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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Volume 10, Issue 3 (2021)

Review Pages: 1 - 15

Challenges in Regulating the North American Cannabisand Hemp-derived Product Market

Andrew Charrette, Najla Guthrie, James Akingbasote* and Corey J Hilmas

Prior to the introduction of the Cannabis Act of 2018, recreational use and misuse of Cannabis was a public health concern in Canada. The United States (US) and other countries have met similar challenges in regulating the Cannabis and hemp markets under a patchwork of laws. Having been an illicit substance, the recreational Cannabis market has carried negative connotations without much consideration to well-established medical marijuana programs in North America. The intention of the Cannabis Act was to provide a comprehensive framework of regulations to protect public health and safety, reduce youth access, improve quality in the supply chain, and deter the illicit market and criminal activities. The market potential for hemp, which is defined as Cannabis containing 0.3% Δ-9-tetrahydrocannabinol (Δ-9-THC) or less, prompted the US Congress and Trump Administration to pass the US Agriculture Improvement Act at the end of 2018. This act, which followed on the heels of Canada’s Cannabis Act, took hemp out of the Drug Enforcement Administration’s hands, provided for crop insurance programs, incentivized farming opportunities, and reduced regulatory risk for retailers of finished products containing hemp-based cannabidiol (CBD). While the introduction of these two landmark Acts in North America has coincided with a boom in the demand for CBD products and propelled a significant increase in the supply chain for hemp flower, there are challenges for the regulating authorities in both countries. Canada regulates CBD differently than the US because cannabinoids, including CBD, are included on the prescription drug list in Canada and therefore can only be associated with health claims as components of medications that have been granted a Drug Identification Number. While some states permit CBD in food products, the US Food and Drug Administration (FDA), which governs interstate commerce, has remained steadfast that such products are not yet legal at this time. The US Federal Trade Commission has used its authority to target manufacturers of CBD-containing food products that do not possess competent and reliable scientific evidence to substantiate marketing claims. Health Canada and US FDA are also facing the unenviable task of implementing an enforcement strategy. Fifteen hundred dietary supplement and food products are already available for sale in the US through e-commerce, and a thriving illicit market threatens to serve the demands of consumers in both countries. Canada has a great opportunity to lead by ensuring consumer confidence, demonstrating quality in cross-border supply chains, and upholding the tenets of the Cannabis Act. If FDA permits CBD in finished products through new regulations, it will foster an even playing field for all finished product CBD manufacturers and retailers. The international Cannabis/hemp trade should be an important topic of conversation in future amendments of the Canada-United States-Mexico Agreement (CUSMA) on North American Free Trade. Active enforcement strategies in the aftermath of new regulations from all North American trading partners, will be paramount to long-term market viability for the Cannabis market.

Editorial Pages: 1 - 1

Editorial Note on Bio Pharmaceutical

Harapriya Sahoo*

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Research Article Pages: 1 - 4

Public Health Facilities??? Satisfaction on Logistics Service Provided by Bahirdar Hub Pharmaceutical Fund and Supply Agency, North West Ethiopia.

Bereket Tefera* and Bekalu Kebede

Background: Logistic is the process of planning, implementing, and controlling procedures for the efficient and effective transportation and storage of goods including services, and related information from the point of origin to the point of consumption for the purpose of meeting the customer requirements. Customer satisfaction is a key measure for healthcare logistics services and it is positively related to quality of logistics service. Therefore this study aimed to assess the public health facilities satisfaction on logistics service provided by Bahirdar hub Pharmaceutical Fund and Supply Agency

Methodology: A facility based descriptive study design was employed. Two-stage sampling technique was utilized and on the first stage health facilities were selected and on the second stage respondents were selected from each selected health facilities. A total of 27 health facilities were included for this study (6 hospitals and 21 health centers). Epidata and SPSS version 20 was utilized for data entry and analysis respectively. Frequency distribution, arithmetic mean, and percentages were calculated.

Result: according to this study 64.1% of respondents reported that they were neutral while 29.7% of respondents found to be satisfied with the quality of logistics services. In addition 4.7% of the respondents stated that they are dissatisfied with the service.

Conclusion: Generally the overall perceived customer satisfaction on the quality of logistics service provided by Bahirdar PFSA hub was average, which means the overall mean score was almost similar with the mid-point of 5-liker scale.

Recommendation: This study also constructed important recommendations for Bahirdar hub Pharmaceutical Fund and Supply Agency, and researchers based on its major findings.

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