Brazilian Pharmacy Council authorizes pharmacists to prescribe legend medicines and establishes Specialist Qualification ID

On March 17, 2025, the Brazilian Federal Pharmacy Council (CFF) published CFF Resolution No. 05/25, which provides for the establishment of patients’ pharmacotherapeutic follow-up profiles by pharmacists according to Law No. 13,021/14, which provides for the practice and supervision of pharmaceutical activities.

In order to prescribe prescription-only medicines, pharmacists must be specialized in clinical pharmacy to comply with the new resolution establishing the national qualification register for pharmaceutical specialties (detailed below).

In addition, the clinical pharmacy Specialist Qualification ID (RQE) requirement to prescribe prescription-only medicines will not apply to programs in the Brazilian Unified Health System (SUS) and regulations or in case there are specific CFF resolutions that prevent its enforcement.

Among the pharmacists’ responsibilities, the new resolution provides for the semiology process, which includes:

• Tracking, identifying, and evaluating patients’ needs to ensure pharmacotherapeutic efficiency;
• Notifying adverse events to medicines; and
• Managing self-limiting diseases, chronic conditions, and emergencies, directing patients to adequate healthcare services whenever necessary.

Specialist Qualification ID (RQE)

On March 17, 2025, the CFF published CFF Resolution No. 04/25, which provides for the RQE and establishes criteria and procedures for pharmacists to obtain it.

In this regard, pharmacists must register their specialties with the regional council by submitting diplomas and certificates attesting to recognized qualifications, such as graduate degrees, residency programs, or other qualifications, in addition to meeting the criteria set out in the new resolution.

Among other provisions, the new resolution establishes that:

• The RQE may include annotations regarding the pharmacist’s subspecialties;
• Only pharmacists who hold an RQE in a specific area can present themselves as specialists;
• A CFF resolution will define which pharmaceutical specialties will be eligible for an RQE.

Legal dispute

On March 20, 2025, the Brazilian Federal Council of Medicine (CFM) filed Public-Interest Civil Action (ACP) No. 1024895-51.2025.4.01.3400 against the CFF, requesting the immediate suspension of the new resolution and that the CFF be banned from enacting further regulations on the matter.

The controversial matter had already been disputed between the two councils before the Federal Regional Appellate Court of the 1st Region (TRF-1), within the scope of ACP No. 0060624-78.2013.4.01.3400, filed by the CFM against the CFF in 2013.

At the end of 2024, TRF-1 suspended CFF Resolution No. 586/13, which provided for the prescription of medicines by pharmacists. The court decided that the resolution overstepped the regulatory limits of the profession.

According to the CFM, the new CFF resolution seeks to “subvert the legal order to keep the content of CFF Resolution 586/13 in force”.[1]

It should be noted that CFF Resolution No. 586/13 was published before Law No. 13,021/14, which provides for the practice and supervision of pharmaceutical activities. In this regard, the current CFF Resolution No. 05/25 establishes the legal basis for prescribing legend medicines within the scope of the pharmacotherapeutic profile established in regular patient follow-ups, which article 13, V of Law No. 13,021/14 provides for.

The ACPs filed by the CFM against the CFF reflect an ongoing dispute regarding the scope of professional skills and safety medicines prescription, which impact the entire Brazilian healthcare ecosystem. We must acknowledge that such institutional dispute undermines collaboration between health professionals and can compromise patient safety.

Finally, the systematic and coherent interpretation of the legal system is essential for each professional council to enact regulations within its legal competence and in accordance with applicable laws, considering that a patient’s journey involves professionals of multiple specialties, which are all critical to their maintenance and recovery of good health.

Demarest’s Life Sciences and Healthcare team will continue to monitor the topic and is available to provide any further clarifications that may be necessary.

Update:

On March 31^st, 2025, the 17^th Federal Civil Court of the Federal District Court granted the preliminary injunction requested by the CFM, ordering the suspension of the new resolution until a final court decision on the matter.

We will continue to monitor developments on this topic.

[1] Public-Interest Civil Action No. 1024895-51.2025.4.01.3400