Hundreds of pharmacies operating in the country have clearly regulated conditions for the provision of services to the population and comply with specific standards dictated by the relevant legislation. With consumers free to access most drugs, control over pharmacy operations is an essential aspect of policies that are developed to maintain the national healthcare safety. As specific measures to address the issue, individual rules and laws are intended to coordinate the operation of pharmacies and promote a service delivery regime based on the existing regulations. This paper aims to compare two laws related to the operation of pharmacies – the Drug Supply Chain Security Act (DSCSA) and the Texas Pharmacy Act. These regulations are federal and state laws, respectively, and are intended to coordinate the activities of pharmacies, but some of their provisions differ, in particular, the scope.
Scope of the Laws
When comparing the scope that both laws under consideration cover, one can note that each of them aims to implement specific rules at different levels. According to the U.S. Food and Drug Administration (2019), the DSCSA is a federal law, and within its scope, pharmacies are included in the national context. This act was ratified in 2013, and its key purpose is to monitor the safety of drugs sold to the public, which explains the involvement of pharmacies as the main intermediaries (U.S. Food and Drug Administration, 2019). As one of the requirements for the operation of pharmacies, the DSCSA puts forward the rules according to which every outlet is to have an appropriate registration or license. Consequently, the law prohibits selling pharmaceuticals without an officially confirmed seller status. Similar conditions apply to the receipt and storage of drugs of different pharmacological groups. In addition, according to the U.S. Food and Drug Administration (2019), pharmacies must monitor the expiration date of drugs. In case of detecting counterfeit medications, investigations should be carried out by the official representatives to identify and fix the source of the problem.
The Texas Pharmacy Act has similar goals, but its key difference is the scope that applies only to Texas. The interest in the professional activities of pharmaceutical outlets is due to the need to ensure the safety of the population at the state level and monitor citizens’ welfare (Texas State Board of Pharmacy, 2014). At the same time, unlike the DSCSA, the Texas Act is more detailed as a regulatory project that defines the range of stakeholders’ responsibilities. In particular, this scope includes the duties of administrators and employees, the work of insurance authorities, and other aspects (Texas State Board of Pharmacy, 2014). Licensing principles are also mentioned, and the nuances of obtaining the official permission to sell pharmaceuticals are considered. In addition, according to the Texas State Board of Pharmacy (2014), the terms of professional responsibilities for the employees of different categories are provided, and specific penalties for violations are stated. While comparing the two laws in question, one, however, can find some similar features, in particular, the conditions of mediation imposed on pharmacies both at the federal and state levels.
Mediation Features
Both the DSCSA and the Texas Pharmacy Act provide for assessing the role of pharmacies as intermediaries in the sale of pharmaceuticals to the public. According to the U.S. Food and Drug Administration (2019), pharmacies are to follow the terms of safe trade, which is to control the quality of drugs and the conditions for their storage. The Texas Act also includes this clause, and individual administrative inspections are referred to as monitoring measures (Texas State Board of Pharmacy, 2014). One of the main features in both laws is the definition of licensing standards for pharmacies. Nevertheless, in these rules, there are some distinctive features to mention. For instance, in Texas, registration is a sufficient procedure for the legalization of pharmacy employees’ activities, while in many other states, licensure coordinated by the federal authorities is required (Texas State Board of Pharmacy, 2014). However, this aspect influences the work of pharmacies insignificantly and can be presented as a minor difference.
Given the similarity of the two laws in the context of the mediating role of pharmacies, one can assume that both acts perform similar functions. At the same time, the DSCSA is a broader regulatory act in which the oversight of pharmacy operations is one of the topics. The Texas Pharmacy Act, in turn, focuses only on this aspect of the healthcare system and citizens’ well-being. As a result, the federal code of laws proposes general provisions, and the state act is aimed at specific conditions for organizing the work of pharmacies and related nuances – stakeholder liability, employment, and other topics. Thus, the scope is the most evident criterion that distinguishes the laws in question.
Conclusion
As the reviewed pharmacy laws for comparison, the DSCSA and the Texas Pharmacy Act are presented, and despite the similarities in the topic they address, the scope is an essential criterion that distinguishes both acts. In terms of defining the mediating role of pharmacies, these regulations are similar as they emphasize responsibilities to the public and inspection boards. At the same time, the DSCSA is a broader law covering different areas, while the Texas Act addresses only the activities of pharmacies at the state level.
References
Texas State Board of Pharmacy. (2014). Texas Pharmacy Act. Web.
U.S. Food and Drug Administration. (2019). Pharmacists: Utilize DSCSA requirements to protect your patients. Web.