+ availability rests on unfinalised FDA policy, that FDA proposed to exclude it on 5 September 2019, and that finalisation would end the line without a transition period.
A documented wind-down plan for active patients if the 2019 proposal is finalised.
503A pharmacies only, patient-specific prescriptions only; no outsourcing-facility supply, since NAD is not on the 503B bulks list, and no office stock.
For any injectable form: certificate of analysis for each lot, sterility and endotoxin testing evidenced, and written confirmation that the API is not labelled or sourced as a dietary supplement. This condition exists because of the February 2019 compounded glutathione injuries, where endotoxin reached five times the limit and the API carried a dietary-supplement caution.
No disease claims. NAD+ has no approved indication for ageing, addiction, cognition, chronic fatigue or long COVID, and marketing it for any of them makes it an unapproved new drug regardless of the compounding position.
Compounding
503A · permitted503B · prohibitedbulk basis · bulks list
NAD and NADH currently sit in 503A Category 1, meaning FDA has said it does not intend to take action pending resolution — but FDA PROPOSED TO EXCLUDE them in a proposed rule dated 2019-09-05 that has never been finalised. That is the fact that should govern planning. An unfinalised proposal to exclude is not a safe harbour; it is a stated intention that has been pending for years and could be finalised at any time, removing the basis without a transition period. Not on the 503B list. The injectable route carries the added weight of the February 2019 compounded glutathione incident, whose root cause was API labelled for dietary supplement use going into a sterile injectable — a failure mode that generalises to every injectable longevity product, this one included.
Authority
FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Category 1); FDA proposed rule of 2019-09-05 proposing to exclude nicotinamide adenine dinucleotide and NADH, never finalised; 21 U.S.C. 353a(b)(1)(A); 21 U.S.C. 353b(a)(2)
Also asked for as Contrave, naltrexone bupropion extended release
5 conditions, all required
Hard stops in the intake for every bupropion contraindication: seizure disorder, current or prior bulimia or anorexia nervosa, abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptic drugs, and MAOI use within 14 days.
Hard stop for chronic opioid use or opioid agonist therapy; the naltrexone component precipitates withdrawal and this is an absolute contraindication.
Neuropsychiatric monitoring consistent with the boxed warning, including a documented depression and suicidality screen at intake and at follow-up, with a named escalation path.
Blood pressure and heart rate at intake and during titration; uncontrolled hypertension is an exclusion.
Apply the labelled stopping rule for inadequate weight loss at the assessment checkpoint rather than renewing indefinitely.
Approved products
Contrave · NDA 200063 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Not a controlled substance, which is its main structural advantage over phentermine-based options — no DEA exposure and no 2026-12-31 cliff. It carries a boxed warning for suicidal thoughts and behaviours, inherited from the bupropion component, and it brings bupropion's full contraindication set with it. That set must be enforced by the platform: seizure disorder; current or prior bulimia or anorexia nervosa; abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptics; MAOI use within 14 days; and, from the naltrexone component, chronic opioid use, which is an absolute contraindication and a precipitated-withdrawal risk.
Authority
NDA 200063 (Contrave); approved labelling boxed warning for suicidal thoughts and behaviours; contraindications including seizure disorder, bulimia or anorexia nervosa, abrupt discontinuation of alcohol or sedatives, MAOI within 14 days, and chronic opioid use; not scheduled under 21 CFR 1308
Also asked for as NR, Niagen, nicotinamide riboside chloride
3 conditions, all required
Dietary supplement channel only; no prescription or compounded presentation, because no 503A or 503B basis exists.
Structure-function claims only, with the required disclaimer; no disease claims, including claims about ageing, mitochondrial disease or neurodegeneration.
Supplier must evidence that the ingredient is within the scope of the GRAS notice and the applicable use levels.
Nicotinamide riboside is the cleanest of the three NAD precursors and the one to steer a longevity brand toward. It is a lawful dietary ingredient with a GRAS notice on file — GRN 000635 — which is a settled position rather than an unfinalised policy or a reversal. What it does not have is any compounding route: no USP monograph as a bulk drug substance, not a component of an approved drug, not on the 503A or 503B bulks lists. So it is a supplement, cleanly, and nothing else.
Authority
GRAS Notice GRN 000635 (nicotinamide riboside chloride); 21 U.S.C. 321(ff) and 350b (dietary ingredient and new dietary ingredient provisions); 21 U.S.C. 353a(b)(1)(A)(i) (no compounding basis)
Also asked for as nicotinamide mononucleotide, beta-NMN, NMN supplement
4 conditions, all required
Dietary supplement channel only. NMN must not be prescribed, compounded, or dispensed through a pharmacy as a drug — there is no 503A or 503B basis for it and the 2025 reversal did not create one.
New dietary ingredient notification status must be confirmed for the specific ingredient and supplier before any product is listed.
Structure-function claims only, with the required disclaimer. Any claim to treat, prevent or mitigate a disease — including ageing framed as a condition — converts the product into an unapproved new drug.
No injectable NMN in any form or through any channel.
NMN is the row where FDA reversed itself, and the reversal is narrower than the market has read it. In 2022 FDA took the position that NMN was excluded from the dietary supplement definition because it had been authorised for investigation as a new drug. In a response dated 2025-09-29 FDA determined that NMN is NOT excluded from the dietary supplement definition, superseding the 2022 position. That restores the supplement pathway — and only the supplement pathway. NMN remains a new dietary ingredient requiring notification, and it has no compounding pathway at all: no USP monograph, not a component of an approved drug, not on the 503A or 503B bulks lists. A prescription or compounded NMN product has no basis, before or after the reversal.
Authority
FDA response dated 2025-09-29 determining that nicotinamide mononucleotide is not excluded from the dietary supplement definition, superseding the 2022 position; 21 U.S.C. 321(ff)(3)(B) (exclusion provision); 21 U.S.C. 350b (new dietary ingredient notification); 21 U.S.C. 353a(b)(1)(A)(i)
Also asked for as Adipex-P, Lomaira, phentermine hydrochloride, phentermine 37.5
6 conditions, all required
Controlled-substance prescribing authority per state, PDMP query at initiation and at each renewal, and a documented plan for 2026-12-31 when the DEA telemedicine flexibility expires.
State rules must be implemented per state at their own stringency — Ohio Admin. Code 4731-11-04 is the benchmark, requiring documented failure of non-pharmacologic weight-loss attempts, an examination, a twelve-month PDMP query, and BMI of at least 30 or at least 27 with a comorbidity.
Enforce the stop rule, not only the start rule: where the state requires it, treatment must be discontinued if the patient has not lost five percent of body weight within three months. This must be enforced by the platform, because a subscription model has no incentive to enforce it.
Duration limits consistent with the short-term approved indication; indefinite refills are inconsistent with the label.
Exclusions enforced at intake: cardiovascular disease, uncontrolled hypertension, hyperthyroidism, glaucoma, agitated states, a history of drug abuse, pregnancy or breastfeeding, and MAOI use within 14 days.
Blood pressure and heart rate captured at intake and at renewal.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Phentermine is approved for short-term use — a few weeks — as an adjunct to caloric restriction in exogenous obesity. It is a Schedule IV controlled substance, so the DEA telemedicine exposure and the 2026-12-31 expiry apply. What makes this row operationally distinctive is the state overlay, which is heavier here than anywhere else on the formulary and is not optional. Ohio Administrative Code 4731-11-04 is the clearest example: it requires documented failure of non-pharmacologic attempts at weight loss, an examination, a query of the prescription monitoring programme covering the preceding twelve months, a BMI of at least 30 or at least 27 with a comorbidity, and it forbids continuing treatment if the patient has not lost five percent of body weight within three months. A national programme must implement the strictest applicable state rule per state, not a single federal-floor policy. Application numbers were not verified for this revision.
Authority
21 CFR 1308.14 (Schedule IV); FDA-approved phentermine labelling (short-term adjunct in exogenous obesity); Ohio Admin. Code 4731-11-04 (documented failure of non-pharmacologic attempts, examination, twelve-month PDMP query, BMI at least 30 or at least 27 with comorbidity, discontinuation if five percent weight loss is not achieved in three months); DEA telemedicine flexibility expiring 2026-12-31
Also asked for as Qsymia, phentermine topiramate extended release
5 conditions, all required
Dispensing pharmacies must be certified under the active Qsymia REMS before the line is enabled; confirm certification in writing rather than assuming the REMS has been retired.
Negative pregnancy test before initiation and monthly during treatment for any patient who can become pregnant, with effective contraception documented.
Controlled-substance prescribing authority per state, PDMP checks, and a documented plan for 2026-12-31 when the DEA telemedicine flexibility expires.
Follow the labelled stopping rules for inadequate weight loss at the titration checkpoints, and taper rather than stop abruptly because of the topiramate component.
Monitor resting heart rate, and screen for glaucoma, metabolic acidosis risk and concurrent carbonic anhydrase inhibitors.
Approved products
Qsymia · NDA 022580 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Qsymia has an ACTIVE REMS — this is the detail most often assumed away, because several obesity REMS programmes have been retired and people generalise. The Qsymia REMS was modified rather than eliminated and is now built around pharmacy certification. The clinical driver is topiramate teratogenicity: a significantly increased risk of orofacial clefts in infants exposed in the first trimester. Schedule IV via the phentermine component, so the DEA telemedicine constraints apply.
Authority
NDA 022580 (Qsymia); active Qsymia REMS under 21 U.S.C. 355-1, now pharmacy-certification-based; approved labelling (fetal toxicity — increased risk of orofacial clefts with first-trimester exposure); 21 CFR 1308.14 (Schedule IV)
Also asked for as sirolimus, Rapamune, rapamycin for longevity, low-dose sirolimus
6 conditions, all required
Prescribers must be individually credentialed for this line and the brand must document why each prescriber meets the labelling expectation of experience in immunosuppressive therapy; a general telehealth prescriber panel does not satisfy this.
Written informed consent naming the boxed warning in full — immunosuppression, increased susceptibility to infection, possible development of lymphoma — and stating explicitly that longevity use is off-label with no approved indication and no outcome evidence in healthy adults.
Baseline and periodic laboratory monitoring including complete blood count, lipids, hepatic and renal function, with a named prescriber accountable for acting on results.
Live vaccine avoidance, infection-symptom escalation instructions, and a documented plan for perioperative and wound-healing interruption.
Hard interaction block for strong CYP3A4 and P-glycoprotein inhibitors and inducers, including grapefruit.
No marketing that presents rapamycin as an anti-ageing or longevity drug; there is no approved indication and such claims are promotion of an unapproved use.
Approved products
Rapamune · NDA 021110 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for prophylaxis of organ rejection in renal transplant and for lymphangioleiomyomatosis, and available commercially, so the compounding question is a copy question rather than a supply one. The tension that a brand must confront directly is between the label and the channel: Rapamune carries a boxed warning covering immunosuppression with increased susceptibility to infection and the possible development of lymphoma, and the labelling states that it should be used by physicians experienced in immunosuppressive therapy and in the management of the relevant transplant patients. Direct-to-consumer longevity prescribing by a general telehealth prescriber is the opposite of that instruction. The intermittent weekly low-dose longevity protocol has no approved indication and no adequate outcome evidence in healthy people; a brand offering it is running an uncontrolled experiment with an immunosuppressant, and should be honest with itself about that before it is honest with a regulator.
Authority
NDA 021110 (Rapamune); approved labelling boxed warning (immunosuppression, increased susceptibility to infection, possible development of lymphoma; to be used by physicians experienced in immunosuppressive therapy); 21 U.S.C. 352(f) and 331 (promotion of unapproved uses)
Also asked for as Aldactone, spiro, spironolactone 50mg, spironolactone 100mg, CaroSpir
5 conditions, all required
Laboratory access must be live before the line is enabled: baseline serum potassium and creatinine, repeated after dose initiation or escalation and periodically thereafter, with results returning to a prescriber who can act on them.
Hard exclusions enforced in the intake: existing hyperkalaemia, Addison's disease, significant renal impairment, and concurrent potassium supplements or potassium-sparing diuretics.
Interaction screen at every renewal for ACE inhibitors, angiotensin receptor blockers, NSAIDs, trimethoprim and potassium-containing salt substitutes, all of which raise potassium.
Pregnancy screening and contraception counselling documented, given the antiandrogenic effect on a male foetus.
Do not market spironolactone as FDA-approved for acne or hair loss; both are off-label uses of a drug approved for other indications.
Approved products
Aldactone · NDA 012151 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Two corrections that repeatedly appear in operator diligence. First, the current spironolactone label carries NO boxed warning — the historical tumorigenicity boxed warning was removed, and a brand that plans around a boxed warning here is planning around a document that no longer exists. Second, because spironolactone is a component of an approved drug, the 503A bulks list is irrelevant to it. The actual constraint is clinical and operational: spironolactone is a potassium-sparing diuretic, and hyperkalaemia is the risk that governs the programme. That implies laboratory access, which is the real cost driver — a brand that cannot order and act on a potassium and creatinine result cannot run this line properly. Spironolactone is also a teratogen risk in male foetuses and should not be used in pregnancy.
Authority
NDA 012151 (Aldactone); current FDA-approved spironolactone labelling (no boxed warning; hyperkalaemia warnings and monitoring); 21 U.S.C. 353a(b)(1)(A)(i)
Also asked for as Depo-Testosterone, testosterone cypionate, testosterone enanthate, Xyosted, TRT injection, test cyp
7 conditions, all required
Controlled-substance prescribing authority must be established and evidenced for every state of operation, with PDMP checks at initiation and at each fill.
A documented plan for 2026-12-31, when the DEA telemedicine flexibility expires. There is no finalised successor: the special registration rule was never completed, and a patient at home satisfies none of the seven statutory exceptions in 21 U.S.C. 802(54). The plan must include orderly wind-down as an option rather than an assumption that the flexibility is extended again.
Diagnosis established on at least two morning serum testosterone measurements consistent with the approved indication, with LH, FSH and prolactin as clinically indicated — not on symptoms alone.
Baseline and periodic haematocrit, with a defined threshold for dose reduction, phlebotomy or discontinuation; erythrocytosis is the most common cause of harm in an unmonitored programme.
Baseline and periodic PSA in the relevant age group, and blood pressure monitoring per the warnings added in the 2025-02-28 class labelling change.
Fertility counselling documented before initiation: exogenous testosterone suppresses spermatogenesis, and men seeking to conceive should be routed to alternatives rather than started on it.
No marketing of testosterone for age-related low testosterone, ageing, vitality or performance. The Limitation of Use for age-related hypogonadism was retained in the 2025-02-28 class labelling change even though the cardiovascular boxed warning was removed.
Approved products
Depo-Testosterone · ANDA 085635 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Testosterone is a component of approved drugs, so the 503A bulks list is irrelevant to it, and approved injectable products are commercially available, so compounded testosterone injections are copies. The binding constraint is not compounding at all — it is the Controlled Substances Act. Testosterone is Schedule III, remote prescribing currently rests on a temporary DEA telemedicine flexibility that expires on 2026-12-31, the special registration contemplated by the Ryan Haight Act was never finalised as a rule, and a patient at home fits none of the seven statutory exceptions in 21 U.S.C. 802(54). Also record the 2025-02-28 class labelling change accurately, because it is routinely misdescribed: the TRAVERSE trial results were added, the Limitation of Use for age-related hypogonadism was RETAINED, the boxed cardiovascular-risk language was REMOVED, and blood pressure warnings were ADDED. Removal of the CV boxed warning is not permission to market testosterone for ageing — the Limitation of Use survived and is the provision that governs that claim.
Authority
ANDA 085635 (Depo-Testosterone); 21 U.S.C. 802(41) and 21 CFR 1308.13(f) (Schedule III anabolic steroid); 21 U.S.C. 829(e) and 802(54) (Ryan Haight in-person requirement and the seven telemedicine exceptions); DEA temporary telemedicine flexibility expiring 2026-12-31; FDA class labelling change for testosterone products, 2025-02-28 (TRAVERSE results added; age-related hypogonadism Limitation of Use retained; boxed CV-risk language removed; blood pressure warnings added)
Also asked for as female testosterone, testosterone for HSDD, AndroFeme, low-dose testosterone cream for women, testosterone for low libido
8 conditions, all required
The operator must acknowledge in writing that no FDA-approved testosterone product exists for women, that all use is therefore off-label or compounded, and that no efficacy or safety finding by FDA supports any dose in women.
Controlled-substance prescribing authority must be established and evidenced for every state of operation, with PDMP checks at initiation and at each fill, exactly as for the men's testosterone rows.
A documented plan for 2026-12-31, when the DEA telemedicine flexibility expires. There is no finalised successor, the special registration contemplated by the Ryan Haight Act was never completed, and a patient at home satisfies none of the seven statutory exceptions. The plan must include orderly wind-down as an option rather than an assumption of extension.
The only use this platform supports is postmenopausal hypoactive sexual desire disorder, diagnosed after a formal biopsychosocial assessment and documented as such — which is the only evidence-based indication the 2019 Global Consensus Position Statement recognises. Testosterone must not be offered to women for energy, mood, ageing, body composition, cognition or 'optimisation'; none of those uses has an approved indication or an evidence base in women.
Dosing must be at female physiological replacement — of the order of a tenth of a male dose — with the calculation recorded, and total testosterone measured at baseline and during treatment with a defined threshold above which therapy is stopped.
Documented counselling on virilising effects, with the ones that do not reverse on withdrawal — voice deepening and clitoral enlargement — named rather than grouped under side effects.
Contraception documented in any woman who could become pregnant, and treatment refused in pregnancy or while breastfeeding.
No compounded testosterone preparation at a strength or route that would make it a copy of an approved male product, and no compounded pellet in any circumstance; see the compounded hormone pellet row, which is refused outright.
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
There is no FDA-approved testosterone product for women in the United States. Every approved testosterone product is indicated in males — Testopel's indications section is headed 'MALES', and Depo-Testosterone's reads 'replacement therapy in the male' — so any use in a woman is off-label use of a male product, or a compounded preparation, and there is no third option. Two products operators cite as precedent are not precedent: Intrinsa, the testosterone patch for surgically menopausal women, went to FDA's Advisory Committee for Reproductive Health Drugs on 2004-12-02 under NDA 21-769 and was never approved; and Estratest, the esterified oestrogens with methyltestosterone that pharmacies still reference, was never an FDA-approved product at all. AndroFeme has no United States marketing authorisation and must never be described as though it had. Testosterone is a Schedule III anabolic steroid whatever the patient's sex, so every controlled-substance constraint in the men's testosterone rows applies here in full, including the DEA telemedicine flexibility expiring on 2026-12-31, and a woman at home satisfies none of the seven statutory telemedicine exceptions. The clinical position that governs this row is the 2019 Global Consensus Position Statement, endorsed by the major endocrine and menopause societies, which holds that the only evidence-based indication in women is postmenopausal hypoactive sexual desire disorder diagnosed after formal biopsychosocial assessment, that off-label use of an approved male formulation is reasonable where concentrations are kept in the physiological female range, that compounded testosterone cannot be recommended unless no authorised equivalent is available, and that any preparation producing supraphysiologic concentrations — pellets and injections are named — is not recommended. The dosing problem is the practical one: a female physiological dose is of the order of a tenth of a male dose, and dividing a product designed for men is where virilisation comes from. Because testosterone is a component of approved drugs the bulk basis exists, but a compounded testosterone cream at a strength close to an approved product is still exposed to the copy test, and in California 16 CCR 1735(d) has no strength or route element at all.
Authority
No FDA-approved testosterone product indicated for women; ANDA 080911 (Testopel, indications section headed 'MALES'; adverse reactions reported in women include hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness and menstrual irregularities; Pregnancy Category X); approved testosterone labelling indicating replacement therapy in the male; NDA 21-769 (Intrinsa, testosterone transdermal system for surgically menopausal women, FDA Advisory Committee for Reproductive Health Drugs 2004-12-02, never approved); 21 U.S.C. 802(41) and 21 CFR 1308.13(f)(84) (testosterone, Schedule III anabolic steroid); 21 U.S.C. 829(e) and 802(54) (Ryan Haight in-person requirement and the seven telemedicine exceptions); DEA telemedicine flexibility expiring 2026-12-31; Davis SR et al., 'Global Consensus Position Statement on the Use of Testosterone Therapy for Women', J Clin Endocrinol Metab 2019;104(10):4660-4666 (published simultaneously in J Sex Med, Maturitas and Climacteric); 21 U.S.C. 353a(b)(2); 16 CCR 1735(d)
Also asked for as Testopel, testosterone pellet implant, hormone pellets
4 conditions, all required
All conditions from the injectable testosterone row apply in full, including controlled-substance authority per state, laboratory-confirmed diagnosis, haematocrit and PSA monitoring, and a documented plan for the 2026-12-31 DEA expiry.
A licensed in-person implantation setting and operator must be contracted and named before the line is enabled; this is a procedural product and cannot be delivered by a shipping model.
Only the FDA-approved pellet product; compounded testosterone pellets are refused as copies of a commercially available drug.
Documented consent recording that the dose cannot be reduced or withdrawn after implantation, and that erythrocytosis or other adverse effects must be managed by phlebotomy or by waiting for the implant to exhaust.
Approved products
Testopel · ANDA 080911 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
An approved testosterone pellet exists, so compounded testosterone pellets are copies of a commercially available product — which is worth stating plainly, because compounded pellets are marketed heavily and at supraphysiologic doses. The structural problem with pellets in a telehealth model is that they require an in-office implantation procedure and cannot be withdrawn once implanted: if the level runs high or an adverse effect emerges, there is no dose reduction available, only time. Schedule III, so the DEA telemedicine constraints and the 2026-12-31 expiry apply.
Authority
ANDA 080911 (Testopel); 21 CFR 1308.13(f) (Schedule III); 21 U.S.C. 353a(b)(2); DEA telemedicine flexibility expiring 2026-12-31
Also asked for as AndroGel, Testim, Fortesta, Vogelxo, testosterone gel, testosterone solution, Axiron
4 conditions, all required
All conditions from the injectable testosterone row apply in full, including controlled-substance authority per state, PDMP checks, laboratory-confirmed diagnosis, haematocrit and PSA monitoring, and a documented plan for the 2026-12-31 DEA expiry.
Secondary-exposure counselling documented at every dispense: the surviving boxed warning on topical testosterone concerns virilisation of children through contact with the application site, not cardiovascular risk.
Household screening at intake for children or a pregnant partner, with covering of the application site, hand washing and washing before skin-to-skin contact stated as instructions rather than tips.
No marketing of testosterone for age-related low testosterone, ageing or vitality; the Limitation of Use for age-related hypogonadism was retained on 2025-02-28.
Approved products
AndroGel · NDA 021015 · approved Feb 28, 2000
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Schedule III, so every constraint in the injectable testosterone row applies here too, including the 2026-12-31 DEA telemedicine expiry. The distinguishing feature is the boxed warning that survives on the topical gels after the 2025-02-28 class change: it concerns SECONDARY EXPOSURE — virilisation of children through skin-to-skin contact with the application site — and not cardiovascular risk. Operators frequently assume the surviving boxed warning is about the heart; it is not, and the counselling and household-safety obligations follow from the actual warning. Approved gels are commercially available, so compounded testosterone creams are copies.
Authority
NDA 021015 (AndroGel, approved 2000-02-28); approved labelling boxed warning on secondary exposure and virilisation in children; 21 CFR 1308.13(f) (Schedule III); FDA class labelling change, 2025-02-28; DEA telemedicine flexibility expiring 2026-12-31
Also asked for as Jatenzo, Tlando, Kyzatrex, oral testosterone, testosterone undecanoate capsules
4 conditions, all required
All conditions from the injectable testosterone row apply in full, including controlled-substance authority per state, PDMP checks, laboratory-confirmed diagnosis, haematocrit and PSA monitoring, and a documented plan for the 2026-12-31 DEA expiry.
Blood pressure measured at baseline and monitored during treatment, consistent with the warnings added in the 2025-02-28 class labelling change; uncontrolled hypertension is an exclusion.
Food-administration counselling documented, since absorption is food-dependent and adherence errors present as treatment failure.
No marketing for age-related low testosterone, ageing or vitality; the Limitation of Use was retained.
Approved products
Jatenzo · NDA 206089 · approval date unverified
Tlando · NDA 208088 · approval date unverified
Kyzatrex · NDA 213953 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Three approved oral testosterone undecanoate products exist, which removes the historical objection that oral testosterone is inherently hepatotoxic — that concern attaches to the 17-alpha-alkylated androgens, not to these. Blood pressure is the specific labelled concern for this route and it is the reason the class received added blood pressure warnings in the 2025-02-28 labelling change. Schedule III, so all DEA telemedicine constraints and the 2026-12-31 expiry apply. Absorption depends on food, which makes counselling a real adherence variable rather than a formality.
Authority
NDA 206089 (Jatenzo); NDA 208088 (Tlando); NDA 213953 (Kyzatrex); 21 CFR 1308.13(f) (Schedule III); FDA class labelling change, 2025-02-28 (blood pressure warnings added); DEA telemedicine flexibility expiring 2026-12-31
Also asked for as zolpidem, Ambien, Ambien CR, Edluar, Intermezzo, zaleplon, Sonata, eszopiclone, Lunesta, z-drugs
5 conditions, all required
Controlled-substance prescribing authority must be established per state, with PDMP checks at each fill and a documented plan for 2026-12-31 when the DEA telemedicine flexibility expires.
Any history of a complex sleep behaviour — sleepwalking, sleep-driving, or performing other activities while not fully awake — after taking a z-drug is an absolute contraindication and must be a hard stop in the intake, not a warning.
Prescribe at the lowest effective dose with sex-specific dosing enforced where the label requires it, and treat duration as limited rather than open-ended; refills must not renew indefinitely without prescriber review.
Screen and exclude concurrent CNS depressants including opioids and alcohol use that the patient cannot moderate, and require a documented next-morning impairment warning covering driving.
Offer ramelteon, low-dose doxepin or a dual orexin receptor antagonist first where clinically appropriate; a z-drug should not be the default first-line product in a consumer sleep programme.
Approved products
Ambien · NDA 019908 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
All three are Schedule IV and all three carry the class boxed warning on complex sleep behaviours — sleepwalking, sleep-driving and engaging in other activities while not fully awake, which have resulted in serious injuries and death. The point most often missed in intake design is that the label makes these drugs contraindicated in patients who have previously experienced a complex sleep behaviour after taking them, so that history is a hard exclusion rather than a caution. Because they are controlled, the 2026-12-31 DEA telemedicine expiry applies to this line as it does to testosterone and ketamine. Application numbers for zaleplon and eszopiclone were not verified for this revision.
Authority
NDA 019908 (Ambien); 21 CFR 1308.14 (Schedule IV); FDA-required class boxed warning on complex sleep behaviours and contraindication in patients who have experienced them (2019 class labelling change); 21 U.S.C. 829(e); DEA telemedicine flexibility expiring 2026-12-31
Next review
Nov 15, 2026
Compoundable · 2
There is a lawful compounding basis for this preparation and no approved product it would be a copy of. Rare, and worth reading the basis rather than assuming it generalises.
Also asked for as LDN, naltrexone 4.5mg, naltrexone 1.5mg, low dose naltrexone, naltrexone
Compounding
503A · permitted503B · copy riskbulk basis · component of an approved drug
Low-dose naltrexone has an unusually strong non-copy position and it is worth understanding precisely, because it is the counter-example that shows the copy test is a real test rather than a blanket bar. The 503A copy analysis asks whether the compounded product has the same active ingredient at the same or a similar strength — within about ten percent, or easily substitutable — by the same route. The approved oral naltrexone strength is 50 mg. LDN is dosed at 1.5 to 4.5 mg, which is between roughly three and nine percent of the approved strength: far outside a ten percent band, and not reachable by splitting a 50 mg tablet into anything a patient could dose reliably. So it is not essentially a copy, and the bulk basis is satisfied because naltrexone is a component of an approved drug — the bulks list is not the operative question. What LDN does not have is an approved indication at this dose for anything, so the clinical claims are the exposure, not the compounding.
Authority
21 U.S.C. 353a(b)(2) (essentially a copy — same active ingredient, same or similar strength, same route); 21 U.S.C. 353a(b)(1)(A)(i) (naltrexone is a component of an approved drug); approved oral naltrexone 50 mg labelling
Also asked for as tri-mix, bimix, quadmix, intracavernosal injection, penile injection, ICI therapy, papaverine phentolamine alprostadil
Compounding
503A · permitted503B · copy riskbulk basis · component of an approved drug
This is the cleanest compounding position on the whole formulary and the one worth understanding properly. There is no FDA-approved multi-drug intracavernosal product, so trimix is not a copy of anything — the copy test needs a commercially available drug product to be a copy of, and none exists for this combination. Alprostadil and phentolamine are both components of FDA-approved drugs, which satisfies the 503A bulk basis for those two. Papaverine is the weak link: it is not FDA-approved in any current product, so it rests on the USP monograph prong of 503A(b)(1)(A)(i) rather than the approved-drug prong. FLAGGED AS UNCERTAIN — obtain written confirmation from the dispensing pharmacy that the papaverine hydrochloride API it uses complies with a current USP monograph and that it holds the certificate of analysis, before any brand goes live. At 503B the analysis is different and less favourable, because 503B requires each bulk substance to appear on the 503B bulks list or be used in a drug on the shortage list.
Authority
21 U.S.C. 353a(b)(1)(A)(i) (USP or NF monograph, or component of an approved drug); 21 U.S.C. 353a(b)(2) (copy test — inapplicable where no commercially available product exists); 21 U.S.C. 353b(a)(2) (503B bulk substance requirements)
Next review
Feb 12, 2027
Approved, prescribed off-label · 5
An FDA-approved product exists and the use we support is outside its labelled indication. Lawful to prescribe, and a prescriber's judgement rather than a marketing claim — the labelled indication is not what is being sold.
Also asked for as Arimidex, anastrozole 1mg, aromatase inhibitor
Approved products
Arimidex · NDA 020541 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for breast cancer in postmenopausal women. Use in men to manage aromatisation on testosterone therapy is off-label and lawful for a prescriber, but it is not an approved use and must not be presented as one. The clinical caution belongs in the platform rather than in a prescriber's discretion: oestradiol is not a waste product in men, and over-suppression causes bone mineral density loss, joint symptoms, dyslipidaemia and loss of libido — the last of which patients then attribute to insufficient testosterone, producing a dose spiral. Reflexive co-prescription with every testosterone start should be blocked; it should follow a measured oestradiol and symptoms.
Authority
NDA 020541 (Arimidex, approved for breast cancer in postmenopausal women); no approved male indication; 21 U.S.C. 352(f) and 331 (promotion of unapproved uses)
Also asked for as Clomid, Serophene, clomiphene citrate, clomid for men
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Clomiphene is approved for ovulatory failure in women. Use in men for secondary hypogonadism or for fertility preservation is off-label, which is lawful for a prescriber but must never be described as approved. Clomiphene is a mixture of the enclomiphene and zuclomiphene isomers, which is the whole argument for enclomiphene as a purer alternative — and clomiphene has the decisive regulatory advantage of being an approved drug with commercially available product, which enclomiphene is not. Application numbers were not verified for this revision.
Authority
FDA-approved clomiphene citrate products for ovulatory failure in women (no approved male indication); 21 U.S.C. 352(f) and 331 (promotion of unapproved uses); 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
Also asked for as Avodart, Jalyn, dutasteride 0.5mg
Approved products
Avodart · NDA 021319 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved in the United States for benign prostatic hyperplasia only. Use for androgenetic alopecia is off-label and lawful for a prescriber, but the brand should not describe dutasteride as approved for hair loss in any marketing asset — it is approved for BPH, and in the United States for nothing else. Dutasteride is a component of an approved drug, so the bulks list is not the question; approved 0.5 mg capsules are commercially available, so compounded dutasteride is a copy. The long elimination half-life, materially longer than finasteride's, is the clinically relevant difference for counselling and for the blood-donation restriction.
Authority
NDA 021319 (Avodart, approved for benign prostatic hyperplasia); 21 U.S.C. 353a(b)(2); off-label prescribing is lawful for a licensed prescriber but promotion of an unapproved use is not (21 U.S.C. 352(f), 331)
Also asked for as Glucophage, Glucophage XR, metformin hydrochloride, metformin ER, metformin for longevity
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for type 2 diabetes. Use for longevity, prediabetes management or weight is off-label and lawful for a prescriber, but it is not an approved indication and must not be marketed as one. Two points to state plainly, because both come up in diligence. First, the NDMA recalls were confined to EXTENDED-RELEASE metformin, they concerned specific manufacturers and lots, and they are a closed historical matter — they are not a reason to avoid metformin, and immediate-release product was never implicated. Second, the boxed warning for lactic acidosis is current and is what actually governs the programme: renal function must be established before initiation and monitored, and the drug must be held around iodinated contrast imaging and in acute illness with dehydration. Approved products are commercially available, so compounded metformin is a copy. Application numbers were not verified for this revision.
Authority
FDA-approved metformin products for type 2 diabetes; approved labelling boxed warning for lactic acidosis; FDA recalls of extended-release metformin for NDMA (2020, specific manufacturers and lots; immediate-release not implicated); 21 U.S.C. 352(f) and 331 (promotion of unapproved uses). Application numbers unverified in this revision.
Also asked for as Desyrel, trazodone hydrochloride, trazodone 50mg for sleep, Oleptro
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Trazodone is approved for major depressive disorder. Its use at low doses for insomnia is off-label — lawful for a prescriber, but it is not an approved insomnia product and must never be described as one in marketing. It is not a controlled substance, which is why it is so widely used in this space, but it does carry the antidepressant class boxed warning for suicidal thoughts and behaviours in patients under 25, and that warning travels with the off-label use. Priapism is a rare but labelled event requiring urgent care, which is a specific counselling obligation for any brand also selling erectile dysfunction products to the same customer. Orthostatic hypotension and next-day sedation are the common problems. Application numbers were not verified for this revision.
Authority
FDA-approved trazodone products for major depressive disorder (no approved insomnia indication); antidepressant class boxed warning; approved labelling (priapism; orthostatic hypotension); 21 U.S.C. 352(f) and 331 (promotion of unapproved uses). Application numbers unverified in this revision.
Next review
Feb 12, 2027
Approved · 47
An FDA-approved product exists for the use we support, and that product is what is dispensed.
Also asked for as Caverject, Caverject Impulse, Muse, prostaglandin E1, PGE1, Edex
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved single-agent alprostadil products exist for intracavernosal injection and as a urethral suppository, so a compounded single-agent alprostadil injection would be a copy. This is precisely why trimix is different — the multi-drug intracavernosal combination has no approved counterpart. Application numbers were not verified against the FDA approval record for this revision, so approvedProducts is empty rather than guessed; verify before publishing this row externally.
Authority
FDA-approved alprostadil products for erectile dysfunction (intracavernosal injection and urethral suppository); 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Component of an approved drug, so the bulk basis is satisfied, but a compounded oral avanafil is a copy of Stendra. Avanafil's faster onset is the usual reason a brand asks for it; it is available as the approved product.
Also asked for as Azelex, Finacea, azelaic acid 15%, azelaic acid 20%, Finacea foam
Approved products
Azelex · NDA 020428 · approval date unverified
Finacea · NDA 207071 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved at 20 percent for acne and at 15 percent for rosacea. Not controlled, no REMS, and unlike most of the pigmentation category it is usable in pregnancy, which makes it the natural substitute wherever hydroquinone or a retinoid is excluded. Compounded azelaic acid at approved strengths is a copy.
Also asked for as Latisse, bimatoprost 0.03%, Lumigan, eyelash serum prescription
Approved products
Latisse · NDA 022369 · approved Dec 24, 2008
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Latisse is the FDA-approved product for hypotrichosis of the eyelashes and it is the only approved drug for that indication. Its existence is what makes compounded lash serums and off-label glaucoma drops unnecessary as well as unlawful to copy. Counsel on the two labelled cosmetic risks that generate complaints: increased brown iris pigmentation, which may be permanent, and periorbital fat atrophy with skin darkening.
Authority
NDA 022369 (Latisse, approved 2008-12-24, for hypotrichosis of the eyelashes); 21 U.S.C. 353a(b)(2)
Also asked for as Wellbutrin, Wellbutrin XL, Wellbutrin SR, Zyban, Aplenzin, Forfivo XL, bupropion hydrochloride
Approved products
Wellbutrin XL · NDA 021515 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not a controlled substance, no REMS, with the antidepressant class boxed warning. Bupropion's contraindications are the reason it needs explicit platform enforcement rather than prescriber discretion, because they are absolute and they are frequently missed in an asynchronous intake: a seizure disorder; a current or prior diagnosis of bulimia or anorexia nervosa, which roughly doubles the seizure risk; abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptic drugs; and use of a monoamine oxidase inhibitor within the preceding 14 days. Each of these must be a hard stop in the intake logic, not a warning the patient can click past. Note also that bupropion is a component of the approved weight-loss combination with naltrexone, which is a separate row.
Authority
NDA 021515 (Wellbutrin XL); approved bupropion labelling, Contraindications (seizure disorder; current or prior bulimia or anorexia nervosa; abrupt discontinuation of alcohol, benzodiazepines, barbiturates or antiepileptic drugs; MAOI within 14 days); antidepressant class boxed warning
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for anxiety, not a controlled substance, no REMS, and no boxed warning — it is not an antidepressant and does not carry the class suicidality warning. That combination makes buspirone the most telehealth-tractable anxiety drug on the formulary and the correct answer to a request for a benzodiazepine in a generalised anxiety presentation. Contraindicated with MAOIs; grapefruit and strong CYP3A4 inhibitors raise exposure. Application numbers were not verified for this revision.
Authority
FDA-approved buspirone products for anxiety disorders; approved labelling (no boxed warning; MAOI contraindication). Application numbers unverified in this revision.
Also asked for as Cleocin T, clindamycin phosphate topical, clindamycin 1%, clindamycin benzoyl peroxide
Approved products
Cleocin T · NDA 050600 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS. The labelled caution about pseudomembranous colitis following topical clindamycin is rare but is in the label and belongs in the counselling copy. Antimicrobial stewardship rather than regulation is the reason to pair it with benzoyl peroxide rather than dispense it as monotherapy; approved fixed combinations exist.
Conjugated oestrogens are a defined mixture obtained from pregnant mares' urine, not a single synthesised molecule, and no compounder can reproduce the mixture. There is nothing to compound here and any offer of 'compounded Premarin' should be treated as a supplier problem. The commercially important change on this row is recent: the first ANDA conjugated oestrogens tablets were approved on 2025-10-15, which FDA described on 2025-11-10 as the first such approval in more than thirty years, so a generic now exists where none did. The boxed warning has NOT been converted on Premarin: the labelling published in June 2026 still carried endometrial cancer, cardiovascular disorders, breast cancer and probable dementia, and so did the generic. Cenestin and Enjuvia are on FDA's converted list of 2026-02-12 while Drugs@FDA records them as discontinued — approved labelling and commercial availability are separate facts and an operator must not read the one as the other.
Authority
NDA 004782 (Premarin, conjugated estrogens tablets); NDA 020216 (Premarin Vaginal Cream, approved 1978-10-16); ANDA 214023 and ANDA 214025 (first generic conjugated estrogens tablets, approved 2025-10-15); FDA news release of 2025-11-10 recording approval of the first generic of Premarin in more than thirty years; FDA drug alert of 2025-11-10 retaining the endometrial-cancer boxed warning for systemic oestrogen-alone products; 21 U.S.C. 353a(b)(1)(A)
Bazedoxifene replaces the progestogen: it opposes the oestrogen at the endometrium so that a woman with a uterus does not need a separate progestin. That is the clinical point of the product and it is the reason the labelling says in terms that a woman taking it must not take additional oestrogens. There is nothing to compound — conjugated oestrogens cannot be reproduced by a compounder and bazedoxifene is not available on any compounding basis. This row is also the clearest evidence that the 2026 boxed-warning conversion is incomplete: the labelling published on 2026-08-03 still carried a boxed warning for endometrial cancer, cardiovascular disorders and probable dementia. It omits breast cancer, which no other oestrogen-containing product on this formulary does, so do not copy warning text between rows.
Authority
NDA 022247 (Duavee, conjugated estrogens and bazedoxifene, approved 2013-10-03); approved labelling boxed warning on endometrial cancer, cardiovascular disorders and probable dementia, and the instruction that women taking Duavee should not take additional oestrogens; FDA drug alert of 2025-11-10 and FDA news release of 2026-02-12 (conversion not yet reaching this product)
Also asked for as Silenor, doxepin 3mg, doxepin 6mg, low dose doxepin
Approved products
Silenor · NDA 022036 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The other non-controlled, no-boxed-warning insomnia option, approved for sleep maintenance. Two distinctions matter. First, the low-dose product is a different regulatory article from the antidepressant-dose doxepin capsules, which do carry the antidepressant class boxed warning — do not merge them in a catalogue or a claim. Second, because approved 3 mg and 6 mg tablets exist, compounding a low-dose doxepin is a copy rather than a workaround. Contraindicated in untreated narrow-angle glaucoma and in severe urinary retention, and contraindicated with MAOIs.
Authority
NDA 022036 (Silenor, doxepin 3 mg and 6 mg, for insomnia characterised by difficulty with sleep maintenance); not scheduled under 21 CFR 1308; approved labelling carries no boxed warning
Also asked for as Cymbalta, Drizalma Sprinkle, duloxetine delayed-release
Approved products
Cymbalta · NDA 021427 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS, with the antidepressant class boxed warning. Hepatotoxicity warnings make substantial alcohol use and chronic liver disease exclusions rather than cautions. Its approved indications extend to several chronic pain conditions, which is a legitimate adjacent line but a different clinical programme with different follow-up.
Authority
NDA 021427 (Cymbalta); antidepressant class boxed warning; approved labelling warnings on hepatotoxicity
Approved on 2025-10-24 as a dual neurokinin 1 and neurokinin 3 receptor antagonist for moderate to severe vasomotor symptoms; this is the second non-hormonal approval FDA referred to in its announcement of 2025-11-10. Its labelling carries no boxed warning, which distinguishes it from fezolinetant and is the fact most likely to be misused in copy. It is not warning-free: the labelling addresses central nervous system depressant effects and next-day impairment, hepatic transaminase elevations, risk of pregnancy loss and risk of seizures, is contraindicated in pregnancy, and provides for hepatic testing at baseline and follow-up. The honest comparison is a lighter hepatic monitoring burden than fezolinetant, not the absence of one, and it is a new molecular entity whose postmarketing record is a year old.
Authority
NDA 219469 (Lynkuet, elinzanetant, approved 2025-10-24); approved labelling (no boxed warning; contraindicated in pregnancy; warnings on CNS depressant effects and next-day impairment, hepatic transaminase elevations, pregnancy loss and seizures); FDA news release of 2025-11-10 recording approval of a non-hormonal treatment for moderate to severe vasomotor symptoms
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS. Carries the antidepressant class boxed warning. Dose-dependent QT prolongation is a labelled concern for the citalopram family; escitalopram's ceiling is lower than citalopram's but an ECG-relevant cardiac history should still route to synchronous review rather than an asynchronous refill.
Authority
NDA 021323 (Lexapro); antidepressant class boxed warning; FDA drug safety communications on QT prolongation in the citalopram family
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved systemic oestradiol exists in patch, gel, spray and oral form, so compounded systemic oestradiol is a copy of a commercially available drug and is refused on the compounded row rather than here. Oral oestradiol tablets are approved and dispensed generically; the brand Estrace tablet applications (ANDA 084499 and ANDA 084500, 1975) are discontinued, which is a commercial fact rather than a safety one. The fact that governs marketing on this row is that the class boxed warning is being dismantled PRODUCT BY PRODUCT and is not yet gone. FDA requested the change on 2025-11-10 and approved the first six products on 2026-02-12; 29 companies had submitted proposed labelling at that point. Divigel is converted and its boxed warning now reads endometrial cancer with unopposed oestrogen in women with a uterus, and nothing else. Climara, EstroGel, Minivelle, Vivelle-Dot and Evamist were still carrying the full four-part warning — endometrial cancer, cardiovascular disorders, probable dementia and breast cancer — on the labels published to DailyMed through mid-2026. Evamist carries a fifth element the others do not: unintentional secondary exposure to oestrogen. An operator must therefore read the labelling of the product it actually dispenses and must not describe the boxed warning as removed across the class.
Authority
NDA 020375 (Climara, approved 1994-12-22); NDA 020538 (Vivelle-Dot, approved 1996-07-31); NDA 203752 (Minivelle, approved 2012-10-29); NDA 021166 (EstroGel, approved 2004-02-09); NDA 022038 (Divigel, approved 2007-06-04); NDA 022014 (Evamist, approved 2007-07-27); FDA drug alert 'FDA Requests Labeling Changes ... for Menopausal Hormone Therapies', 2025-11-10 (boxed-warning language on cardiovascular disease, breast cancer and probable dementia removed; endometrial-cancer boxed warning retained for systemic oestrogen-alone products); FDA news release 'FDA Approves Labeling Changes to Menopausal Hormone Therapy Products', 2026-02-12 (first six products only); 21 U.S.C. 353a(b)(2)
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved local vaginal oestradiol exists as a cream, as an insert and as a ring, which is why the compounded version is refused on its own row. Two things on this row are routinely got wrong. First, Femring is not a local product: it is estradiol acetate at systemic doses and is indicated for vasomotor symptoms, so it should be treated as systemic therapy and it needs endometrial protection in a woman with a uterus. Second, the boxed-warning position is not uniform even inside this group. Estring was one of the six products FDA converted on 2026-02-12 and its current labelling carries no boxed warning at all, while Vagifem, Imvexxy and Estrace Cream were still carrying the full four-part warning on the labels published to DailyMed. Copy for a vaginal line must be written against the specific product dispensed. Estrace Cream is an ANDA rather than an NDA because oestradiol is a pre-1962 substance; that is a filing-route fact and not a quality one.
Authority
ANDA 086069 (Estrace Cream, approved 1984-01-31); NDA 020908 (Vagifem, approved 1999-03-26); NDA 208564 (Imvexxy, approved 2018-05-29); NDA 020472 (Estring, approved 1996-04-26); NDA 021367 (Femring, estradiol acetate, approved 2003-03-20); FDA drug alert of 2025-11-10 (for local vaginal oestrogen products FDA requested condensed safety information prioritising what is relevant to the local formulation); FDA 'Menopausal Hormone Therapies with Updated Prescribing Information', content current 2026-02-12, listing Estring as the topical vaginal oestrogen converted; 21 U.S.C. 353a(b)(2)
Also asked for as Bijuva, Activella, Amabelz, CombiPatch, Climara Pro, Angeliq, Prempro, Premphase, combined HRT, combined MHT, estrogen plus progestin
Approved products
Bijuva (estradiol and progesterone capsules) · NDA 210132 · approved Oct 28, 2018
Activella (estradiol and norethindrone acetate tablets) · NDA 020907 · approved Nov 18, 1998
CombiPatch (estradiol and norethindrone acetate transdermal system) · NDA 020870 · approved Aug 7, 1998
Climara Pro (estradiol and levonorgestrel transdermal system) · NDA 021258 · approved Nov 21, 2003
Prempro / Premphase (conjugated estrogens and medroxyprogesterone acetate tablets) · NDA 020527 · approved Nov 17, 1995
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Bijuva is the entry that matters commercially, because it is an FDA-APPROVED combination of oestradiol and micronized progesterone — the exact pairing that compounded 'bioidentical' programmes were built to supply. Its existence removes the last respectable argument for a compounded oestradiol-plus-progesterone capsule, which is now a copy of a commercially available drug. Bijuva was converted on 2026-02-12 and carries no boxed warning; Activella, CombiPatch, Climara Pro, Angeliq and Prempro were all still carrying the full four-part warning on the labels published through mid-2026, so the same programme can be selling one product with a boxed warning and one without. Climara Pro's progestogen is levonorgestrel, not norethindrone, and it is described wrongly often enough to be worth stating.
Authority
NDA 210132 (Bijuva, estradiol and progesterone capsules, approved 2018-10-28); NDA 020907 (Activella); NDA 020870 (CombiPatch); NDA 021258 (Climara Pro, estradiol and levonorgestrel); NDA 021355 (Angeliq, drospirenone and estradiol); NDA 020527 (Prempro and Premphase, approved 1995-11-17); FDA 'Menopausal Hormone Therapies with Updated Prescribing Information', content current 2026-02-12, listing Bijuva as the systemic oestrogen-and-progestogen product converted; 21 U.S.C. 353a(b)(2)
A neurokinin 3 receptor antagonist for moderate to severe vasomotor symptoms, and the non-hormonal option for a woman who cannot or will not take oestrogen. It is approved, so it belongs on this formulary — but it is the one row here where the approval is not the hard part. FDA added a BOXED WARNING for hepatotoxicity on 2024-12-16 after postmarketing liver injury, having added a non-boxed warning on 2024-09-12. The labelling requires hepatic laboratory tests before the first dose, monthly for the first three months, and again at six and nine months, and it says not to start if either aminotransferase or total bilirubin is at or above twice the upper limit of normal. A telehealth model that cannot actually obtain and act on serial laboratory results should not sell this drug, because the monitoring is the label rather than a recommendation.
Authority
NDA 216578 (Veozah, fezolinetant, approved 2023-05-12); FDA Drug Safety Communication of 2024-09-12 and its update of 2024-12-16 adding a boxed warning for hepatotoxicity; approved labelling 'WARNING: RISKS OF HEPATOTOXICITY' with hepatic testing before initiation, monthly for three months, and at six and nine months; approved labelling contraindications (known cirrhosis, severe renal impairment or end-stage renal disease, concomitant CYP1A2 inhibitors)
Also asked for as Propecia, Proscar, finasteride 1mg, finasteride 5mg, generic Propecia
Approved products
Propecia · NDA 020788 · approved Dec 19, 1997
Proscar · NDA 020180 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Finasteride is a component of approved drugs, so the 503A bulks list is not the operative question for it in any route — a point worth making to pharmacies that cite the bulks list as though it were the only test. Approved 1 mg and 5 mg oral products exist, so any compounded oral finasteride is a copy. Proscar's approval date was not verified for this revision and is recorded as null.
Also asked for as Prozac, Sarafem, fluoxetine hydrochloride
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not a controlled substance, no REMS. The antidepressant class boxed warning for suicidal thoughts and behaviours in children, adolescents and young adults applies and must appear in patient-facing materials, not only in the pharmacy leaflet. Fluoxetine's long half-life makes it the most forgiving SSRI for missed doses and the least likely to produce discontinuation syndrome, which is a genuine operational advantage for asynchronous care. Application numbers were not verified for this revision.
Authority
FDA-approved fluoxetine products; antidepressant class boxed warning (suicidal thoughts and behaviours in patients under 25) under 21 CFR 201.57(c)(1); 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
Also asked for as Vistaril, Atarax, hydroxyzine pamoate, hydroxyzine hydrochloride
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for anxiety and tension and for pruritus, not a controlled substance, no REMS, no boxed warning. This is the non-scheduled as-needed anxiolytic — the answer to an intermittent-anxiety request that would otherwise pull toward a benzodiazepine, with no dependence liability and no DEA exposure. QT prolongation is a labelled concern, so avoid stacking it with other QT-prolonging agents, and anticholinergic burden makes it a poor choice in older patients. Application numbers were not verified for this revision.
Authority
FDA-approved hydroxyzine products for anxiety and pruritus; approved labelling (QT prolongation; no boxed warning). Application numbers unverified in this revision.
Also asked for as Nizoral, ketoconazole shampoo, ketoconazole 2%, ketoconazole 1%, anti-dandruff ketoconazole
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Two distinct regulatory articles share the name. Ketoconazole 2 percent shampoo is a prescription product approved for tinea versicolor and seborrhoeic dermatitis; ketoconazole 1 percent shampoo is available over the counter. Neither is approved for androgenetic alopecia, so any hair-loss positioning is off-label and must not appear in marketing as an approved use. This is the low-risk adjunct in a hair stack: topical, no systemic exposure of consequence, no REMS, no controlled-substance status. Application numbers were not verified for this revision and approvedProducts is left empty rather than guessed.
Authority
FDA-approved ketoconazole 2% shampoo (prescription, seborrhoeic dermatitis and tinea versicolor) and 1% shampoo (OTC); 21 U.S.C. 352(f) and 331 (promotion of unapproved uses). Application numbers unverified in this revision.
Approved products exist for chronic weight management and for type 2 diabetes, and generic liraglutide has entered the market. Liraglutide was named alongside semaglutide and tirzepatide in FDA's 2026-05-01 proposal not to include these substances on the 503B bulks list, so the compounded route is closing here as well. Daily rather than weekly dosing makes adherence the practical constraint. Application numbers were not verified for this revision.
Authority
FDA-approved liraglutide products for chronic weight management and for type 2 diabetes; GLP-1 class boxed warning; FDA proposed determination not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, 2026-05-01. Application numbers unverified in this revision.
Also asked for as MetroGel, MetroCream, Noritate, metronidazole 0.75%, metronidazole 1% gel, rosacea gel
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved topical products exist for inflammatory lesions and erythema of rosacea. Not controlled, no REMS, negligible systemic exposure. Application numbers were not verified against the FDA approval record for this revision, so approvedProducts is empty rather than guessed.
Authority
FDA-approved topical metronidazole products for rosacea; 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Oral micronized progesterone is approved and is generically available, so a compounded oral progesterone capsule is a copy. This row carries the endometrial-protection duty for the whole category: a woman with an intact uterus taking systemic oestrogen needs a progestogen, and the approved oral route is the one with evidence behind it. Progesterone was the progestogen-alone product FDA converted on 2026-02-12 — the labelling published to DailyMed in July 2026 carries no boxed warning, where the 2024 labelling had carried cardiovascular disorders, breast cancer and probable dementia for oestrogen plus progestin therapy. Two operational facts that cost money if missed: the approved capsules are formulated in peanut oil, so a peanut allergy is a genuine exclusion rather than a formality, and the labelled dosing is at bedtime because sedation is the expected effect rather than an adverse one.
Authority
NDA 019781 (Prometrium, micronized progesterone capsules, approved 1998-05-14); approved labelling (peanut oil excipient; bedtime administration); FDA 'Menopausal Hormone Therapies with Updated Prescribing Information', content current 2026-02-12, listing Prometrium as the progestogen-alone product converted; 21 U.S.C. 353a(b)(2)
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Topical minoxidil is over the counter by approved application — NDA and ANDA — not by OTC monograph. The distinction is load-bearing and gets it wrong constantly: a monograph drug can be manufactured by anyone conforming to the monograph, whereas an NDA-approved OTC drug cannot. It means a private-label topical minoxidil must be made under an approved application or an ANDA referencing one, and it means a compounded topical minoxidil at an approved strength is a copy of a commercially available drug. Compounded strengths above 5 percent are the usual ask; they have no approved counterpart at that strength but also no controlled evidence, and they raise the systemic absorption question that the oral minoxidil row addresses.
Authority
NDA 021812 (Rogaine 5% Foam, approved 2006-01-20); 21 U.S.C. 355 (OTC by approved application, not by monograph under 21 U.S.C. 355h); 21 U.S.C. 353a(b)(2)
Also asked for as Remeron, Remeron SolTab, mirtazapine orally disintegrating
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for major depressive disorder, not controlled, no REMS, with the antidepressant class boxed warning. Sedation and appetite and weight increase are the dominant effects at low doses; that makes it useful where insomnia and low appetite accompany depression, and unsuitable where a patient is simultaneously enrolled in a weight programme. Agranulocytosis is a rare labelled event that should be a stop-and-call instruction on fever or sore throat. Application numbers were not verified for this revision.
Authority
FDA-approved mirtazapine products for major depressive disorder; antidepressant class boxed warning; approved labelling (agranulocytosis). Application numbers unverified in this revision.
Also asked for as doxycycline, doxycycline hyclate, doxycycline monohydrate, Oracea, minocycline, Solodyn, subantimicrobial dose doxycycline
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Multiple approved oral doxycycline and minocycline products exist, including modified-release and subantimicrobial-dose formulations for acne and rosacea, so compounded oral tetracyclines are copies. Application numbers were not verified for this revision and approvedProducts is left empty rather than guessed. Operationally, these are the highest-friction drugs in an otherwise clean dermatology catalogue: photosensitivity with sun-exposure counselling, contraindication in pregnancy and in children under eight, oesophageal irritation requiring upright administration with water, and for minocycline specifically the drug-induced lupus, hyperpigmentation, vestibular and DRESS signals that make it the second-line choice of the pair. Duration limits and a stewardship policy should be enforced by the platform rather than left to the prescriber.
Authority
FDA-approved oral doxycycline and minocycline products for acne and rosacea; 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
Also asked for as Foundayo, oral GLP-1 non-peptide, orforglipron tablets
Approved products
Foundayo · NDA 220934 · approved Apr 1, 2026
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The first oral non-peptide GLP-1 receptor agonist. Two things distinguish it commercially. It is not a peptide, so it is not subject to the peptide sourcing and stability problems that make the compounded GLP-1 market what it is; and because it is a small molecule that is a component of an approved drug, the 503A bulk basis question is answerable — which means the copy test, rather than the absence of a basis, is what would bar a compounded version. It is not a controlled substance. Confirm the boxed warning and contraindication set against the current approved labelling before writing patient-facing copy; the class thyroid C-cell warning should be assumed to apply until verified.
Authority
NDA 220934 (Foundayo, orforglipron, approved 2026-04-01, oral); not scheduled under 21 CFR 1308; 21 U.S.C. 353a(b)(2)
Also asked for as Xenical, Alli, orlistat 120mg, orlistat 60mg
Approved products
Xenical · NDA 020766 · approval date unverified
Alli · NDA 021887 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Both a prescription strength and an over-the-counter strength are approved by application. Not controlled, no REMS, no boxed warning, and no laboratory requirement — the lowest-friction weight product on the formulary and the natural fallback where a GLP-1 is unaffordable or contraindicated. Efficacy is modest and gastrointestinal tolerability drives discontinuation. Counsel on fat-soluble vitamin supplementation and on the interaction with levothyroxine and ciclosporin, and note the rare hepatic injury signal in the labelling.
Authority
NDA 020766 (Xenical, prescription); NDA 021887 (Alli, OTC); not scheduled under 21 CFR 1308; approved labelling carries no boxed warning
An oral non-oestrogen for moderate to severe dyspareunia due to menopause, and the answer for a patient who will not use a vaginal product. It is an oestrogen agonist/antagonist with agonist effects at the endometrium, which is why its boxed warning is what it is. Ospemifene is not on FDA's 2026-02-12 converted list and its labelling published in February 2025 still carried a boxed warning for endometrial cancer and cardiovascular disorders. That is consistent with the conversion being aimed at oestrogen and progestogen products rather than at selective oestrogen receptor modulators, but it is an inference from the roster rather than a statement FDA has made, so treat it as unsettled and re-read the label at review.
Authority
NDA 203505 (Osphena, ospemifene, approved 2013-02-26); approved labelling boxed warning 'ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS'; FDA 'Menopausal Hormone Therapies with Updated Prescribing Information', content current 2026-02-12 (ospemifene not listed)
Also asked for as Paxil, Pexeva, paroxetine hydrochloride, paroxetine mesylate
Approved products
Paxil · NDA 020031 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS, with the antidepressant class boxed warning. Paroxetine is the SSRI most often used off-label for premature ejaculation, and that off-label use is lawful for a prescriber — but the two operational costs are real: it has the strongest discontinuation syndrome in the class because of its short half-life and lack of an active metabolite, so a lapsed refill produces symptoms, and it is a potent CYP2D6 inhibitor, which matters for anyone on tamoxifen or on other CYP2D6 substrates.
Authority
NDA 020031 (Paxil); antidepressant class boxed warning; 21 U.S.C. 352(f) and 331 (promotion of unapproved uses)
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The only SSRI with an approved indication for moderate to severe vasomotor symptoms associated with menopause, at a dose well below any psychiatric dose, and its labelling states in terms that it is not indicated for any psychiatric condition. Two things follow and both are commonly got wrong. It carries the SSRI class boxed warning on suicidal thoughts and behaviours — that is the boxed warning on this product, and it has nothing to do with the oestrogen class warning, so a brand that describes this as a way to avoid a boxed warning is wrong. And paroxetine is a strong CYP2D6 inhibitor, which makes it the wrong choice for a woman taking tamoxifen, a population that overlaps heavily with the women seeking non-hormonal treatment. See the separate paroxetine row in mental health for the psychiatric product; they are different articles at different doses.
Authority
NDA 204516 (Brisdelle, paroxetine mesylate 7.5 mg, approved 2013-06-28); approved labelling boxed warning 'SUICIDAL THOUGHTS AND BEHAVIORS' and Limitations of Use (not indicated for any psychiatric condition); paroxetine CYP2D6 inhibition and the tamoxifen interaction in approved labelling
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The approved vaginal DHEA product, indicated for moderate to severe dyspareunia due to menopause. It is worth carrying on a menopause formulary for two reasons. It has never had a boxed warning and did not need one removed, which makes it the cleanest label in the category — its only warning of substance concerns current or past breast cancer. And its existence makes DHEA a component of an FDA-approved drug, which is exactly why FDA's 503B nomination list marks dehydroepiandrosterone as such: a compounded vaginal DHEA preparation is therefore a copy of a commercially available product rather than a novel offering. Oral DHEA sold as a supplement is a different article again and is not a substitute for this one.
Authority
NDA 208470 (Intrarosa, prasterone vaginal insert, approved 2016-11-16); approved labelling (no boxed warning; warning on current or past history of breast cancer); FDA 'Bulk Drug Substances Nominated for Use in Compounding Under Section 503B', updated 2025-03-21, marking dehydroepiandrosterone as a component of an FDA-approved drug; 21 U.S.C. 353a(b)(2)
Also asked for as Tri-Luma, hydroquinone 4%, Kligman formula, triple cream, melasma cream, hydroquinone tretinoin fluocinolone
Approved products
Tri-Luma · NDA 021112 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Tri-Luma is the only FDA-approved hydroquinone product in the United States, and its composition is the Kligman formula — hydroquinone with a retinoid and a corticosteroid. That single fact decides the entire compounded-pigmentation question. Custom triple creams are marketed as bespoke, but they are the Kligman formula by another name: same active ingredients, same topical route, strengths within or easily substitutable for the approved product. They are squarely copies under 503A(b)(2), and in California under 16 CCR 1735(d) the presumption is stronger still because no strength or route element applies there. Where a genuine clinical difference exists — a documented allergy to an excipient in the approved product, for instance — the four-prescriptions-per-prescriber-per-calendar-month ceiling applies, with each refill counted separately, which is not a scale channel.
Authority
NDA 021112 (Tri-Luma — the only FDA-approved hydroquinone product); 21 U.S.C. 353a(b)(2) and 353a(b)(1)(D); 16 CCR 1735(d) and 1736(e)
Also asked for as Rozerem, melatonin receptor agonist
Approved products
Rozerem · NDA 021782 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Ramelteon and low-dose doxepin are the two prescription insomnia products that are not controlled substances and carry no boxed warning. For a telehealth platform that is a structural advantage, not a clinical footnote: no DEA exposure, no PDMP obligation, no exposure to the 2026-12-31 telemedicine cliff, and no complex-sleep-behaviour contraindication to police. Contraindicated with fluvoxamine, a strong CYP1A2 inhibitor, and not for use with severe hepatic impairment.
Authority
NDA 021782 (Rozerem, melatonin receptor agonist for insomnia characterised by difficulty with sleep onset); not scheduled under 21 CFR 1308; approved labelling carries no boxed warning
This row is the approved injectable product dispensed through ordinary licensed channels. Compounding it is a separate row and is refused: the shortage was resolved on 2025-02-21, enforcement discretion ended in 2025, semaglutide is not on the 503B bulks list, and FDA proposed on 2026-05-01 not to add it. Note the class boxed warning for thyroid C-cell tumours, with medullary thyroid carcinoma and MEN 2 as contraindications. Application numbers for the injectable products were not verified for this revision and are recorded as empty rather than guessed.
Authority
FDA-approved semaglutide injection products for chronic weight management and for type 2 diabetes; GLP-1 class boxed warning for thyroid C-cell tumours; 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
This is the oral obesity approval, and it should not be confused with the oral semaglutide approved for type 2 diabetes, which is a separate row and a separate application. Its existence removes the last commercial argument for compounded oral semaglutide, which was never viable anyway: oral semaglutide bioavailability is around one percent and depends on the absorption enhancer salcaprozate sodium, which a compounder cannot replicate. Carries the GLP-1 class boxed warning for thyroid C-cell tumours.
This application is approved for type 2 diabetes only. Do not conflate it with the oral Wegovy tablet approved on 2025-12-22 for chronic weight management under a different application — they are different products with different indications, and marketing that treats them as interchangeable is promotion of an unapproved use. Rybelsus is being discontinued and replaced by Ozempic tablets; that is a brand transition, not a shortage, and it does not create any compounding basis. Carries the GLP-1 class boxed warning for thyroid C-cell tumours.
Authority
NDA 213051 (oral semaglutide, indicated for type 2 diabetes mellitus only); GLP-1 class boxed warning; 21 U.S.C. 352(f) and 331 (promotion of unapproved uses); 21 U.S.C. 353a(b)(2)
Also asked for as Zoloft, sertraline hydrochloride
Approved products
Zoloft · NDA 019839 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS. Carries the antidepressant class boxed warning. Sertraline is also used off-label for premature ejaculation, either daily or on demand; that use is lawful for a prescriber but is not an approved indication and must not be described as approved in marketing.
Authority
NDA 019839 (Zoloft); antidepressant class boxed warning; 21 U.S.C. 352(f) and 331 (promotion of unapproved uses)
Also asked for as Viagra, sildenafil citrate, Revatio, generic Viagra
Approved products
Viagra · NDA 020895 · approved Mar 27, 1998
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
A 503A basis exists — sildenafil citrate is a component of an approved drug, so the bulks list is not the operative question. The obstacle is the copy test. A compounded oral sildenafil product is the same active ingredient, at a strength that is within ten percent or easily substitutable, by the same oral route, so it is essentially a copy of Viagra and its generics. Route governs the 503A analysis rather than dosage form, which is why calling it a troche, chew or hard mint does not change the answer.
Authority
NDA 020895 (Viagra, approved 1998-03-27); 21 U.S.C. 353a(b)(2) (essentially a copy of a commercially available drug product)
Also asked for as Vybrique, sildenafil film, sildenafil oral soluble film, dissolvable sildenafil
Approved products
Vybrique · NDA 210858 · approved Dec 16, 2025
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
This row matters commercially out of proportion to its size. The standard defence for compounded sildenafil chews and troches was that some patients cannot or will not swallow a tablet, which was offered as a clinical difference justifying compounding. Vybrique is an FDA-approved sildenafil oral film, marketed from 2026-02-15, so that justification is gone: there is now a commercially available, swallow-free, approved sildenafil product. Any compounded dissolvable sildenafil is now a copy of an approved article in the same format.
Also asked for as Cialis, Adcirca, generic Cialis, tadalafil daily
Approved products
Cialis · NDA 021368 · approved Nov 21, 2003
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Same analysis as sildenafil. Tadalafil is a component of an approved drug so the bulk basis exists, but any compounded oral form is essentially a copy. Approved tadalafil covers both on-demand and daily dosing, which removes the last plausible clinical argument for a compounded strength.
Also asked for as Tazorac, Arazlo, Fabior, tazarotene lotion, tazarotene cream
Approved products
Tazorac · NDA 020600 · approval date unverified
Arazlo · NDA 211882 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved for acne and psoriasis depending on the product and strength. Not controlled, no REMS. Tazarotene is the retinoid with the clearest teratogenicity signal of the topical group and the intake must treat pregnancy as an exclusion rather than a counselling point.
The approved injectable products are the only lawful route. The shortage was resolved on 2024-12-19, enforcement discretion ended in 2025, tirzepatide is not on the 503B bulks list, and FDA proposed on 2026-05-01 not to include it. Carries the class boxed warning for thyroid C-cell tumours, with medullary thyroid carcinoma and MEN 2 as contraindications. Application numbers were not verified for this revision.
Authority
FDA-approved tirzepatide products for chronic weight management and for type 2 diabetes; GLP-1 class boxed warning; FDA resolution of the tirzepatide shortage, 2024-12-19; 21 U.S.C. 353a(b)(2). Application numbers unverified in this revision.
Also asked for as Retin-A, Retin-A Micro, Altreno, Renova, Atralin, topical retinoid, tretinoin cream, tretinoin gel
Approved products
Retin-A · NDA 017340 · approval date unverified
Altreno · NDA 209353 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Dermatology is the cleanest category on this formulary and tretinoin is the cleanest row in it: approved, not controlled, no REMS, no laboratory requirement, multiple approved strengths and vehicles including a lotion. Because approved products span the strength range brands ask for, a compounded tretinoin is a copy rather than a necessity. The one genuine compounding question is the multi-agent 'custom' cream, which is addressed in the prescription hydroquinone row. Pregnancy exclusion should be enforced in the intake even though systemic absorption from topical tretinoin is low.
Also asked for as Levitra, Staxyn, vardenafil hydrochloride
Approved products
Levitra · NDA 021400 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
The Levitra brand has been discontinued in the US, but AB-rated generics are marketed. Discontinuation of a brand does not make a drug not commercially available for copy-test purposes while therapeutically equivalent generics remain on the market, so compounded vardenafil is still a copy. Vardenafil has a longer QT signal than the other PDE5 inhibitors and should not be used with class IA or class III antiarrhythmics. The approval date for NDA 021400 was not verified for this revision and is recorded as null rather than guessed.
Also asked for as Effexor XR, venlafaxine extended release, venlafaxine hydrochloride ER
Approved products
Effexor XR · NDA 020699 · approval date unverified
Compounding
503A · copy risk503B · copy riskbulk basis · component of an approved drug
Approved, not controlled, no REMS, with the antidepressant class boxed warning. Two constraints belong in the platform rather than in a prescriber's memory: dose-dependent blood pressure elevation, which requires a blood pressure value at intake and at escalation, and a severe discontinuation syndrome on missed doses, which makes refill continuity a clinical control rather than a retention metric.
Authority
NDA 020699 (Effexor XR); antidepressant class boxed warning; approved labelling warnings on dose-related increases in blood pressure
Next review
Feb 12, 2027
How to read this page
Two dates sit in the eyebrow above, and they mean different things. The version is the revision of the compiled list, moved when the list is re-derived from primary sources. The timestamp is when a row in the table last changed, read from the row itself — so an unchanged version with a recent timestamp means an individual position moved, not the whole list. Both come out of the database on request; neither is written into this page.
Every entry carries a review date, and the authorities behind several of them expire — enforcement discretion can be withdrawn by a single Federal Register notice, and a telemedicine flexibility has a date on it. Every dated entry is inside its review window, the next falling due Oct 15, 2026.
A refusal here is not advisory. A brand cannot enable a refused substance in the platform: the write is rejected by the database, with the reason above and its citation attached to the error. A conditional substance is enabled only once every one of its conditions has been accepted individually — accepting most of them is rejected in the same way, which is how a controlled-substance line stops going live because nobody read the fourth bullet.
What this page is not: legal advice, and not a substitute for a brand’s own counsel or its dispensing pharmacies. State law is frequently stricter than the federal position recorded here — California’s compounding copy test is the clearest example, and it has no strength or route element at all. Where a row is uncertain, the row says so in its own words rather than being rounded to a clean answer.
The same data is machine-readable at /api/v1/formulary, one substance at a time at /api/v1/formulary/{slug} — which resolves aliases, so Viagra reaches the sildenafil row — and documented at the API reference. Reliability is measured and published on the status page, including objectives currently being missed, and the security posture is measured from the database catalogue on the security page. Each of the three is built to be read by someone who has not signed anything.
