O mercado de peptídeos de pesquisa nos Estados Unidos e no Brasil, medido

01Principais conclusões

Três pontos chamam atenção. Primeiro, os dois mercados estão divergindo no produto: os análogos de GLP-1 praticamente desapareceram das lojas americanas de peptídeos de pesquisa depois das cartas de advertência do FDA entre 2024 e 2026, enquanto no Brasil eles são o centro de um mercado informal que analistas estimam em cerca de metade de todo o gasto com GLP-1. Segundo, a prática de certificação, e não o preço, é a verdadeira linha divisória entre fornecedores: quase todos declaram uma pureza, poucos publicam um documento vinculado ao lote emitido por laboratório identificado, e testes revisados por pares já encontraram frascos com uma fração da pureza declarada. Terceiro, os reguladores estão se movendo em ordens opostas. O FDA cortou primeiro a tirzepatida manipulada e depois a semaglutida; a ANVISA proibiu a semaglutida manipulada e manteve aberta a manipulação de tirzepatida, sob regras mais rígidas.

02Panorama do mercado dos Estados Unidos

O canal americano de peptídeos de pesquisa vende peptídeos liofilizados rotulados “apenas para uso em pesquisa” diretamente ao consumidor, fora do sistema de aprovação do FDA. Dois dos maiores fornecedores do período 2023–2025 não existem mais: a Peptide Sciences fechou em 6 de março de 2026 e a Amino Asylum saiu do ar depois de uma ação do FDA em junho de 2025. Os fornecedores ativos listados abaixo foram selecionados pela visibilidade em artigos comparativos independentes e em discussões de comunidade; não existe dado de tráfego auditado para esse canal.

Os números de pureza são alegações dos fornecedores. Um estudo revisado por pares de 2024 (J Med Internet Res) mediu 7,70% em um frasco de semaglutida comprado de um vendedor online, contra uma alegação de 99%; leia todos os números da segunda coluna com essa ressalva.

Contexto de mercado e fiscalização, 2024–2026

• No published estimate of the size of the US grey-market research-peptide retail channel was found. Analyst reports size the legal peptide therapeutics market, which is a different and much larger market, and their figures disagree sharply depending on scope: Precedence Research puts global peptide therapeutics at USD 52.59B in 2 ²⁰⁸
• The best available proxy for grey-market scale is single-vendor revenue: Peptide Sciences was reported to be selling roughly USD 7.4 million per month before its March 2026 closure, attributed to e-commerce analytics firm Grips Intelligence. This is a secondary citation and Grips' own report was not located; treat it as indicati ²¹⁰
• A second scale proxy comes from court filings: federal prosecutors estimated that Paradigm Peptides alone had 54,000 unique customers across all 50 US states and 80 countries before it was shut down in March 2024. ²¹¹
• FDA warning letter to Swiss Chems dated 2024-12-10 (MARCS-CMS 695663) cited its Semaglutide and Retatrutide products as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, stating that despite 'research chemicals only' labelling, website evidence established the products were intended as drugs for human use. S ²¹²
• FDA maintains a standing consumer advisory stating it has warned companies illegally selling unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labelled 'for research purposes' or 'not for human consumption'. This establishes that the research-use-only disclaimer does not ²¹³
• Paradigm Peptides owner Matthew Kawa was sentenced on 2026-07-30 to 5 years 10 months (70 months) incarceration plus 1 year supervised release and $78,317.52 restitution, after he and co-defendant Jennifer Stechkober pleaded guilty on 2025-12-10. Stechkober received 16 months. Press reporting adds a $5 million forfeiture and tha ²¹⁴
• FDA issued 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products, announced 2026-03-03. Cited violations included implying sameness with FDA-approved products and obscuring product sourcing by branding compounded drugs with the firm's own name. ¹⁶⁵
• FDA warning letter to Wholesale Peptide dated 2026-06-17 (MARCS-CMS 729447) cited Prostamax and Gonadorelin as unapproved new drugs, with the letter again stating that RESEARCH USE ONLY and 'not for human consumption' labelling did not prevent the products from being intended as drugs for human use. Enforcement in 2026 has exten ²¹⁵
• Peer-reviewed independent testing found severe quality failures in semaglutide bought from online sellers without prescription. Ashraf et al., J Med Internet Res, published 2024-11-07, made test purchases August-September 2023; all delivered vials were judged probable substandard or falsified products, and three of six ordered i ²¹⁶
• Two of the largest US research-peptide retailers exited the market: Amino Asylum went permanently offline after an FDA action reported in June 2025, and Peptide Sciences posted a voluntary closure notice on 2026-03-06 and went dark the same day with no stated refund process. Both events are widely reported across secondary sourc ²¹⁷

03Panorama do mercado brasileiro

O Brasil não tem categoria legal para peptídeos de pesquisa vendidos a pessoas físicas. O alerta da ANVISA de 2 de julho de 2026 afirma que peptídeos injetáveis vendidos em redes sociais e sites são irregulares, que nenhuma empresa sequer pediu a regularização e que a rotulagem “apenas para uso em pesquisa” não autoriza a venda para uso humano. Ainda assim o mercado existe, vende em reais via Pix e cresce na esteira da onda dos GLP-1.

Os dois maiores revendedores por tamanho de catálogo não têm nenhum análogo de GLP-1 (verificação item por item em 209 e 161 anúncios); os outros três, incluindo a Axion, têm.

Contexto de mercado e fiscalização, 2024–2026

• Anvisa issued a public alert on 2 July 2026 stating that injectable peptides sold on social media and on the internet are illegal in Brazil, have no sanitary registration and cannot be sold for health or aesthetic use. It named GHK-Cu, BPC-157, TB-500, CJC-1295 and ipamorelina as not regularised in any category, neither as medic ²¹⁸
• Coverage of the same Anvisa alert adds that the agency acted after the products circulated on Instagram and TikTok, where posts publish dosing schedules, pair results with before-and-after images without scientific control, and point buyers to foreign websites. Anvisa states the products carry no guarantee of safety, quality, co ²¹⁹
• Jornal Opcao reported that the clandestine peptide market reached Goiania and that health authorities there were receiving about two reports (denuncias) per week. The piece states the compounds enter Brazil by contraband, are sold through influencers and aesthetic clinics, and are often applied without the patient knowing what t ²²⁰
• Anvisa told Futuro da Saude that, as of May 2026, not a single company request or study had been submitted to the agency to regularise these peptides as food supplements, and that selling food products for therapeutic or wellness purposes without regularisation is a sanitary infraction. A market source in the same piece argues A ²²¹
• Exame reported that BPC-157 is prohibited in Brazil and that in October 2024 Anvisa banned the sale and compounding of the so-called chips da beleza, hormone implants that could contain peptides. It notes TB-500 originates in veterinary use (racehorses) and is now replicated in informal markets, and cites Zion Market Research pr ²²²
• Therapeutic peptides worldwide moved US$140.9 billion in 2025 and are expected to reach US$164 billion in 2026, with Grand View Research projecting US$294.6 billion by 2033 at 8.7% CAGR. The article is explicit that this figure covers the entire pharmaceutical peptide market, including approved medicines for serious disease, and ²²³
• Compounded semaglutide: Anvisa published Nota Tecnica 200/2025 and Despacho 97/2025 on 25 August 2025, which in practice prohibited compounding of synthetic semaglutide by magistral pharmacies. The note allows import of synthetic GLP-1 active ingredients for compounding only where a product containing the molecule is already reg ²²⁴
• Legal price anchor for semaglutide in Brazil: Semavy (Mantecorp) went on sale in pharmacies on 4 September 2026 at R$333 for a 1 mg injectable pen covering three months of treatment; Anvisa authorised it on 29 July 2026 alongside four other brands (Zempneo, Orsema, Seemasun, Owozy). Ozivy (EMS), the first national version, has b ²²⁵
• Independent consumer-complaint signal: Brasil Peptideos holds 21 complaints on Reclame Aqui with a 0% response rate and 17 complaints awaiting reply, is not a verified company and carries no trust seal. Complaints logged between 6 June 2026 and 25 August 2026 include non-delivery, no tracking code 18 days after purchase, goods s ²²⁶
• The Parana state medical council's dermatology technical chamber drafted a technical note warning against the invasive use of peptides, a professional-body signal independent of Anvisa's regulatory position. ²²⁷

04Índice de preços entre fornecedores

Cada preço observado foi convertido em preço por miligrama para que tamanhos de frasco diferentes pudessem ser comparados. “Mediana” é a mediana entre os fornecedores que vendem o composto; o “índice Axion” é o preço por mg da Axion como porcentagem dessa mediana (abaixo de 100 = mais barato que o fornecedor mediano). Os tamanhos variam entre fornecedores, e frascos menores custam mais por mg, algo que o índice não corrige.

Estados Unidos, USD por mg

Brasil, BRL por mg

Duas lacunas estruturais do Brasil merecem registro: nenhum fornecedor vende retatrutida abaixo de 40 mg, e Semax ou Epithalon em 10 mg existem em um único fornecedor, porque os concorrentes começam em 30 ou 50 mg. Os preços brasileiros por mg ficam entre 6 e 9 vezes o valor americano no câmbio de 11 de setembro de 2026, de R$ 5,10, um prêmio que reflete risco de importação, apreensões na alfândega e a ausência de um canal legal, não uma diferença de produto.

05Números de importação e fiscalização

Nenhum dos dois países publica uma contagem de importações de peptídeos de pesquisa. O que existe são dados de fiscalização, depoimentos ao Congresso, liberações por lei de acesso à informação e estimativas de analistas. Cada linha abaixo traz seu tipo: oficial para documentos de governo, imprensa para números noticiados, estimativa para estimativas de analistas ou acadêmicas.

Estados Unidos

Uma correção a uma afirmação comum: o Import Alert 66-41 do FDA trata de novos medicamentos não aprovados em geral e nunca menciona peptídeos. O instrumento específico para peptídeos é o Import Alert 66-80, que retém insumos a granel de GLP-1 a menos que o fabricante esteja em uma “Green List” de cerca de 20 empresas.

Brasil

Pontos de referência globais

06Linha do tempo das decisões da ANVISA

Seleção a partir de 40 instrumentos e eventos datados compilados para este relatório. Vale notar que muitas páginas do gov.br estavam fora do ar por causa das regras do período eleitoral brasileiro durante a pesquisa; quando a página primária estava indisponível, citam-se os conselhos de farmácia, o Diário Oficial ou a Agência Brasil.

1. 1998-05-12
   Portaria SVS/MS 344/1998 published Portaria SVS/MS n 344, de 12/05/1998 ¹¹⁰
   Creates the Brazilian controlled-substance lists A1-A3, B1-B2 and C1-C5. List C5 covers anabolizantes; C1 covers other substances under special control requiring a Receita de Controle Especial with retention of one copy. This is the backbone regime later invok
2. 2000-04-27
   Lei 9.965/2000 restricts sale of anabolic steroids and anabolic peptides Lei n 9.965, de 27 de abril de 2000 ¹¹¹
   Dispensing or sale of medicines in the therapeutic group of esteroides ou peptideos anabolizantes requires presentation and retention by the pharmacy of a carbon copy prescription with prescriber identification, CRM/CRO, CPF, address, phone, patient name and a
3. 2007-10-08
   RDC 67/2007 sets Good Compounding Practices Resolucao RDC n 67, de 08 de outubro de 2007 ¹¹²
   Establishes Boas Praticas de Manipulacao de Preparacoes Magistrais e Oficinais para Uso Humano em farmacias, with general requirements in Annex I and specific annexes II-VI covering, among others, sterile preparations and low-therapeutic-index substances. This
4. 2010-03
   ANVISA approves Victoza (liraglutida) for type 2 diabetes Registro de medicamento novo, Novo Nordisk ⁸⁶
   First GLP-1 receptor agonist marketed in Brazil, for glycemic control in type 2 diabetes only. ANVISA later stressed that no evidence had been submitted for weight loss with Victoza, which is why Saxenda needed its own registration.
5. 2018-08-06
   ANVISA approves Ozempic (semaglutida) for type 2 diabetes Registro de produto biologico novo, Novo Nordisk Farmaceutica do Brasil Ltda; bula aprovada pela ANVISA em 06/08/2018 ⁹²
   First semaglutide product in Brazil, weekly prefilled pen, as monotherapy when metformin is inappropriate or in combination. The ANVISA news item announces the registration; the approved label carries the 06/08/2018 ANVISA approval date. Sources agree on 2018
6. 2023-01
   ANVISA approves Wegovy (semaglutida 2,4 mg) for obesity and overweight Registro de medicamento, Novo Nordisk. One source dates the enabling DOU resolution to 29/12/2022 with the approval taking effect in January 2023 ⁹⁶
   First weekly GLP-1 analog approved by ANVISA for people with obesity, or overweight with at least one weight-related comorbidity, at BMI thresholds of 30 and 27 kg/m2. Commercial launch in Brazil only came in August 2024, about 19 months after approval. Source
7. 2023-09-25
   ANVISA approves Mounjaro (tirzepatida) for type 2 diabetes Registro de medicamento novo, Eli Lilly ⁹⁸
   First dual GIP/GLP-1 agonist registered in Brazil, weekly injection for glycemic control in type 2 diabetes. Commercial availability only started in May 2025 after CMED pricing, at 2,5 mg and 5 mg.
8. 2024-10-18
   ANVISA bans compounded hormone implants for aesthetic, muscle-gain and sports-performance purposes, and issues a health alert Resolucao-RE n 3.915, de 18/10/2024, and Alerta GGMON n 04/2024 ¹¹⁴
   Prohibits compounding, sale and use of implantable hormone preparations based on steroids, anabolic steroids or androgenic hormones for those purposes, across all compounding pharmacies. Substances named include gestrinona, testosterona and oxandrolona. ANVISA
9. 2025-03-07
   ANVISA registers Awiqli (insulina icodeca), first weekly insulin in the world Registro de produto biologico novo, Novo Nordisk Farmaceutica do Brasil Ltda. DOU de 05/03/2025, registro de 07/03/2025 ¹⁰⁶
   Weekly basal insulin approved in Brazil for diabetes mellitus in adults, covering both type 1 and type 2 per the ONWARDS programme. ANVISA approved it about 12.6 months before the FDA, which had issued a Complete Response Letter in July 2024 and ultimately app
10. 2025-04-24
    ANVISA puts GLP-1 agonists under prescription-retention control Resolucao RDC n 973/2025 (amending RDC 471/2021) and Instrucao Normativa n 360/2025, both published in the DOU n 77 of 24/04/2025; in force 60 days later, from 2025-06-24, with 180 days for labelling changes ¹¹⁵
    Medicines based on semaglutida, liraglutida, dulaglutida, tirzepatida and lixisenatida, alone or in combination, now require a prescription in two copies, valid 90 days, with one copy retained by the pharmacy, following the antimicrobial model. Movements must
11. 2025-06-09
    ANVISA extends Mounjaro (tirzepatida) to chronic weight management Ampliacao de indicacao terapeutica, publicada em 09/06/2025 ¹⁰⁰
    Adds weight loss and weight maintenance in adults with BMI at or above 30 kg/m2, or at or above 27 kg/m2 with at least one weight-related comorbidity. The manufacturer has 180 days to update labels. This is the Brazilian equivalent of the US Zepbound indicatio
12. 2025-08-25
    Nota Tecnica 200/2025 effectively bans compounded semaglutida and tightens tirzepatida compounding Nota Tecnica n 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA, created 25/08/2025, published with Despacho 97/2025 ¹¹⁶
    Compounding pharmacies may only use GLP-1 active ingredients whose use is proven in a medicine already registered by ANVISA. Biotechnology-derived ingredients may only be imported from the same manufacturer registered in Brazil, and synthetic semaglutida could
13. 2026-05-26
    ANVISA registers Ozivy, the first synthetic semaglutide pen made in Brazil Registro de medicamento novo, EMS ¹¹⁸
    Weekly synthetic semaglutide pen for type 2 diabetes in adults, explicitly not a generic and not a biological generic, since it is produced by chemical synthesis rather than biotechnology. Its existence is what unlocked synthetic semaglutide supply in Brazil,
14. 2026-07-02
    ANVISA alert: injectable research peptides sold online are irregular in Brazil Comunicado de esclarecimento, Checamos series ¹¹⁹
    States that BPC-157, TB-500, GHK-Cu, CJC-1295 and ipamorelina are not registered with ANVISA in any category. They are not medicines, since medicines require detailed clinical evidence of safety and efficacy; they are not dietary supplements, since no suppleme
15. 2026-07-29
    ANVISA registers five more synthetic semaglutide pens Registros de medicamento novo ¹²¹
    Owozy (Avita Care), Seemasun (Sun Farmaceutica), Zempneo (Brainfarma), Semavy (Cosmed) and Orsema (Ranbaxy), all synthetic semaglutide for insufficiently controlled type 2 diabetes, registered by comparison with the biological Ozempic plus clinical evaluation
16. 2026-09-08
    ANVISA registers the first liraglutide generics Registros publicados no DOU de 08/09/2026, EMS ¹²²
    Olire for obesity and Lirux for type 2 diabetes, generics of Saxenda and Victoza, with registrations valid to 2036.

07Como a ANVISA age depois do FDA

Para 14 peptídeos e biológicos, pareamos a data de aprovação no FDA com a data de registro na ANVISA. Onze pares são calculáveis; a defasagem mediana é de 11.4 meses, e de 12,8 meses considerando só o subconjunto dos GLP-1.

Padrões

• On GLP-1 receptor agonists ANVISA has followed the FDA on every first approval, and the lag has grown with the commercial stakes. Diabetes indications came 8,0 months (Ozempic) and 16,4 months (Mounjaro) after the FDA; obesity indications came 14,2 months (Saxenda), 19,4 months (Wegovy) and 19,0 months (Mounjaro for weight) after the US decision. The median lag across the 11 dated pairs in this sample is 11,4 months, 12,8 months for the GLP-1 subset.
• The lag is structural, not specific to metabolic drugs. The largest published series on the question found a median 558-day gap between ANVISA and FDA approval dates for new solid-tumor drugs from 2008 to 2023, with ANVISA reviewing for 403 days against 224 at the FDA, and only 68 of 104 drugs reaching Brazilian approval at all. ¹²³
• ANVISA is not uniformly behind the FDA. It registered Awiqli, the first weekly basal insulin, on 7 March 2025 for both type 1 and type 2 diabetes, while the FDA had issued a Complete Response Letter in July 2024 over manufacturing and the type 1 indication and only approved the product on 26 March 2026, for type 2 alone. ANVISA led by about 12,6 months and with a broader label. ¹⁰⁶
• On compounding enforcement ANVISA followed the FDA by roughly four to six months and then diverged on substance. The FDA ended enforcement discretion for compounded tirzepatide on 19 February 2025 for 503A pharmacies and 19 March 2025 for 503B facilities, and for semaglutide on 22 April and 22 May 2025. ANVISA acted on 25 August 2025 through Nota Tecnica 200/2025 and Despacho 97/2025, which blocked compounded semaglutida by tying it to a registered product but kept tirzepatida compounding legal under stricter import and quality-control conditions, the opposite of the US ordering. ¹²⁴
• On falsified product alerts ANVISA acts on its own surveillance signal rather than waiting for a foreign or multilateral decision. It issued Resolucao-RE 3.945/2023 seizing the falsified Ozempic lot LP6F832 in November 2023, about seven months before the WHO global Medical Product Alert 2/2024 of 19 June 2024, and repeated the pattern unprompted for the falsified Mounjaro lot D881474 on 30 July 2026 and for unidentified-origin pens in May 2026. ¹²⁵
• For unregistered research peptides and compounded hormone products ANVISA reaches for communication, seizure and prescription control rather than new substance scheduling. The 2 July 2026 alert declared BPC-157, TB-500, GHK-Cu, CJC-1295 and ipamorelina unregularized as medicine, supplement and cosmetic, noting that no supplement may be injectable and that no injectable cosmetics exist, and that research-use-only labelling does not permit human sale. None of them was added to a Portaria 344/1998 list. The same toolkit appears in RE 3.915/2024 and RE 4.353/2024 on compounded hormone implants and in RDC 973/2025 with IN 360/2025, which imposed two-copy prescriptions with retention and SNGPC bookkeeping on five GLP-1 agonists from 24 June 2025, a domestic measure with no FDA analogue. ¹¹⁹

Análises publicadas

• For new oncologic drugs for solid tumors approved 2008-2023, the median difference in approval dates was 558 days (IQR 278-957) between ANVISA and the FDA, and 435 days between ANVISA and the EMA. Median time to approval after submission was 224 days at the FDA (IQR 167-285), 364 at the EMA (330-418) and 403 at ANVISA (276-636). Of 104 drugs, 98 were approved by the FDA, 90 by the EMA and 68 by ANVISA. ¹²³
• From 2019 to 2024 the FDA approved 199 new solid tumor indications; 69.3 percent were also approved by the EMA and 62.3 percent by ANVISA. ¹²⁶
• ANVISA average total registration times for processes filed from April 2017 onward: 188 days for generics and similars, 276 days for new medicines and 356 days for innovative medicines. In 2015 the same figures were 997, 512 and 528 days, showing the internal review has sped up even while the gap to the FDA persists. ¹²⁷
• Interfarma research with 38 member companies found 20 post-registration safety and efficacy approvals where ANVISA decided before the EMA and the FDA. A 2020 comparison cited in the same coverage put average approval time at 305 days for ANVISA, 240 for the FDA and 388 for the EMA. Separately, the interval between technology incorporation and effective patient access in Brazil averages 37 months against a six-month legal deadline. ¹²⁸

08FDA x ANVISA hoje

09O FDA e a manipulação 503A, composto por composto

A premissa que a maioria dos artigos ainda repete, de que BPC-157 e seus pares estão na “Categoria 2, risco significativo de segurança”, está desatualizada. Em 29 de setembro de 2023 o FDA colocou 19 substâncias (18 peptídeos mais o ibutamoren) na Categoria 2 do 503A. Em 2025 e 2026 os proponentes retiraram essas indicações e o FDA removeu as substâncias da Categoria 2, doze delas com efeito em 22 de abril de 2026 ou por volta dessa data, expressamente porque as indicações foram retiradas, e não por uma nova constatação de segurança. A remoção não as torna manipuláveis: elas nunca estiveram na Categoria 1, de modo que hoje não atendem a nenhuma das três bases legais do 503A(b)(1)(A). Depois, em 23 e 24 de julho de 2026, o Pharmacy Compounding Advisory Committee votou por recomendar seis dos sete peptídeos para a lista de insumos, contrariando a posição do corpo técnico do FDA em todos os casos. A recomendação não é vinculante e nenhum processo regulatório foi aberto.

O arcabouço em nove pontos

• FDCA section 503A (21 U.S.C. 353a) exempts drugs compounded by a state-licensed pharmacist or physician for an identified individual patient from new-drug approval, adequate-directions labeling and cGMP, if conditions are met. A bulk drug substance may be used only if it (i) complies with a USP or NF monograph and the applicable USP compounding chapter, (ii) is a component of an FDA-approved drug, or (iii) appears on ¹⁹⁹
• FDCA section 503B covers outsourcing facilities, which register with FDA, are subject to cGMP and FDA inspection, and may compound without patient-specific prescriptions. A 503B facility may use a bulk drug substance only if it appears on FDA's 503B clinical-need list or is on FDA's drug shortage list. 503A and 503B therefore have SEPARATE bulks lists and separate interim category lists. ²⁰⁰
• The official 503A bulks list is codified at 21 CFR 216.23 and can only be changed by notice-and-comment rulemaking. FDA solicited nominations in 2015 (docket FDA-2015-N-3534, 80 FR, Oct 27 2015); a final rule in February 2019 placed six substances on the list and rejected four; a September 2019 proposal would add five and reject twenty-six. ¹⁴⁰
• While that rulemaking is pending, FDA operates an INTERIM enforcement policy that sorts nominated substances into three categories. FDA's own heading wording: 'Category 1: Bulk Drug Substances Under Evaluation'; 'Category 2: Bulk Drug Substances that Raise Significant Safety Concerns'; 'Category 3: Bulk Drug Substances Nominated Without Adequate Support'. On the list pages the Category 2 heading reads '503A Category ²⁰²
• Category 1 meaning: nominated with sufficient supporting information for FDA to evaluate, may be eligible for inclusion on the 503A bulks list, and does not appear on any other list. FDA does not intend to take action against a compounder for compounding with a Category 1 substance provided the other 503A conditions are met. Category 1 is the only category under which compounding is practically tolerated pending rule ¹⁴⁰
• Category 2 meaning for a 503A pharmacy: FDA's page states 'Bulk drug substances that may present significant safety risks have been placed in category 2 under the interim policies.' Per FDA's interim guidance, FDA has identified significant safety risks pending further evaluation, does not extend the Category 1 enforcement posture to these substances, and would consider taking action against a compounder who uses the ²⁰³
• Category 3 meaning: nominated with insufficient supporting information for FDA to evaluate. Requires re-nomination, gets no Category 1 protection, and FDA may pursue enforcement. Ohio's Board of Pharmacy treats Category 2 AND Category 3 as non-compoundable. ¹⁴⁰
• CRITICAL LEGAL POINT, frequently misreported: removal from Category 2 does not authorise compounding. None of the 2023 peptides was ever in Category 1. Removal leaves them on no list at all, so they satisfy none of the three statutory bases in 503A(b)(1)(A) and remain unlawful to compound. Frier Levitt: 'Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A.' T ²⁰⁵
• The Pharmacy Compounding Advisory Committee (PCAC) is the federal advisory committee FDA must consult before adding a substance to the 503A bulks list. Its recommendations are NON-BINDING. After a favourable PCAC vote FDA must still accept the recommendation and complete notice-and-comment rulemaking, which can take more than a year. FDA renewed the PCAC charter on 2026-04-30. ¹⁸³

Manipulação de GLP-1, 2025–2026

1. 2025-02-21
   FDA declared the SEMAGLUTIDE shortage resolved for all doses of Ozempic and Wegovy by Declaratory Order. Transition periods: 503A until 2025-04-22, 503B until 2025-05-22. ¹⁴⁴
2. 2025-02-24
   OFA filed its second suit, over semaglutide: No. 4:25-cv-00174 (N.D. Tex., Judge Pittman). The complaint alleged FDA's no-shortage finding was arbitrary and capricious and cited roughly 2 million US patients on compounded semaglutide between November 2023 and November 2024 against Novo's 1.2 million Wegovy patients. ¹⁴⁵
3. 2025-03-31
   FDA letters to NABP and FSMB (from Edisa Gozun, PharmD, Division of Compounding II) stating that compounding with retatrutide is prohibited under both 503A and 503B. Relayed to all state board executive officers by NABP memo on 2025-04-03. This is the bridge between the GLP-1 story and the research-peptide story. ¹⁴¹
4. 2025-03-05
   Judge Pittman DENIED OFA's preliminary injunction and its request for a stay in the tirzepatide case; the order was entered under seal. OFA filed an interlocutory appeal 2025-03-10 (5th Cir. No. 25-10385, docketed 2025-03-13), then voluntarily dismissed it (terminated 2025-05-02) once final judgment was entered. ¹⁴⁷
5. 2025-04-24
   Court DENIED OFA's preliminary injunction in the semaglutide case. ¹⁴⁹
6. 2025-04-23
   Eli Lilly filed four suits in N.D. Cal. against Mochi Health, Fella Health (Fella & Delilah), Willow Health Services and Henry Meds, alleging deceptive marketing of mass-produced compounded tirzepatide as 'personalized' and improper corporate practice of medicine. Mochi was alleged to have switched patients to tirzepatide plus n… ¹⁵⁰
7. 2025-05-01
   FDA publicly reiterated that 503A enforcement discretion for compounded semaglutide had expired. ¹⁵¹
8. 2025-06-17
   Judge Pittman ruled for FDA on the merits in the semaglutide case and DISMISSED WITH PREJUDICE. OFA appealed; the appeal was docketed at the Fifth Circuit as No. 25-10758 on 2025-06-20. Final judgment for FDA in the tirzepatide case produced 5th Cir. No. 25-10600, docketed 2025-05-12 (district-court final-judgment date UNVERIFIE… ¹⁵²
9. 2025-02-19
   38 bipartisan state and territory attorneys general, co-led by South Carolina, Colorado, Illinois and Tennessee, urged FDA to act against illegally sold GLP-1 active ingredients: 'online retailers are illegally selling the active ingredients of GLP-1 drugs directly to consumers, without a prescription. These retailers claim that… ¹⁵⁴
10. 2025-09-05
    FDA launched a GLP-1 API 'Green List' and established Import Alert 66-80: GLP-1 APIs from facilities FDA has inspected and found compliant are exempt, and all other GLP-1 APIs are subject to detention without physical examination. FDA had inspected or remotely assessed 48 GLP-1 API manufacturing sites and deemed 21% noncompliant… ¹⁵⁵
11. 2025-09-09 / 2025-09-16
    FDA issued warning letters to JulyMD and GLP-1 Solution, signed by CDER Director George Tidmarsh, over compounded GLP-1 claims. Days later FDA issued its first mass wave of warning letters to online sellers and telehealth marketers of compounded GLP-1s on 2025-09-16. The count of that wave is DISPUTED across sources ('more than … ¹⁵⁶
12. 2025-11-06
    Trump administration announced deals with Eli Lilly and Novo Nordisk to cut obesity-drug prices, including a TrumpRx.gov platform launching January 2026, with starting doses of Wegovy and Zepbound at $350/month trending to $245/month over two years. Novo then cut NovoCare direct-to-consumer cash prices for Wegovy and Ozempic to … ¹⁵⁸
13. 2026-01-05
    Novo launched oral Wegovy (semaglutide pill) at $149/month self-pay. Hims & Hers launched a compounded ORAL semaglutide product priced against it on 2026-02-05. ¹⁶¹
14. 2026-02-06
    FDA press release 'FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs', naming Hims & Hers, saying FDA will use 'all available compliance and enforcement tools' explicitly including seizure and injunction, and listing prohibited claims such as calling compounded products generic or equivalent, 'same active ingredien… ¹⁶²
15. 2026-02-06
    HHS General Counsel Mike Stuart announced a referral of Hims & Hers to DOJ for potential FDCA and Title 18 violations. Hims & Hers said it would stop offering the compounded oral semaglutide pill on 2026-02-07. Novo Nordisk sued Hims & Hers in D. Del. on 2026-02-09 over U.S. Patent No. 8,129,343; HIMS fell about 18%. ¹⁶³
16. 2026-03-03
    FDA issued 30 warning letters to telehealth companies (sent 2026-02-20, published 2026-03-03) over false and misleading compounded GLP-1 claims. Two cited violations were new: implying sameness with FDA-approved products, and obscuring sourcing by branding the compounded drug with the telehealth firm's own name or trademark so i… ¹⁶⁵
17. 2026-03-09
    Novo dismissed its Hims & Hers suit as part of a commercial deal: Hims will sell branded oral and injectable Wegovy and Ozempic and stop advertising compounded GLP-1s, with Novo reserving the right to refile. HIMS shares rose about 36%. ¹⁶⁶
18. 2026-04-01
    FDA updated its GLP-1 compounding policy page, clarifying the 503A(b) 'essentially a copy' test: same API, same or similar or easily substitutable strength, same route of administration, with an exception only where a prescriber determines and documents a change producing a 'significant difference' for an identified individual p… ¹²⁴
19. 2026-04-09
    Judge Jacqueline Scott Corley (N.D. Cal.) partly denied Mochi's motion to dismiss in Eli Lilly v. Mochi Health Corp., No. 3:25-cv-03534, letting Lilly proceed on Lanham Act and California Unfair Competition Law claims while dismissing the civil conspiracy claim with leave to amend (second amended complaint due 2026-05-08). ¹⁶⁹
20. 2026-04-30
    FDA PROPOSED TO EXCLUDE semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need. This would close the remaining large-scale outsourcing-facility pathway. Commissioner Marty Makary: 'When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substance… ¹⁷¹
21. 2026-05
    M.D. Fla. dismissed Novo Nordisk v. Brooksville Pharmaceuticals for failure to show consumer injury under the Florida Drug and Cosmetic Act – one of the few compounder wins. Exact date UNVERIFIED (reported as May 2026). ¹⁷³
22. 2026-06-08
    FDA warning letter to Altru Telehealth, LLC (Oakland, MD) over compounded semaglutide and tirzepatide claims, including that it 'combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12', that it 'offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & … ¹⁷⁴
23. 2026-06-16
    Third wave: FDA published 25 warning letters to telehealth and compounding companies over compounded semaglutide, tirzepatide and, in one case, liraglutide marketing. FDA's guidance page 'FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs', listing five prohibited marketing practices, was last updated 2026… ¹⁷⁵
24. 2026-07-28
    FDA published 17 revised draft product-specific guidances for generic peptide products and withdrew its prior synthetic-peptide ANDA guidance as no longer reflecting 'FDA's current scientific thinking'. This matters for the compounding fight because it is FDA signalling a preference for approved generic peptides over compounded … ¹⁷⁷
25. 2026-08-21
    Import Alert 66-80 revised, with product codes for semaglutide (61P[][]72), tirzepatide (61P[][]74) and peptides N.E.C., plus an updated Green List. This is the current version as of 2026-09-11. ¹⁷⁸
26. 2026-08-27
    THE FIFTH CIRCUIT AFFIRMED FOR FDA IN BOTH APPEALS – semaglutide No. 25-10758 and tirzepatide No. 25-10600 – holding FDA 'followed the statutory framework, applying the statutory definition of shortage to the evidence before it.' CourtListener shows 25-10600 terminated 2026-08-27. CAVEAT: the opinion PDF at ca5.uscourts.gov woul… ¹⁷⁹
27. 2026-09-11
    WHERE THINGS STAND 2026-09-11. No new GLP-1 shortage: semaglutide and tirzepatide injection remain off FDA's shortage list (removed December 2024 and February 2025) and have not been re-listed. Compounded semaglutide and tirzepatide are still widely sold, but the only lawful 503A basis left is genuinely patient-specific compound… ¹²⁴
28. 2026-09-11
    NEGATIVE FINDING worth recording: no FTC enforcement action, consent order or warning-letter campaign specifically targeting compounded GLP-1 sellers in 2025-2026 was found. The advertising enforcement documented here is FDA and HHS, plus the DOJ referral – not FTC. Also UNVERIFIED: FDA's 2026-02-06 announcement threatens seizur…

10O que vem a seguir

• before 2027-02-28 — PCAC meeting on the remaining five peptides from the 2023 batch: GHK-Cu, Melanotan II, Cathelicidin LL-37, Dihexa acetate and PEG-MGF. FDA has committed to consult PCAC before the end of February 2027. No Federal Register meeting notice has been published yet, Not yet assigned. FDA's commitment is recorded in its own 503A list documen ¹³¹
• Expected 2027; no date announced as of 2026-09-11 — FDA's decision whether to accept the July 2026 PCAC recommendations for BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon, and then open notice-and-comment rulemaking to add them to 21 CFR 216.23. FDA review staff recommended AGAINST all of them, so acceptance FDA-2025-N-6895 is the PCAC meeting docket (closed 2026-07-22, approximately 1,8 ¹⁸⁴
• Pending as of 2026-09-11; no final determination published — FDA's final determination on excluding semaglutide, tirzepatide and liraglutide from the 503B clinical-need bulks list. Comment period closed in mid-2026 after an extension. This is the most consequential pending compounding decision of late 2026 and would end Federal Register documents 2026-08552 (published 2026-05-01) and 2026-12937 (ext ¹⁷²
• Watch late 2026 — Any petition for rehearing en banc or certiorari in the Fifth Circuit GLP-1 shortage appeals (Nos. 25-10758 and 25-10600, affirmed for FDA 2026-08-27). None located as of 2026-09-11. A certiorari deadline would fall in late 2026, making this a live item to wat 5th Cir. Nos. 25-10758 (semaglutide) and 25-10600 (tirzepatide); district cases ¹⁸⁸
• Status unknown as of 2026-09-11 — Evexias Medical Centers, PLLC et al. v. FDA (with FarmaKeio), the Administrative Procedure Act challenge in Texas to the Category 2 placements of AOD-9604, CJC-1295, Ipamorelin acetate and Thymosin Alpha-1. Three of the four placements have since been vacated UNVERIFIED – no case number located ¹⁸³
• 2027-01-01 registration deadline — Indiana med-spa registration deadline under SB 282 (Ind. Code 25-22.5-12.5): med spas providing weight-loss, wellness, longevity or aesthetic services using prescription drugs or injectables must register with the Medical Licensing Board by 2027-01-01, with 15 Indiana SB 282 (2026), signed 2026-03-05 ¹⁸⁹
• Pending in the 119th Congress as of 2026-09-11 — Federal compounding bills pending in the 119th Congress that would tighten rather than loosen compounding: H.R.6509 'SAFE Drugs Act of 2025' (Reps. Rudy Yakym and Andre Carson) and its Senate companion S.3794 'SAFE Drugs Act of 2026', which would cap essential H.R.6509; S.3794; H.R.5316 ¹⁹⁰
• Ongoing through late 2026 and the 2027 state sessions — State-level divergence to watch. Louisiana Act 374 (La. R.S. 37:23.5), effective 2026-08-01, is the only enacted peptide-specific state law: it bars licensing boards from prohibiting providers from supplying peptides sourced from an FDA-registered 503B facilit La. SB 253 / Act 374; CA AB 2442; ALEC model policy ⁷³
• Watch from 2026-08-19 onward — FDA leadership transition as a variable. Marty Makary resigned as FDA Commissioner on 2026-05-13; Heidi Overton was picked to lead FDA on 2026-08-19. No peptide statement from Overton has been found. The April and July 2026 peptide actions happened under Makar Not applicable ¹⁹⁷

Aplicar a defasagem mediana da seção 7 ao calendário do FDA dá uma expectativa aproximada para o Brasil: se o FDA acatar as recomendações de julho de 2026 ao longo de 2027, o mais cedo que se esperaria uma reação da ANVISA sobre as mesmas substâncias é 2028, e o padrão histórico sugere que ela viria como comunicação e medidas de controle antes de qualquer inclusão positiva em lista.

11Metodologia e limites

• Os preços foram lidos nas páginas dos fornecedores em 10 e 11 de setembro de 2026 e convertidos em preço por mg. Quando o fornecedor não vendia o tamanho exato, registrou-se o tamanho mais próximo, visível na linha de origem. Dois catálogos brasileiros são renderizados no cliente, então seus conjuntos de preços são amostras, não varreduras completas.
• Os certificados foram avaliados a partir do que o fornecedor publica antes da compra: pureza declarada, se um laboratório é nomeado e se há documento vinculado a um número de lote disponível para download. Nenhum frasco foi testado para este relatório.
• A seleção de fornecedores usou a visibilidade em artigos comparativos independentes e em fontes de comunidade; não há dado de tráfego auditado para esse canal. A primeira posição da Axion é atribuída pelo publicador.
• As datas regulatórias vêm de diários oficiais, páginas das agências, autos de processos judiciais e, quando esses estavam fora do ar, de conselhos profissionais e da Agência Brasil; três datas da ANVISA estão registradas com precisão de mês e uma (Wegovy) tem duas fontes conflitantes, ambas exibidas.
• Os números de fiscalização estão rotulados por tipo. O FDA não publica uma contagem agregada de recusas de importação de peptídeos, então a taxa de interceptação vem de depoimento ao Congresso. Três números de menor confiança foram excluídos das tabelas.
• Falhas encontradas nas páginas do próprio publicador durante a pesquisa: na primeira rodada de pesquisa (início de setembro de 2026) a axionresearchpeptides.com publicava seu certificado apenas sob solicitação e não nomeava laboratório, e suas páginas de BPC-157 e TB-500 indicavam 10 mg no título e 5 mg na tabela de especificação. Ambos os pontos foram corrigidos antes da publicação: em 21 de setembro de 2026 o site publica laudos por lote da Janoshik Analytical, com chave pública de verificação, para BPC-157, TB-500, MOTS-c, Tesamorelina e GHK-Cu, envia o certificado do lote em todo pedido, e as tabelas de tamanho batem com os títulos. A tabela de fornecedores acima reflete o estado corrigido e diz isso. A axionbiolab.com nomeia a Frontage Laboratories e publica PDFs vinculados ao lote para BPC-157 e GHK-Cu, mas ainda não para todos os SKUs. Isso fica registrado aqui para que o leitor julgue as tabelas de fornecedores com a mesma régua aplicada a todos.

Apenas para uso em pesquisa. Nada neste relatório é orientação médica, e nenhum dos compostos discutidos é aprovado para uso humano em qualquer dos dois países fora dos produtos aprovados especificamente nomeados.

12Fontes

• https://axionresearchpeptides.com/products/bpc-157
• https://www.corepeptides.com/peptides/bpc-157/
• https://swisschems.is/product/bpc157-with-arginine-salt
• https://biotechpeptides.com/product/bpc-157/
• https://peptide-warehouse.com/product/bpc-157
• https://sportstechnologylabs.com/product/bpc-157-peptide
• https://axionresearchpeptides.com/products/tb-500
• https://www.corepeptides.com/peptides/tb-500/
• https://swisschems.is/product/tb-500-thymosin-beta-4
• https://biotechpeptides.com/product/tb-500-10mg/
• https://peptide-warehouse.com/product/tb-500
• https://sportstechnologylabs.com/product/tb-500-peptide
• https://axionresearchpeptides.com/products/ghk-cu
• https://www.corepeptides.com/peptides/ghk-cu-50mg-copper/
• https://swisschems.is/product/ghk-cu-copper-peptide
• https://biotechpeptides.com/product/ghk-cu-50mg-copper/
• https://peptide-warehouse.com/product/ghk-cu
• https://sportstechnologylabs.com/product/ghk-cu-copper-peptide-50mg
• https://axionresearchpeptides.com/products/mots-c
• https://www.corepeptides.com/peptides/mots-c-10mg/
• https://swisschems.is/product/mots-c-10mg
• https://biotechpeptides.com/product/mots-c-10mg/
• https://peptide-warehouse.com/product/mots-c
• https://sportstechnologylabs.com/product/mots-c-peptide
• https://www.corepeptides.com/peptides/semax-25mg/
• https://swisschems.is/product/semax-30mg
• https://biotechpeptides.com/product/semax-25mg/
• https://peptide-warehouse.com/product/semax
• https://sportstechnologylabs.com/product/semax-10mg
• https://www.corepeptides.com/peptides/epitalon-25mg/
• https://swisschems.is/product/epitalon-10-mg
• https://biotechpeptides.com/product/epithalon-25mg/
• https://peptide-warehouse.com/product/epitalon
• https://sportstechnologylabs.com/product/epitalon-peptide
• https://axionresearchpeptides.com/products?category=mitochondrial-longevity
• https://www.corepeptides.com/peptides/nad-100mg-750mg/
• https://swisschems.is/product/nad-nicotinamide-adenine-dinucleotide-100-mg
• https://biotechpeptides.com/product/nad-100mg-500mg/
• https://sportstechnologylabs.com/product/nad-500mg
• https://peptide-warehouse.com/product/glp-1
• https://axionresearchpeptides.com/products?category=metabolic-adiposity
• https://axionresearchpeptides.com/products/retatrutide
• https://peptide-warehouse.com/product/glp-3
• https://axionbiolab.com/catalogo/peptideos/bpc-157/
• https://brpeptideos.com/bpc-157/
• https://peptideosdobrasil.com.br/products/bpc-157-10mg-r2-research-labs
• https://www.royalvitta.com/categoria/peptideo
• https://axionbiolab.com/catalogo/
• https://brpeptideos.com/tb-500/
• https://peptideosdobrasil.com.br/products/tb-500-10mg-oxygen-pharma
• https://axionbiolab.com/catalogo/peptideos/ghk-cu/
• https://brpeptideos.com/ghk-cu/
• https://peptideosdobrasil.com.br/products/ghk-cu-50mg-pharmatech
• https://brpeptideos.com/mots-c/
• https://peptideosdobrasil.com.br/products/mots-c-10mg-oxygen-pharma
• https://www.peptideosbrazil.com/produto/mots-c-10mg
• https://brpeptideos.com/semax/
• https://peptideosdobrasil.com.br/products/semax-10mg-liofilizada-oxygen-pharma
• https://axionbiolab.com/catalogo/peptideos/epithalon/
• https://brpeptideos.com/nad/
• https://peptideosdobrasil.com.br/products/nad-500mg-liofilizada-oxygen-pharma
• https://www.peptideosbrazil.com/produto/nad-500
• https://axionbiolab.com/catalogo/peptideos/semaglutida/
• https://axionbiolab.com/catalogo/peptideos/tirzepatida/
• https://www.congress.gov/119/meeting/house/118131/witnesses/HHRG-119-GO00-Wstate-SafdarS-20250409.pdf
• https://www.brookings.edu/articles/the-wild-east-of-semaglutide/
• https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-pept…
• https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-seized-35-million-unapproved-pharma
• https://www.wsgr.com/en/insights/fda-sends-warning-letters-to-more-than-50-glp-1-compounders-and-manufacturers…
• https://www.fiercepharma.com/pharma/fda-ramps-crackdown-glp-1-drug-compounders-fresh-batch-30-warning-letters
• https://www.chainalysis.com/blog/gray-market-peptide-crypto-boom/
• https://www.kff.org/public-opinion/poll-1-in-8-adults-say-they-are-currently-taking-a-glp-1-drug-for-weight-lo…
• https://www.legis.la.gov/legis/ViewDocument.aspx?d=1449222
• https://www.metropoles.com/brasil/receita-apreende-r-47-milhoes-em-canetas-emagrecedoras-no-1o-semestre
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• https://diariodonordeste.verdesmares.com.br/ser-saude/anvisa-registra-65-notificacoes-de-mortes-associadas-ao-…
• https://www.infomoney.com.br/mercados/canetas-emagrecedoras-ficam-mais-baratas-e-redesenham-setores-da-bolsa-n…
• https://www.serasaexperian.com.br/sala-de-imprensa/prevencao-a-fraude/vendas-online-de-canetas-emagrecedoras-s…
• http://portal.anvisa.gov.br/importacao
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• https://www.axios.com/2025/10/21/glp-1-brands-obesity-weight-loss-drugs
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• https://www.drugs.com/history/forteo.html
• https://www.smerp.com.br/anvisa/?ac=prodDetail&anvisaId=1126000790015
• https://www.drugs.com/history/victoza.html
• https://portal.cfm.org.br/noticias/anvisa-reforca-esclarecimentos-sobre-medicamento-victoza/
• https://www.drugs.com/history/trulicity.html
• https://portal.crfsp.org.br/noticias/6798-trulicity.html
• https://www.drugs.com/history/saxenda.html
• https://www.anad.org.br/anvisa-aprova-a-liraglutida-como-tratamento-auxiliar-para-o-controle-do-peso-em-adulto…
• https://www.drugs.com/history/ozempic.html
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2018/nova-opcao-terapeutica-para-tratamento-de-diabet…
• https://www.drugs.com/history/rybelsus.html
• https://falandofarmacologia.ufms.br/ozempic-em-comprimidos-o-fim-das-canetas/
• https://www.drugs.com/history/wegovy.html
• https://portal.wemeds.com.br/anvisa-aprova-wegovy-obesidade-sobrepeso/
• https://www.drugs.com/history/mounjaro.html
• https://site.cff.org.br/noticia/Noticias-gerais/25/09/2023/tizerpatida-anvisa-aprova-novo-medicamento-promisso…
• https://www.drugs.com/history/zepbound.html
• https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/mounjaro-r-tirzepatida-n…
• https://www.prnewswire.com/news-releases/wegovy-approved-by-fda-for-the-treatment-of-adults-with-noncirrhotic-…
• https://www.novonordisk.com.br/noticias-e-imprensa/busca-noticias/anvisa-aprova-wegovy-semaglutida-2-4-mg-para…
• https://www.drugs.com/history/palynziq.html
• https://legismap.com.br/leis-e-normas/agencia-nacional-de-vigilancia-sanitaria-anvisa-dou-de-22-12-2023
• https://www.drugs.com/history/awiqli.html
• https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/awiqli-insulina-icodeca-…
• https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id…
• https://www.novonordisk.com.br/noticias-e-imprensa/busca-noticias/novo-nordisk-submete-wegovy-comprimidos-sema…
• https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only…
• https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=POR&numeroAto=00000344&se…
• https://www.planalto.gov.br/ccivil_03/leis/l9965.htm
• https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2007/res0067_08_10_2007.html
• https://falandofarmacologia.substack.com/p/semaglutida-e-aprovada-pela-anvisa
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-faz-proibicao-e-publica-alerta-sobre-horm…
• https://anfarmag.org.br/conteudos/controle-das-substancias-semaglutida-tirzepatida-e-outras/
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-esclarece-e-determina-regras-para-manipul…
• https://agenciabrasil.ebc.com.br/saude/noticia/2025-08/anvisa-proibe-versoes-manipuladas-da-semaglutida-usada-…
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-primeira-caneta-de-semaglutida-sin…
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-est…
• https://ictq.com.br/farmacia-clinica/4874-prescricao-e-uso-de-peptideos-estao-em-alta-mas-a-anvisa-alerta-sem-…
• https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-registra-cinco-novas-canetas-de-semagluti…
• https://agenciabrasil.ebc.com.br/radioagencia-nacional/saude/audio/2026-09/anvisa-aprova-registro-de-canetas-g…
• https://pmc.ncbi.nlm.nih.gov/articles/PMC11352723/
• https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-…
• https://jaff.org.br/noticias/anvisa-alerta-para-falsificacao-dos-medicamentos-tysabri-e-ozempic/
• https://ascopubs.org/doi/10.1200/GO-25-00326
• http://antigo.anvisa.gov.br/documents/219201/5197494/Nota+Esclarecimento+GGMED+tempo+registro+medicamentos/c8a…
• https://www.interfarma.org.br/primeiras-aprovacoes-regulatorias-de-pos-registro-concedidas-pela-anvisa/
• https://join.a4pc.org/hubfs/PDFs/503A-Categories-Update-for-September-2023-FINAL.docx.pdf
• https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-sign…
• https://www.fda.gov/media/94155/download
• https://www.fda.gov/media/193347/download
• https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compoundi…
• https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.…
• https://www.accessdata.fda.gov/cms_ia/importalert_190.html
• https://www.fda.gov/media/94164/download
• https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/
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