Retail Pharmacies Business Guide
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All 41 Documented Cases
Penalidades por Não-Conformidade ao SNGPC (Portaria 344/1998)
LOGIC-based estimate: Typical ANVISA administrative fines for non-compliance range R$ 5,000–R$ 50,000 per violation; larger networks face R$ 100,000+ for systemic SNGPC failures. Operational costs from license suspensions or revocation: loss of controlled-substance revenue (15–30% of pharmacy revenue), estimated R$ 50,000–R$ 500,000+ per pharmacy per month during suspension.Pharmacies face fines for incomplete or delayed SNGPC reporting, failure to maintain required records for controlled substances, and discrepancies between physical inventory and SNGPC declarations. Responsibilities include maintaining updated ANVISA registration, correct registration of all movements, and accurate retention of medical prescriptions (Portaria 344/1998, Art. 37-42).
Multa por Violação de Competência Profissional e Risco de Revogação de Alvarás
Estimated R$ 50,000-200,000 per pharmacy location in compliance remediation, system reversion, and staff retraining. Plus exposure to administrative fines (Lei 6.437/77) for operating without proper competency authorization.Federal Court in Brasília (TRF-1) suspended CFF Resolution 5/2025 on March 31, 2025, ruling that pharmacists lack legal competency and technical preparation for diagnosis and prescription. The CFM successfully argued that Law 12.842/2013 reserves diagnostic and prescription acts as exclusive medical functions. Pharmacies operating under the suspended resolution face legal challenge and potential license revocation.
Erros de Decisão por Falta de Visibilidade em Tempo Real sobre Estoque de Medicamentos Controlados
LOGIC-based estimate: 2–5% inventory waste (expiration/spoilage) on R$ 100,000/month controlled-substance revenue = R$ 2,000–R$ 5,000/month. 5–10% stock-out-driven lost sales = R$ 5,000–R$ 10,000/month forgone margin. Combined: R$ 7,000–R$ 15,000/month per pharmacy. Network (50 locations): R$ 350,000–R$ 750,000/month. Annual: R$ 4.2M–R$ 9M.Controlled substances are high-value, regulated, and have strict shelf-life requirements. Poor inventory visibility leads to: (1) over-purchasing due to perceived low stock → expiration waste; (2) under-purchasing due to delayed reporting → stock-outs, lost sales, customer churn to competitors; (3) inability to optimize by-prescriber demand (e.g., surge in antidepressants in winter).
Perda por Vencimento de Medicamentos (Product Expiration Waste)
Estimated: R$ 2,000–25,000 annually per pharmacy (2–5% of typical inventory value of R$ 100,000–500,000). Pharmacy chains with 10+ locations: R$ 20,000–250,000+ annually.Pharmacies in Brazil operating without automated inventory systems experience preventable waste from expired medications. Sources [1], [3], [4] emphasize FIFO/PEPS methodology and periodic inventories to prevent this, indicating it is a widespread pain point. When manual processes fail, products approach expiration without being prioritized for sale.