Regulatory Compliance Among Private Pharmaceutical Outlets in Three Regions of Tanzania
DOI:
https://doi.org/10.66531/mjph.2026.v1i2.e8Keywords:
Regulatory Compliance, Pharmacies, ADDOs, Pharmaceutical Outlets, TanzaniaAbstract
Background: Regulatory compliance within pharmaceutical outlets is essential to ensure that medicines distributed to the public meet established standards of quality, safety, and efficacy. Private pharmaceutical outlets play a significant role in the distribution of medicines and healthcare delivery. This study aimed to assess regulatory compliance among private pharmaceutical outlets in three regions of Tanzania.
Materials and Methods: A retrospective cross-sectional study was conducted in May 2025 using secondary data extracted from inspection forms completed by the Pharmacy Council of Tanzania during routine regulatory inspections carried out between January and December 2024 in Dar es Salaam, Dodoma, and Mwanza. A multi-stage sampling approach was employed. An outlet was considered compliant if it met at least 10 out of the 12 selected regulatory compliance criteria.
Results: A total of 734 pharmaceutical outlets were assessed. Among these, 54.6% were ADDOs and 45.4% were pharmacies. Overall, 165 (22.5%) were reported to be compliant with the regulatory requirements. The highest compliance was observed in adequate lighting and ventilation 650 (88.6%). Other parameters compliance levels were: valid business permits 320 (43.6%), presence of expired medicines on the shelf (39.6%) of outlets, and presence of unregistered health products (30.4%). Pharmacies demonstrated significantly higher (28.5% vs 17.5%) overall regulatory compliance compared to ADDOs (OR = 1.89; CI: 1.32–2.68, p<0.001).
Conclusion: The regulatory compliance among private pharmaceutical outlets remains suboptimal. Pharmacies exhibited higher compliance compared to ADDOs. Strengthening regulatory enforcement, enhancing routine inspections, and providing continuous professional development are essential to improving compliance.
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Copyright (c) 2026 Stanley Mwita, Godfrey Ngonela, Deogratias Katabalo, Pascalia Nyoni, Samwel Zakayo, Joseph Mwasambili, Cosmas Kayombo, Grace Maina, Elmer Emmanuel, Vannesa Stephen, Boniface Magige (Author)
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