Pharmacists may prescribe restricted sales medicines from April 16, according to Resolution No. 05/2025 published by the Federal Council of Pharmacy (CFF).
The measure, however, already faces strong resistance. In addition to public civil action filed in the Federal District Court by the Federal Council of Medicine (CFM) last Thursday (20), a project of Legislative Decree (PDL 134/2025) was filed on Tuesday (25) in the Federal Senate by Senator Dr. Hiran (PP-RR) with the objective of blocking the norm.
What do you say?
In the CFM’s understanding, “the CFF act violates Law No. 12,842/2013, which establishes private activities of the doctor, as well as illegally expanding the competence of pharmacists; reissue a similar measure already overthrown by the judiciary itself and endanger the health of the population,” says the council in a statement.
The CFM argues that pharmacists have no legal attribution or medical technical preparation to identify diseases, define treatments and measures to restore the health of affected people of various diseases.
In turn, Senator Dr. Hiran stated that the measure is contrary to Law 13.021/2014, which guides the activity of pharmacists, and Law 12.842/2013 (the law of the medical act) – in line with the CFM – which establishes the prescription as an exclusive attribution of doctors and dentists.
“We have already got signatures to consign the urgency of this PDL and we will, as soon as possible, to vote it here in the Federal Senate,” said the parliamentarian.
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The senator argued that the prescription requires in -depth knowledge of appropriate clinical examinations, diagnosis and treatment, aspects that, according to him, are not part of the formation of pharmacists, but of doctors.
Lawyer Ariane Vilas Boas, a medical defense expert and a member of the OAB-SP Medical Law Commission, recalls the similar resolution of 2013, which had already been the subject of judicial questioning because it allows the prescription of medicines that do not require prescription, such as painkillers and anti-sprinkles.
“At the time, the CFM filed a similar action against Resolution CFF No. 586/2013 and, in November 2024, the court upheld the lawsuit filed by CFM. According to the judge, the resolution is unconstitutional and illegal. And, rightly, the decision reinforces the questions about the legality of the new resolution,” Ariane explains.
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With the new attempt through CFF Resolution No. 05/20255, the CFM resorted to court again. “The purpose of this action is to prevent the pharmacist from performing exclusively medical act, namely the prescription of medicines. Current Resolution No. 05/2025 is another attempt to legalize the prescription, which will probably be barred again by the judiciary,” says the lawyer.
Ariane also warns of the risks of the measure. “Prescribing medication presupposes a diagnosis. And diagnoses and prescriptions can only be made by doctors and dental surgeons, according to their specific legislation,” he says.
Lawyer Washington Fonseca, a medical law expert, also reinforces the caveat. According to him, the competences of anamnesis, prescription and clinical knowledge are restricted to the doctor, with which he learns in all stages of his training – from college, through the boarding school to the residence.
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“The pharmacist has as its main focus on acting to participate in drug production steps, quality analysis and control, handling, dismissal and guidance on drug use”
In addition to legal aspects, the resolution also generates ethical concerns. “It would certainly be unethical the same professional who prescribes receiving selling the medicine,” adds Ariane.
The doctor Caroline Daitx, a specialist in Forensic Medicine and Medical Expertise draws attention to the practical consequences of this expansion of attributions without adequate technical-legal support.
In the analysis of the doctor, the prescription of medicines, especially in cases of acute or complex diseases, requires complete clinical diagnosis, often with complementary examinations – competences considered medical and that may compromise patient safety if delegated to other professionals, even the specialized.
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Caroline points out that this is reflected in the increase in disputes involving medication errors, non -monitored adverse reactions and therapeutic follow -up failures.
“Increasingly, medical experts are called to establish the causal nexus between improper conduct and aggravations of clinical paintings, often difficult to reversing. Expertise is challenged to quantify damage, determine disabilities and analyze conduct in the light of the medical ethics, current legislation and clinical-therapy protocols,” concludes the expert.
