Brazil's federal health regulator has slowed inspections of sterile compounding pharmacies, including businesses that prepare injectable weight-loss pens, after publicly promising tighter control of the sector, according to Folha de S.Paulo.
The report, based on single-source reporting from Folha, says the National Health Surveillance Agency (Anvisa) took part in 30 company visits this year. Thirteen occurred in April during an operation with Brazil's Federal Police (PF). Folha says the last sanitary inspection took place on May 22.
Inspection Pause
Folha also reported that it obtained an internal June 13 order telling inspectors to interrupt visits to pharmacies. The message said the temporary measure was intended to allow the agency to draft a standardized procedure for such actions.
Anvisa denied that version. In a statement cited by Folha, the regulator said its inspection calendar had not changed and that no pharmacy action had been suspended. It said it had stopped inspecting only one distributor.
The agency also said routine oversight belongs to Brazil's state and municipal health surveillance network, while Anvisa focuses on issues that require greater attention.
Rules Still Pending
The slowdown comes as Anvisa remains divided over new rules for the sector. In May, the agency's board began debating a proposal that would require stronger certification for imported raw materials used by pharmacies, plus analysis by the National Institute for Quality Control in Health (INCQS), a laboratory linked to the Fiocruz public health foundation.
The vote was postponed after a request for more time to review the matter and has not returned to the agenda. Folha reported that Anvisa officials say directors disagree on the deadline for the rules to take effect, among other points.
The debate followed a package Anvisa had promised in April, when it said consumption of compounded weight-loss pens had surged and that part of the market did not meet sanitary standards. The regulator had also told the press that inspections were rising and had already surpassed the total for the previous year in this category of pharmacy.
Parallel Market
Compounded weight-loss pens are not illegal in Brazil, but Anvisa's current understanding is that pharmacies may prepare them only for individualized prescriptions. The agency says pharmacies cannot even keep stock of the products.
In April, Anvisa said at least 100 kg of tirzepatide, the active ingredient in Mounjaro, had been imported in roughly six months for use by compounding pharmacies. The agency said that volume would be enough to make about 20 million 5 mg pens.
The following month, Anvisa and the Federal Police said in a joint note that the volume was incompatible with the legal market and indicated failures in the regulatory control chain and increased sanitary risk. They said the situation showed signs typical of complex organized crime, including the misuse of apparently regular structures such as compounding pharmacies, clinics and shell companies to hide clandestine industrial activity.
The pharmacies operate alongside the market for Anvisa-registered medicines sold under brands such as Ozempic, Ozivy and Mounjaro. Folha says compounded pens are also often sold directly by medical clinics as part of weight-loss protocols.
Medical associations and Sindusfarma, which represents major pharmaceutical companies in Brazil, have argued for a full ban on compounded weight-loss drugs. Pharmacy representatives say the businesses meet technical requirements and argue that restrictions would strengthen the market for fake or illegally imported products, including items from Paraguay.
Anvisa is also preparing a broader overhaul of rules for sterile compounding pharmacies. It authorized 77 such pharmacies in 2024, 265 in 2025 and 186 in 2026 through July. The regulator says it does not have consolidated data on how many produce weight-loss pens.