Abstract
Background and Aim: Community pharmacies are increasingly recognized as key access points for primary healthcare, particularly in resource-limited settings. Integrating point-of-care (POC) diagnostic services into these pharmacies can enhance early disease detection and patient management. However, regulatory frameworks guiding such integration remain fragmented or underdeveloped. This scoping review synthesized global evidence on regulatory policies and guidelines governing the implementation of POC diagnostic services in community pharmacy settings to inform regulatory and policy development in South Africa. Methods: The Arksey and O'Malley framework and Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews (PRISMA-ScR) reporting standards were followed. A comprehensive search was conducted across PubMed, EBSCOhost, Scopus, Web of Science, and ProQuest. Eligible peer-reviewed and gray literature discussed policies or frameworks regulating pharmacy-based POC diagnostic services. Data were extracted and thematically analyzed to identify regulatory trends, enablers, and barriers. Methodological quality was assessed using the Mixed Methods Appraisal Tool 2018 and Scale for the Assessment of Narrative Review Articles (SANRAs). Results: A total of 5780 records were screened, and six studies met the inclusion criteria. Most originated from high-income countries such as the United States and Canada, where frameworks like the Clinical Laboratory Improvement Amendments (CLIA) waivers and collaborative practice agreements (CPAs) support pharmacy involvement in diagnostics. Four themes emerged: (1) regulatory frameworks, (2) training and competency, (3) implementation challenges, and (4) public health opportunities. No policy governing pharmacy–based POC diagnostics exists in South Africa. Conclusion: Regulatory structures for pharmacy-based POC diagnostics remain inconsistent globally and absent in South Africa, informing the need for context-specific policy, structured training, and sustainable reimbursement mechanisms.