Does the FDA vote change anything in Europe?

Two systems: one door in the US, none in Europe

Readers in German-speaking Europe keep asking the same question in different words: the FDA’s committee recommended six peptides in July — so can I get them here now? The answer turns on a structural difference. In the United States, a single federal mechanism decides whether an unapproved substance may be compounded: nomination to the 503A bulks list, a public hearing before the Pharmacy Compounding Advisory Committee, and a rule issued by the FDA. In the European Union there is no such door. The European Medicines Agency has no compounding committee and keeps no list of substances a pharmacy may use. EU law (Directive 2001/83/EC) requires a marketing authorisation for any medicinal product placed on the market, and carves out only two narrow exemptions in Article 3: the magistral formula, a medicine prepared in a pharmacy for an individual patient on a prescription, and the officinal formula, prepared in a pharmacy to a recognised pharmacopoeia for direct supply to that pharmacy’s own patients. Everything about how those exemptions work — who may prepare what, from which raw materials, under what supervision — is national law. The Court of Justice has held that the exemptions must be read strictly, as exceptions to a rule that exists to protect public health (Abcur, 2015). An American advisory vote does not enter this system at any point.

What Europe has actually authorised

None of the seven substances reviewed in July — BPC-157, KPV, TB-500, MOTS-c, Emideltide (DSIP), Semax, Epitalon — and none of the five due in early 2027 — LL-37, Dihexa acetate, injectable GHK-Cu, PEG-MGF, Melanotan II — holds a marketing authorisation in the EU, in Switzerland or in the United Kingdom, has been assessed by the EMA, or has a European Pharmacopoeia monograph. Melanotan II is the one with a history: the Austrian regulator warned in 2009 that it was an unauthorised medicine already circulating on the black market, Germany’s BfArM issued a press warning on 28 October 2010, and nothing has changed since — it remains unauthorised and remains on sale online. (Its cousin Melanotan I, afamelanotide, is authorised, as Scenesse, for a rare light-sensitivity disorder — a different product for a different purpose.) Retatrutide has no application on file with the EMA; Lilly states it is approved by no regulator, plans to file with the FDA first in early 2027, and a European authorisation would follow later. Tirzepatide is the exception that proves the rule: authorised across the EU as Mounjaro on 15 September 2022 for type 2 diabetes, with chronic weight management added in 2023 on a variation Lilly filed that March, and available by prescription in prefilled pens. There is no separate Zepbound brand in Europe.

Germany

Classification. The Arzneimittelgesetz defines a medicine two ways: by presentation (Präsentationsarzneimittel) and by function (Funktionsarzneimittel), the latter covering any substance that acts pharmacologically to modify physiological functions (§ 2 AMG). An injectable peptide is a medicine by function whatever the label says. The words “for research use only” do not move a vial out of the AMG; what matters is what the substance does and how it is sold.

Compounding. A German pharmacy may prepare a medicine for an individual patient on a prescription (Rezeptur, § 1a ApBetrO) — but only from starting materials (Ausgangsstoffe) whose pharmaceutical quality it has verified. § 11 ApBetrO requires an identity test in the pharmacy on every batch; a test certificate (Prüfzertifikat) from a manufacturer licensed under § 13 AMG may replace a full analysis, and without one the pharmacy must analyse the material itself against a recognised method. For BPC-157 and its peers there is no pharmacopoeia monograph to test against, no validated method, and no licensed manufacturer supplying pharmaceutical-grade material for human use. A pharmacist could in principle attempt a documented benefit–risk assessment of an uncertified raw material; in practice that is not achievable for these substances, and the pharmacist bears personal liability under § 5 AMG, which prohibits dispensing a medicine that is “bedenklich” — one where current scientific knowledge gives reasonable grounds to suspect harm out of proportion to any benefit. No peptide appears on the profession’s published list of such preparations; the assessment is the pharmacist’s own, and the risk is the pharmacist’s own. A multi-peptide blend such as GLOW or KLOW compounds every one of these problems.

Import. § 73 AMG prohibits bringing a medicine into Germany unless it is authorised here. Ordering an unauthorised peptide from a third country for personal use is an administrative offence (Ordnungswidrigkeit) under § 97 AMG, and the goods are liable to be seized and destroyed. The customs offence of Bannbruch (§ 372 AO) is formally engaged too, but steps back where the AMG already sanctions the conduct, so a private buyer is dealt with under the AMG. Two nuances. First, the same section allows medicines authorised in Germany to be mail-ordered from a pharmacy elsewhere in the EU or EEA — which is why Mounjaro from a licensed EU online pharmacy is lawful and BPC-157 from anywhere is not. Second, parcels moving between EU member states are not routinely inspected at a border; the customs union removes the checkpoint, not the prohibition.

Anti-doping law. Germany adds a layer most countries lack. The Anti-Doping-Gesetz makes it a criminal offence to acquire, possess or bring into the country a listed doping agent in a “not-small quantity” (nicht geringe Menge), with thresholds fixed by the Dopingmittel-Mengen-Verordnung and no exemption for personal use. The annex to § 2 AntiDopG lists Thymosin-beta-4 and its derivatives — that is, TB-500 — and also Mechano Growth Factor and its variants, which reaches PEG-MGF in the FDA’s second batch. BPC-157, KPV, MOTS-c, Semax, Epitalon, DSIP and GHK-Cu are not listed. So in Germany two substances the FDA committee treated side by side sit in different legal categories: BPC-157 is an unauthorised medicine, TB-500 is an unauthorised medicine and a listed doping agent.

Austria

Austria’s Arzneimittelgesetz mirrors the EU definition, and its regulator has said in terms what German law implies. The Bundesamt für Sicherheit im Gesundheitswesen (BASG) classifies the peptides sold online as medicinal products without authorisation, with the consequence that placing them on the Austrian market and importing them into Austria are both prohibited; it describes the “research chemical” label as a mere protective assertion by the sellers (reine Schutzbehauptung) where the context of the website makes human use obvious; and it notes that buyers, not only sellers and importers, can face legal consequences. Preparation of medicines is reserved to pharmacies (magistrale Zubereitung on an individual prescription); a physician may not manufacture preparations in the practice (Eigenherstellung). Import is governed by a dedicated statute, the Arzneiwareneinfuhrgesetz (AWEG), which — unusually within the EU — also regulates bringing medicines in from other EEA states; violations are administrative offences.

Switzerland

Switzerland is outside the EU and outside Directive 2001/83/EC, but its Heilmittelgesetz reaches the same result by a different route. Article 9 HMG requires Swissmedic authorisation before a medicine is placed on the market and exempts pharmacy preparations (Formula magistralis, Formula officinalis); the implementing ordinance (Art. 37 VAM) limits those preparations to active substances that meet closed criteria, in effect a positive list. The Federal Administrative Court upheld that closed approach in 2018 (C-5702/2015), reasoning that the legislature had deliberately authorised strict quality criteria to prevent the authorisation requirement being sidestepped under the name of extemporaneous preparation. None of the FDA-agenda peptides is on the list.

Enforcement is current. On 22 June 2026 Swissmedic, the Federal Office for Customs and Border Security and Swiss Sport Integrity ran a joint operation, “Peptide 2026”, targeting postal shipments suspected of containing illegally imported peptides: 46 were examined, 23 retained — 21 as doping agents, two as medicinal products — and about 80% came from Poland, often wrongly declared. Swissmedic stated that labels such as “Research Chemical”, “not for human use” or “food supplement” change nothing where products are promoted for human use, and that distributing unauthorised medicines to Swiss customers, including by drop-shipping, is illegal. Two details from the same release are worth reading precisely. The other 23 shipments had to be released because the quantities fell within the legal tolerance for personal import of medicines — Switzerland, unlike Germany, tolerates small personal quantities of medicines authorised elsewhere; that tolerance does not extend to doping agents, for which there is none. And the parcels were caught at all because Switzerland sits outside the EU customs union: a Polish parcel to Zurich crosses a border, a Polish parcel to Munich does not.

Where that leaves the lawful routes

For the seven July peptides, the five second-batch peptides and every blend built from them, there is no lawful route to a patient in Germany, Austria or Switzerland today: no authorised product, no practicable compounding, no permitted import. The two routes that exist are the ones that always existed. Approved medicines, on prescription, for the conditions they are approved for — in the GLP-1 space that means Mounjaro. And clinical trials, which are the only lawful way any European patient will encounter retatrutide before an EMA decision that is not expected before 2028. A recommendation from an American advisory committee changes none of this; a final American rule would not either.

Primary sources (checked 9–10 Sep 2026): Directive 2001/83/EC, Art. 3 (EUR-Lex) · CJEU, Abcur AB v Apoteket, joined cases C-544/13 and C-545/13 (16 July 2015) · CJEU, Novartis v Apozyt, C-535/11 (11 April 2013) · EMA, Mounjaro EPAR (authorised 15 Sept 2022; weight-management variation submitted 8 March 2023) · Eli Lilly, “What to know about retatrutide” (July 2026) · Arzneimittelgesetz (AMG) §§ 2, 5, 13, 73, 96, 97 and Apothekenbetriebsordnung (ApBetrO) §§ 1a, 6, 11, 14, 17 (gesetze-im-internet.de) · Anti-Doping-Gesetz (AntiDopG), Anlage zu § 2 Abs. 3, and Dopingmittel-Mengen-Verordnung (DmMV) of 10 March 2023 · AkdÄ, “Bedenkliche Rezepturarzneimittel” (2018) · BfArM press release of 28 Oct 2010 on melanotan · BASG, “Peptide – illegale Präparate aus dem Internet” (Amtliche Nachrichten, 2026) and AGES PharmMed warning on Melanotan II (May 2009) · Swiss Heilmittelgesetz (HMG) Art. 9 and Arzneimittelverordnung (VAM) Art. 37 (Fedlex) · Swiss Federal Administrative Court, C-5702/2015 (29 March 2018) · Swissmedic / BAZG / Swiss Sport Integrity, “Schwerpunktaktion Peptide 2026” (22 June 2026, published 30 June 2026). The German analysis on this page is built from the statutory text; no published German court decision or regulator statement applying these provisions specifically to research-grade peptides has been identified, and the application to them is therefore our reading rather than settled practice. Where a German legal concept has no exact English equivalent, the German term is given in parentheses.