AFE, AE and Anvisa: what a regularized compounding pharmacy means

When a clinic prescribes compounded preparations, the question that really matters is not “is this pharmacy good?” but “is this pharmacy regularized?”. Sanitary regularity is the foundation any quality assessment rests on. Understanding the acronyms behind that regularity helps the prescriber make safer decisions.

AFE — Company Operating Authorization

The AFE is granted by Anvisa (Brazil’s health authority) and authorizes the company to carry out activities with medicines and inputs. It is the first document that distinguishes a formally enabled compounding pharmacy from an irregular operation. Without an AFE, there is no basis to speak of safety.

Special Authorization (AE)

The Special Authorization is required of pharmacies that compound substances subject to special control (listed in Ordinance 344/98). Many protocols — including injectables and hormonals — involve controlled substances, and the AE is what lets the pharmacy work with them legally.

Sanitary license and technical director

Beyond the federal documents, the pharmacy needs a local sanitary license and a pharmacist technical director (RT). The RT is technically responsible for compounding — the one who ensures good practices are followed day to day.

Why this is the prescriber’s problem

Sanitary responsibility lies with the pharmacy, but the reputation of whoever prescribes is on the line. A compound produced outside regularity exposes the patient and the clinic. That’s why we always recommend verifying, or requiring, up-to-date documentation.

At PharmaLinker, the pre-qualification of each partner pharmacy includes checking this regularity, and the documents are gathered in a sanitary dossier available to the clinic. It’s how you turn “trust” into evidence.

Read also

• Sanitary dossier: the document every clinic should require
• Per-batch report: what every prescriber should require
• How PharmaLinker works

Informational content for healthcare professionals. PharmaLinker is a B2B intermediation platform that connects physicians and clinics with licensed compounding-pharmacy partners (regulated by Anvisa, Brazil’s health authority); it does not sell medicines, make therapeutic claims, or replace clinical judgment. Compounded preparations require a prescription.