Regulation

Prescribing, importing, administering: a physician's legal map in Panama

Law 419 of 2024, Executive Decree 27, the Penal Code, Law 68 and the Ethics Code. What they say, article by article, about unregistered products, personal import, advertising and consent.

Published October 9, 2026 · 4 min read · 14 sources

Why this map matters now

Patients arrive with products bought on social media, vials from other countries or treatments heard about on podcasts. The World Health Organization warns that substandard and falsified medical products are often sold online or in informal markets9, and a meta-analysis estimated that 13.6% of essential-medicine samples tested in low- and middle-income countries were of poor quality10. Panama's legal framework was renewed in 2024 with Law 419 on medicines and its regulation, Executive Decree 2712. This is a summary of the articles that most affect clinical practice.

Law 419 of 2024: registration and sanctions

  • Art. 156.1 classifies as a very serious offense "marketing a product without sanitary registration, except for the exceptions authorized by this Law"1.
  • Art. 156.2: it is also very serious to "distribute or dispense contaminated, altered, falsified or adulterated products"1.
  • Art. 150: fines "from five hundred balboas (B/.500.00) to twenty-five thousand balboas (B/.25,000.00)", "without prejudice to civil or criminal action"; for very serious offenses the fine ranges from B/.15,001 to B/.25,0001.
  • Art. 3(71) defines a prescription as one "issued by a qualified physician"1.
  • In practice: in August 2026 MINSA inspected two establishments offering stem cell therapies and opened administrative files over possible violations, including the presence of products without sanitary registration11. Panamanian researchers had warned that lack of enforcement facilitated the growth of that market14.

Import and registration exceptions: Executive Decree 27

Personal-use import by courier or traveler requires a prescription from a "qualified professional", and the quantity "must not exceed six months of treatment". Also: "The import of raw material or unfinished products through courier services or travelers is not permitted" (art. 358.3)2.

An exception to sanitary registration for a patient requires a prescription and registration of the product by a "high-standard regulatory authority" (art. 209); it is valid for 60 business days with no extension (art. 214) and is free for the patient2. A peptide not registered by any high-standard agency does not fit that pathway; this is an inference from the cited articles, not a MINSA ruling12. For reference: USADA states that BPC-157 is not approved for human clinical use by the FDA or by any health authority worldwide8. The FDA, reviewing its possible use in compounding, cited a possible immunogenicity risk and no or only limited safety information; for the thymosin β4 fragment known as TB-500 it said it has not identified any human exposure data7.

B/.25,000maximum fine under Law 4191
6 monthsof treatment, personal-import cap2
60 daysbusiness-day validity of the registration exception2

Penal Code: crimes against public health

  • Art. 304: whoever "poisons, contaminates, alters or corrupts food, medicine, excipient or raw material", 4 to 10 years in prison3.
  • Art. 305: delivering a medicine "knowing it to be harmful", 3 to 6 years3.
  • Art. 306: if illness results, 6 to 12 years; if death results, the penalties for aggravated homicide3.
  • Art. 309: "A physician or person with a health career who prescribes or supplies a drug without medical or therapeutic need to justify it or in a dose greater than necessary", 1 to 3 years in prison or the equivalent in day-fines or weekend arrest3.
  • Art. 381: practicing a profession without the required qualification, 2 to 5 years3.

Note: the text consulted is the 2019 consolidated version published by the Public Ministry; we did not verify later amendments3.

Written consent is mandatory for procedures "involving notable and foreseeable risks or drawbacks" (art. 16), and it "must be specific to each procedure" (art. 17)4. With products of limited evidence, documenting what is and is not known about the product is part of that consent. The legal literature agrees: with off-label or unlicensed medicines, the duty to inform the patient about benefits and risks is stricter12.

Advertising and social media

Art. 140 of Law 419 prohibits recommending treatments through mass media, and health professionals who take part in mass media for teaching purposes "may not use trade names or recommend particular brands of medicines"1. In January 2026 the Medical Association reminded members that its Ethics Code prohibits promotional use of patient testimonials that breaches confidentiality and the promotion of treatments without scientific support, and asked them to "avoid sensationalism and the promise of guaranteed results"5. There is precedent for MINSA sanctioning a physician over public statements: a $6,000 fine in 2022 for vaccine misinformation6. A review of 88 studies identified, among the risks of social media for health professionals, breaches of confidentiality and legal and disciplinary consequences13.

Sources

  1. República de Panamá. Ley 419 de 1 de febrero de 2024, que regula los medicamentos y otros productos para la salud humana (texto vía vLex). vlex.com.pa ↗
  2. Ministerio de Salud de Panamá. Decreto Ejecutivo 27 de 10 de mayo de 2024 (Gaceta Oficial 30028-C). minsa.gob.pa ↗
  3. Ministerio Público de Panamá. Código Penal de la República de Panamá, texto único (2019). ministeriopublico.gob.pa ↗
  4. República de Panamá. Ley 68 de 20 de noviembre de 2003, que regula los derechos y obligaciones de los pacientes en materia de información y de decisión libre e informada. gorgas.gob.pa ↗
  5. Samaniego A. Colegio Médico advierte sobre publicidad médica y tratamientos sin evidencia. La Prensa (Panamá). 4 de enero de 2026. prensa.com ↗
  6. Panamá América. Médicos aplauden la sanción impuesta por el Minsa a la doctora Marta Roa. 17 de febrero de 2022. panamaamerica.com.pa ↗
  7. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (BPC-157; Thymosin beta-4 fragment [LKKTETQ], TB-500). Actualizado el 22 de abril de 2026. fda.gov ↗
  8. USADA. BPC-157: What Athletes Should Know About the Prohibited Experimental Peptide. Consultado el 25 de octubre de 2026. usada.org ↗
  9. Organización Mundial de la Salud. Substandard and falsified medical products (nota descriptiva). 3 de diciembre de 2024. who.int ↗
  10. Ozawa S, Evans DR, Bessias S, et al. Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. JAMA Netw Open. 2018;1(4):e181662. PubMed 30646106 ↗
  11. Samaniego A. Minsa abre investigación a locales que ofrecen tratamientos con células madre. La Prensa (Panamá). 31 de agosto de 2026. prensa.com ↗
  12. Aagaard L, Kristensen K. Off-label and unlicensed prescribing in Europe: implications for patients' informed consent and liability. Int J Clin Pharm. 2018;40(3):509-512. PubMed 29721740 ↗
  13. Vukušić Rukavina T, Viskić J, Machala Poplašen L, et al. Dangers and Benefits of Social Media on E-Professionalism of Health Care Professionals: Scoping Review. J Med Internet Res. 2021;23(11):e25770. PubMed 34662284 ↗
  14. Solis MA, Quintana M, Candanedo P JE, et al.; Members of the National Research Bioethics Committee. Unproven stem cell-based interventions marketed as treatments in Panama: An urgent call for enforcement actions. Stem Cell Reports. 2026;21(8):103017. PubMed 42492512 ↗

Informational article. It summarizes news, official statements and published studies; it is not medical or legal advice. Sources were checked on the publication date.

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