COFEN Rule #801/2026 was published in the Federal Register on January 22, 2026. The Rule establishes guidelines for the prescription of medications by nurses within the scope of the Nursing Process. The regulation governs a practice already provided under Statute #7,498/1986 and is related to the update introduced by Anvisa (Brazil’s FDA) in 2025 to the National System for the Management of Controlled Products (SNGPC), which began to allow the professional registration of nurses for purposes of sanitary monitoring.

The publication of COFEN Rule #801, dated January 14, 2026 (“Rule”), represents an important milestone in the regulation of the activities of nursing professionals in Brazil, especially with regard to the prescription of medications. By establishing clear guidelines for this practice within the scope of the Nursing Process (a work method set forth in COFEN Rule #736/2024), the Federal Nursing Council (COFEN) regulates the authority provided for in Statute #7,498/1986 (Article 11, item I, subitem c).

The Rule is supported by a set of constitutional and infraconstitutional norms. Key legal foundations include Article 196 of the Brazilian Constitution, which establishes health as a right of all and a duty of the State, and Article 5, item XIII, which ensures freedom of professional practice, subject to legal qualifications.

At the infraconstitutional level, the Rule is based primarily on Statute #7,498/1986, which regulates the practice of nursing, and its regulatory decree, Decree #94,406/1987. These instruments already authorize nurses to prescribe medications included in public health programs and in routines approved by healthcare institutions. In addition, Statute #8,080/1990 defines comprehensive therapeutic assistance as part of Brazil’s Public Healthcare System (“SUS”) activities, including pharmaceutical care.

Another relevant aspect highlighted by the Rule is the recognition that the prescription of medications is not defined by the Medical Act Statute (Statute #12,842/2013) as an activity exclusive to physicians, provided that legal limits and applicable protocols are observed.

The Rule establishes that the prescription of medications by nurses must occur exclusively within the context of the nursing consultation, as one of the stages of the Nursing Process. This requirement reinforces the technical, systematic, and evidence-based nature of the practice, ruling out any interpretation of indiscriminate prescription or prescription detached from the patient’s clinical assessment.

The regulation further determines that prescriptions must always be linked to institutional protocols, clinical guidelines and SUS regulations, or to officially established public health programs. It also imposes specific rules regarding prescription traceability, professional identification, medical record documentation, and compliance with sanitary regulations, especially with respect to medications subject to special control.

The Rule also standardizes prescription forms and regulates the formal aspects of prescriptions, including those issued electronically, requiring electronic signatures that comply with current legislation and Anvisa’s regulations.

A notable feature is the creation of a reference list of medications intended to support local protocols, covering areas such as sexually transmitted infections, reproductive health, prenatal care, chronic diseases, and prophylaxis. This list includes antibiotics, contraceptives, medications for the treatment of hypertension and diabetes, drugs used in prenatal care and in prophylactic strategies, as well as medications used in HIV PrEP and PEP, such as tenofovir, lamivudine, and dolutegravir.

It was also established that states and municipalities retain autonomy to expand this list, provided there is scientific and epidemiological support.

From the perspective of SUS, the Rule is expected to positively impact the organization of care, especially in primary healthcare units, women’s health programs, and in the management of chronic and infectious diseases, as well as preventive initiatives. By providing greater normative clarity regarding the role of nurses, the rule helps reduce care bottlenecks and enables more agile responses to the population’s needs.

The Rule represents an important step in consolidating the technical autonomy and ethical responsibility of nursing professionals in Brazil. It also stimulates debate by highlighting the importance of an integrated interpretation of the legal framework and a broader understanding of healthcare, centered on the patient and on the effectiveness of public policies.

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