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Peptides Explained

Acts on the brain

Semax

Registered as nose drops in Russia, not in the EU. Its effects and safety are little studied.

Not an authorised medicine

Short page. This is a short page. A full page with the complete evidence review is planned for version 1.1. The grades and regulatory status below are complete and sourced.

At a glance

Is it an approved medicine?
No Not approved as a medicine in the EU, the UK or the US.
Has it been tested in people?
Some Small trials in patients. No large trials published yet.
Is it allowed in sport?
Unclear Not named on the anti-doping list. Ask your anti-doping organisation before using it in sport. Regulatory status
What is the biggest risk?
Little safety data. Products may hold germs or the wrong drug. More about the risks

Status checked on . The details and sources are further down this page.

Stop and get help if you notice

  • Swollen face or throat, or trouble breathing50,2
  • Bleeding or bruising for no clear reason2
  • Eye pain or burning after nose drops2

If it is severe, call your local emergency number.

All warning signs, further down this page Warning signs for any peptide

The 30-second version

About 5 minutes for the short version; 11 with every detail open.

  • Semax is a lab-made chain of seven amino acids. It is a medicine in Russia.
  • It is not approved in the EU, the UK or the US.
  • In rats it raised a growth factor for nerve cells. Studies in people are small, mostly in Russian.
  • Its safety in people is barely studied. In mice it boosted the effect of amphetamine.
  • In July 2026, US advisers backed letting pharmacies make it. It was only advice; the law is unchanged.
Class
Acts on the brain
Made of
Seven amino acids: a piece of ACTH plus Pro-Gly-Pro
Registered in
Russia, as nose drops
Developed at
Institute of Molecular Genetics, Moscow
Studies in people
Small, mostly in Russian, nose drops only
Status in the EU
Not authorised
Tested in people
Some

Label facts, not dosing advice. Sources are in the sections below.

Last reviewed
Microscope image of a rat brain slice in blue, green and gold. Curved gold bands of tightly packed cell nuclei trace the layers of the hippocampus.
The hippocampus of a rat. In rats, Semax raised a growth factor for nerve cells in this area. Photo: NIH Image Gallery from Bethesda, Maryland, USA, National Institutes of Health (Wikimedia Commons) CC BY 2.0 Image details

Each section starts with the short answer. The rest is folded under “In detail”.

Evidence profile

Four separate questions. Not a score.

Human clinical evidence How far has it been tested in people?
Phase II (dose and early effect)
Preclinical volume How much laboratory and animal research exists?
Extensive
Source independence How many independent groups produced it?
A few groups
Safety characterisation How well do we know the harms in humans?
Uncharacterised
In detail Why these grades: the reason for each step
Human clinical evidence
Phase 2 on our rubric. Semax is registered as a medicine in Russia, which the rubric would normally grade as 'authorised'. We do not, because the trials behind that registration are not published in a form outside reviewers can check: the FDA could not evaluate the Russian-language stroke studies. The published human evidence is small controlled studies in patients, such as 110 people after a stroke, without clear randomisation or blinding.
Preclinical volume
Extensive. On 22 October 2026 PubMed held 197 records on Semax that are not reviews or comments, most of them animal and cell studies.
Source independence
Few groups. About 115 of those 197 records list authors from the developers at the Institute of Molecular Genetics and Moscow State University, and most of the rest come from other Moscow institutes. Studies from outside Russia are few, mostly on how Semax binds copper, from Italy.
Safety characterisation
Uncharacterised. The FDA found no human pharmacokinetic studies and no safety data for injection. Studies in about 550 to 570 people, 451 of them children, mostly did not report side effects. No standard toxicity studies in animals were found.

We never add these up. A compound can have a large animal literature from one laboratory and no human data at all — that is a specific situation, and a single number would hide it. How we grade evidence

In detail The molecule: amino-acid sequence and technical details
Amino-acid sequence7 amino acids

H–Met-Glu-His-Phe-Pro-Gly-Pro–OH

Read from the N-terminus (start) to the C-terminus (end).

Full name
ACTH(4–7)-Pro-Gly-Pro
Also called
MEHFPGP, ACTH(4-10) analogue
Class
Acts on the brain
Body systems
Brain and nerves
Formula
C37H51N9O10S
Molecular mass
813.9 Da

What it actually is

What is Semax?

A lab-made chain of seven amino acids. It is a medicine in Russia.
Semax is a Russian medicine. It is not approved in the EU, the UK or the US. What is known about the substance sold under this name, checked on 22 October 2026.
Semax
Made in a lab?Yes Seven amino acids: a piece of the hormone ACTH plus Pro-Gly-Pro.1,2
A registered medicine anywhere?Yes In Russia, as nose drops.2,3
Approved in the EU, the UK or the US?No EMA lists no product, and it is not FDA-approved.4,2
Well tested for safety?No The FDA found too little data to describe its safety.2

In the US, Semax is sold as nose sprays and injections by clinics and online shops, for memory, anxiety, stroke and more.2 A Russian registration says nothing about products sold elsewhere under the name.

In detail The molecule, and what a Russian registration means

Semax is Met-Glu-His-Phe-Pro-Gly-Pro, formula C37H51N9O10S, mass 813.9 g/mol.1 Its first four amino acids match part of ACTH, a pituitary hormone. The ending Pro-Gly-Pro is thought to protect it from enzymes. It lacks ACTH’s hormone effects.2 It was made at the Institute of Molecular Genetics of the Russian Academy of Sciences.3

A registration in Russia lets the product be sold there. It is not an assessment by any EU, UK or US regulator. It does not make Semax legal to supply as a medicine in the Netherlands.5

Proposed mechanism

How does it work?

Not well understood. In rats it raised a growth factor for nerve cells.
The proposed causal chain, step by step

Each step is labelled with how well the link from the previous step is established.

  1. Step 1 Binding In cells

    Binds sites in rat brain tissue; the receptor is unknown

    Labelled Semax bound specifically to membranes from rat brain, but the receptor itself has not been identified. The FDA calls its mechanisms poorly understood.

  2. Step 2 Cell response In animals

    More BDNF, a growth factor for nerve cells

    One dose in the nose raised BDNF protein in the rat hippocampus, a brain area for memory, up to 1.4-fold. Shown by the developers' group.

  3. Step 3 Tissue response In animals

    Less brain damage after an experimental stroke in rats

    In rats, the damaged brain area was about 20% smaller with Semax. Rats also showed less blood clotting, which may help in a stroke but raises a bleeding question.

  4. Step 4 Effect on the body Hypothesised

    Better recovery in people: not shown

    Small Russian studies in stroke patients report faster recovery, but they were not clearly randomised or blinded, and the FDA found the evidence insufficient.

In detail What each step rests on

Labelled Semax bound to rat brain membranes, and one dose in the nose raised BDNF in the rat brain. Both findings come from the developers’ institute.6,7 The FDA summarises the rat stroke work and the clotting effects. It notes that most studies used a single dose and that the mechanisms are poorly understood.2

What the evidence actually shows

Does it work?

Unknown. Animal studies are many. Studies in people are small and hard to check.

The largest stroke study was small and not clearly randomised

110

people after a stroke, with or without Semax

Who took part Gusev 2018: rehabilitation patients in Moscow, Russian-language paper; allocation and blinding not stated Source Gusev et al. (2018)8 Evidence Humans, limited

In a migraine study, most headaches did not stop

4 of 12

people with migraine whose headache stopped after one dose; the other 8 said the pain eased

Who took part Koroleva 1996: one dose in the nose, no comparison group (FDA review) Sources FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026; Koroleva et al. (1996)2,9 Evidence Humans, limited

The FDA concluded that there is not enough evidence that Semax works for stroke, migraine or facial nerve pain.2

In detail Every study in one table

6 studies: 3 in humans, 2 in animals, 0 in cells, 1 reviews or other.

Studies discussed on this page
Study Species n Design Funding Research group What it found What it did not show
Koroleva et al. 1996 9 Humans 37 Case series (uncontrolled) Not disclosed Mixed One dose in the nose in 12 people with migraine and 25 with facial nerve pain: headache stopped in 4 of the 12 and eased in the other 8; in typical trigeminal neuralgia nothing changed; in 9 people with dental nerve pain, pain stopped in 6 and eased in 3. No control group, no blinding and unclear rating scales (FDA review); a single dose.
Gusev et al. 1997 10 Humans 110 Open-label study (controlled) Not disclosed Mixed 30 people in the first days after a stroke got Semax with standard care. Compared with 80 similar people on standard care, the authors report somewhat faster recovery of movement and other functions. Russian-language; how patients were allocated is not described; no blinding reported; a developer of Semax was an author.
Eremin et al. 2004 24 Mixed not reported Animal experiment (controlled) Not disclosed Independent group Given before amphetamine, Semax raised the peak of dopamine in the rat brain. Given with amphetamine, it made mice more active than amphetamine alone (261% against 182% of normal activity). Rats and mice; one laboratory; Russian-language with an English abstract; says nothing directly about abuse in people.
Dolotov et al. 2006 7 Rats not reported Animal experiment (controlled) Not disclosed Originating group One dose given into the nose raised BDNF protein in the rat hippocampus up to 1.4-fold, with more activity of its receptor, and rats learned an avoidance task better. Rats; the developers' institute; animal numbers not stated in the abstract.
Gusev et al. 2018 8 Humans 110 Open-label study (controlled) Not disclosed Independent group In 110 people in rehabilitation after a stroke, with or without Semax, blood BDNF rose with Semax, and scores for daily living improved faster. Russian-language; allocation and blinding not stated in the abstract; the FDA did not evaluate it because no English text was available.
Vanhee et al. 2020 25 — not reported Product testing Government Independent group Two unknown products seized in Belgium in 2017 and 2018 turned out to contain Selank and Semax; both peptides were freely sold online as powder for injection or as nasal sprays. Two products; shows what is on the illegal market, not what typical products contain.

Most stroke studies are in Russian. The FDA did not evaluate them, because no English text was available.2,10,8 Most research comes from Moscow institutes linked to the developers.11

Regulatory status

Is it legal?

Not approved in the EU, the UK or the US. Its status in sport is unclear.
It is not an approved medicine here. The July 2026 US vote did not change that. Status in the Netherlands, the EU and the US, and in sport, checked on 22 October 2026.
Netherlands and the EUUnited States
Approved as a medicine?No No EU or Dutch authorisation.12,13No Not FDA-approved.2
Legal to sell or supply as a medicine?No Dutch law forbids supplying a medicine without a marketing authorisation, with narrow exceptions.5No Not until the FDA makes a rule adding it to the 503A list.14
Allowed in sport?Unknown Not named on the list. It is registered in Russia, so the catch-all ban (S0) may not apply. Ask your anti-doping organisation.15,16,2Unknown The same worldwide rule.17
In detail Status in each country, and in sport
Regulatory status by jurisdiction
Jurisdiction Status Note Checked
European Union Not authorised No authorised product, and no record in EMA's medicines data (checked 22 October 2026). 4,12
Netherlands Not authorised Not authorised; supplying an unauthorised medicine is prohibited by the Geneesmiddelenwet. 13,5
United States Not authorised Not FDA-approved. The July 2026 advisory vote to recommend pharmacy compounding is non-binding; no rule has been made. 2,22,19,18
Sport (WADA) Unclear (not named) Not named on the List. Because it is registered in Russia, it is unclear whether S0 applies: ask your anti-doping organisation. 15,17,16,2

All statuses were checked on 22 October 2026. The CBG database lists no Semax product.13 The FDA had put Semax in category 2, for substances that may present significant safety risks; the nominations were later withdrawn.18

In sport, S0 bans substances that no government health authority has approved. Semax is registered in Russia, so S0 may not cover it. WADA warns that peptides that are not named may still be banned under another section.15,16 The sport row in the table is not a ruling. Only an anti-doping organisation can give one.

In detail The July 2026 US vote, point by point
  • On 23 July 2026 the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted 8–6 with one abstention to recommend BPC-157 for the 503A bulk drug substances list (count as reported from the public meeting).19,20
  • The committee considered seven peptides, including Semax, which the FDA reviewed for poor blood flow to the brain, migraine and facial nerve pain.19,21 As reported from the meeting, it recommended six: BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon; emideltide (DSIP) was not recommended. The FDA asked for separate votes on the free base and the acetate salt of each.20 The FDA had posted no minutes by 23 October 2026, so the counts and outcome above are as reported from the public meeting.
  • The vote is advisory and non-binding, and it went against FDA staff’s own recommendation not to list Semax.22
  • Legal compounding remains prohibited until the FDA formally adopts the recommendation and completes rulemaking.14
  • None of these is an approved medicine in the EU, the UK or the US. Semax is registered as a medicine in Russia, as the FDA’s own briefing notes. A 503A listing would allow pharmacy compounding on prescription in the US. It is not a marketing authorisation, says nothing about efficacy, and changes nothing in the EU or the Netherlands.2,23,5

Risk profile

What are the risks?

Little tested in people. In animals it thinned the blood and boosted a stimulant.
Several harms are possible. None has been studied properly in people. What the FDA review and the animal studies suggest, as of 22 October 2026.
Possible harmShown in people?
Bleeding, especially with blood thinnersUnknown In rats, Semax made blood clot less.2
Stronger effects of stimulants such as amphetamineUnknown Seen in rats and mice.24
An immune reaction to the peptide or its impuritiesUnknown The FDA cannot rule it out, by injection or nose spray.2
Eye pain and burningUnknown One person reported it to the FDA after nose drops bought online. Nobody knows if Semax caused it.2
A product that is not what the label saysUnknown Two unidentified seized products turned out to hold Semax.25
In detail What the FDA found, and why it matters

The FDA’s adverse-event database held one report up to December 2025. A woman had eye pain and burning after Semax nose drops bought online. She went to hospital, and the pain had not gone a year later. That does not prove Semax was the cause.2 The published studies in people used nose drops only and mostly did not report side effects. There are no safety data for injections.2

Two animal findings matter for people who combine substances. In rats, Semax made blood clot less, so the FDA raises the risk of bleeding with blood thinners.2 In rats and mice it raised the dopamine response to amphetamine. The FDA calls this “concerning”, because drugs of abuse raise dopamine in the same brain area.24,2

If someone is going to do this anyway

This section exists to reduce harm. It gives no doses, schedules or sourcing advice, and it is not a recommendation to use this compound.

How can someone lower the risk?

Check the product first, bring a doctor in, and know when to stop.

If your product did not come from a pharmacy: check before you use it

These checks can show that something is wrong. None of them can show that a product is good or free of germs.26,27,28

Tick each box when you have checked it.

  • The seal and the vial are whole

    A broken cap or seal, or a cracked vial, can let germs in. Then do not use it.29,30,31

  • The label shows the name, amount, batch number and expiry date

    In the EU, a medicine must show all four, even on a small vial. If one is missing, or the date has passed, that is a warning sign. Take a photo of the label.32,29

  • For Semax

    Check which form the label names. Semax is sold as a free base or an acetate salt. The FDA treats them as different substances.2

  • It looks right

    A liquid, or a powder after mixing, should be clear and colourless, with no bits. Is it cloudy, has it changed colour, or do you see bits? Then do not use it.33,34

  • A lab report proves little if:

    • its batch number is not the one on your vial;
    • it does not name the lab, or has no date or signature;
    • it shows only purity (HPLC), with no test of what it is, such as mass spectrometry;
    • it has no test for germs (sterility) or for toxins from germs (endotoxin).

    Even a full report covers only one sample. A report from the seller comes from someone who gains if it looks good. It cannot show that your vial is clean.35,36,37,38,39

    What a certificate of analysis shows, and what it does not

  • It was kept as the label says

    Heat, freezing and sunlight can damage a peptide. Did it arrive warm, or was it frozen? Then do not use it. Often nobody can tell you how it was kept on the way. If you cannot know, you cannot rule out damage. When in doubt, throw it out.34,40,41,31

    When to throw a vial away

  • Clean steps, and a new sterile needle and syringe every time

    Wash your hands and wipe the rubber top with alcohol. Never share a needle, a syringe or a vial.31,42,40

    Sterile technique, step by step

  • Keep the vial, its label and any papers

    Keep them, even when the vial is empty, until you know you feel well. If you need a doctor, bring them. A lab can test what was inside.43,44

    If something goes wrong

  • Tell a doctor, and agree which checks fit you

    A doctor can help you choose blood tests that fit what you use. In the Netherlands, your doctor must keep what you say private.45,46,47

    Which checks matter, and whyTalking to your doctor

  • Know the warning signs before you start

    Spreading redness, fever, a swollen face or hard breathing need help fast. If it is severe, call your local emergency number.48,49,50

    All warning signs, and how fast to act

When to stop and get help

Sources 50, 48, 2

Stop-now warning signs

Call your local emergency number now

  • Confusion or slurred speech, very fast breathing, or pale, blue or blotchy skin, often with fever or shivering These can be signs of sepsis: the body's reaction to an infection has started to damage its own organs.
  • Fainting and not waking up within a minute, or fainting with chest pain, a racing heart or a fit This can be a dangerous heart rhythm or a severe allergic reaction.
  • Pain at the injection spot that is much worse than it looks, or dark, purple or grey patches or blisters there This can be a rare, fast-spreading infection of the deep layers under the skin (necrotising fasciitis).
  • Swelling of the lips, tongue or throat, trouble breathing or swallowing, wheezing, a hoarse voice, or feeling faint, soon after an injection This can be a severe allergic reaction (anaphylaxis), which is life-threatening and gets worse very quickly.

Get medical help today

  • Fever, shivering or feeling very ill in the days after an injection Germs from the needle, the skin or the product may have reached your blood. If you also have a fast heartbeat or fast breathing, call your local emergency number.
  • Redness, heat, swelling or pain around the injection spot that keeps growing or getting worse This can be a skin infection (cellulitis), which needs antibiotics before it spreads.
  • Red lines that run from the injection spot towards the armpit or groin The infection may be spreading along the lymph vessels, and from there into the blood. If you also have a fever with a fast heartbeat or fast breathing, call your local emergency number.
  • A painful, warm lump that fills with pus This is probably an abscess: it often needs draining by a doctor, so do not squeeze it.
  • You were pricked by a needle that someone else had used Blood on a used needle can pass on HIV and hepatitis B or C, and preventive treatment works best within hours.

Stop and contact a doctor

  • You fainted, but woke up quickly and now feel well Fainting is often harmless, but a doctor should check the cause.
  • A new mole, or a mole that changes size, shape or colour, itches or bleeds A changing mole can be skin cancer, and tanning peptides such as melanotan II have been linked to new and changing moles in case reports.
  • A lump at an injection spot that does not go away, or keeps growing A doctor should check whether it is an abscess, a reaction to the product or something else.
  • An itchy, raised rash, or puffy eyes or lips, while breathing stays normal Your body may be reacting to the product, and using it again can bring the reaction back.
In detail Interactions, checks, and who should not use it

These interactions are plausible from the animal studies; none has been tested in people. A doctor can help you weigh them (see talking to your doctor):

  • Blood thinners and antiplatelet medicines, because Semax made rat blood clot less.2
  • Stimulants, including ADHD medicines and amphetamine, because Semax strengthened amphetamine’s effect on dopamine in rats and mice.24

People with a bleeding disorder or who are pregnant have most reason for caution: there are no data in pregnancy.2 If you compete, ask your anti-doping organisation first. See product risk and sterile technique.

Sources

Every claim on this page links to one of these sources. Scholarly sources link to their DOI; regulatory sources to the regulator's own page.

In detail All 50 sources, numbered as in the text
  1. National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 9811102, Semax. PubChem. Dataset pubchem.ncbi.nlm.nih.gov — accessed 22 October 2026 ↩
  2. U.S. Food and Drug Administration (2026). FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 22 October 2026 ↩
  3. Deigin VI, Poluektova EA, Beniashvili AG, Kozin SA, Poluektov YM (2022). Development of Peptide Biopharmaceuticals in Russia. Pharmaceutics 14:716. Review doi:10.3390/pharmaceutics14040716 ↩
  4. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu — accessed 20 October 2026 ↩
  5. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl — accessed 20 October 2026 ↩
  6. Dolotov OV, Karpenko EA, Seredenina TS, Inozemtseva LS, Levitskaya NG, Zolotarev YA, Kamensky AA, Grivennikov IA, Engele J, Myasoedov NF (2006). Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain. Journal of Neurochemistry 97 Suppl 1:82-86. Research article doi:10.1111/j.1471-4159.2006.03658.x ↩
  7. Dolotov OV, Karpenko EA, Inozemtseva LS, Seredenina TS, Levitskaya NG, Rozyczka J, Dubynina EV, Novosadova EV, Andreeva LA, Alfeeva LY, Kamensky AA, Grivennikov IA, Myasoedov NF, Engele J (2006). Semax, an analog of ACTH(4-10) with cognitive effects, regulates BDNF and trkB expression in the rat hippocampus. Brain Research 1117:54-60. Research article doi:10.1016/j.brainres.2006.07.108 ↩
  8. Gusev EI, Martynov MY, Kostenko EV, Petrova LV, Bobyreva SN (2018). The efficacy of semax in the treatment of patients at different stages of ischemic stroke. Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova 118:61-68. Research article doi:10.17116/jnevro20181183261-68 ↩
  9. Koroleva MV, Meĭzerov EE, Nezavibat'ko VN, Kamenskiĭ AA, Dubynin VA, Iakovlev IuB (1996). Study of the analgesic effect of the semax preparation. Biulleten' Eksperimental'noi Biologii i Meditsiny 122:527-529. Research article PMID 8998343 ↩
  10. Gusev EI, Skvortsova VI, Miasoedov NF, Nezavibat'ko VN, Zhuravleva EIu, Vanichkin AV (1997). Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study). Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova 97:26-34. Research article PMID 11517472 ↩
  11. National Library of Medicine (2026). PubMed searches for Semax and Selank, 22 October 2026 (record counts by authorship and affiliation). PubMed. Dataset pubmed.ncbi.nlm.nih.gov — accessed 22 October 2026 ↩
  12. European Medicines Agency (2026). Medicines data download (JSON report of all EPARs: authorised, refused, withdrawn and suspended medicines). Dataset ema.europa.eu — accessed 20 October 2026 ↩
  13. College ter Beoordeling van Geneesmiddelen (CBG-MEB) (2026). Geneesmiddeleninformatiebank (database of medicines authorised in the Netherlands). Regulator geneesmiddeleninformatiebank.nl — accessed 20 October 2026 ↩
  14. U.S. Food and Drug Administration (2026). Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Regulator fda.gov — accessed 20 October 2026 ↩
  15. World Anti-Doping Agency (2025). World Anti-Doping Code International Standard: Prohibited List 2026. Regulator wada-ama.org — accessed 20 October 2026 ↩
  16. World Anti-Doping Agency (2026). Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List. Regulator wada-ama.org — accessed 22 October 2026 ↩
  17. World Anti-Doping Agency (2026). World Anti-Doping Code International Standard: Prohibited List 2027 (in effect 1 January 2027). Regulator wada-ama.org — accessed 20 October 2026 ↩
  18. U.S. Food and Drug Administration (2026). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Regulator fda.gov — accessed 20 October 2026 ↩
  19. U.S. Food and Drug Administration (2026). July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Regulator fda.gov — accessed 20 October 2026 ↩
  20. U.S. Food and Drug Administration (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  21. U.S. Food and Drug Administration (2026). Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List (FR Doc. 2026-07361). Federal Register. Regulator federalregister.gov — accessed 20 October 2026 ↩
  22. U.S. Food and Drug Administration (2026). FDA Briefing Document Introduction, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  23. U.S. Food and Drug Administration (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov — accessed 20 October 2026 ↩
  24. Eremin KO, Saransaari P, Oja S, Raevskiĭ KS (2004). Semax potentiates effects of D-amphetamine on the level of extracellular dopamine in the Sprague-Dawley rat striatum and on the locomotor activity of C57BL/6 mice. Eksperimental'naia i Klinicheskaia Farmakologiia 67:8-11. Research article PMID 15188751 ↩
  25. Vanhee C, Francotte A, Janvier S, Deconinck E (2020). The occurrence of putative cognitive enhancing research peptides in seized pharmaceutical preparations: An incentive for controlling agencies to prepare for future encounters of the kind. Drug Testing and Analysis 12:371-381. Research article doi:10.1002/dta.2717 ↩
  26. Inspectie Gezondheidszorg en Jeugd (IGJ) (2026). Online medicijnen. Regulator igj.nl — accessed 22 October 2026 ↩
  27. Ashraf AR, Mackey TK, Vida RG, Kulcsár G, Schmidt J, Balázs O, Domián BM, Li J, Csákó I, Fittler A (2024). Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study. Journal of Medical Internet Research 26:e65440. Research article doi:10.2196/65440 ↩
  28. Smith RM, Schaefer MK, Kainer MA, Wise M, Finks J, et al. (2013). Fungal infections associated with contaminated methylprednisolone injections. The New England Journal of Medicine 369:1598-1609. Research article doi:10.1056/NEJMoa1213978 ↩
  29. U.S. Food and Drug Administration (2020). BeSafeRx: Considering an Online Pharmacy?. Regulator fda.gov — accessed 22 October 2026 ↩
  30. Hospira, Inc. / DailyMed (National Library of Medicine) (2026). Sterile Water for Injection, USP: prescribing information. Official product information dailymed.nlm.nih.gov — accessed 20 October 2026 ↩
  31. World Health Organization (2010). WHO best practices for injections and related procedures toolkit (WHO/EHT/10.02). World Health Organization, Geneva. Report who.int — accessed 20 October 2026 ↩
  32. European Parliament and Council of the European Union (2001). Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text). Official Journal of the European Communities, L 311. Law eur-lex.europa.eu — accessed 20 October 2026 ↩
  33. U.S. Food and Drug Administration / DailyMed (National Library of Medicine) (2026). EGRIFTA SV (tesamorelin for injection): prescribing information and instructions for use. Official product information dailymed.nlm.nih.gov — accessed 20 October 2026 ↩
  34. European Medicines Agency (2026). Wegovy (semaglutide): EPAR — overview and product information. Official product information ema.europa.eu — accessed 20 October 2026 ↩
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