Written By Rohan Kumar / Laboratory Analyst 1
Author Note: The USP governs and directs many of the required test procedures in use by FDA regulated industries such as Pharma, Biotechnology and Medical Device. This article is intended to provide a history and outline the impact the USP has on industry especially when it comes to patient safety.
The United States Pharmacopeia, or USP, is an organization with a rich history spanning over 200 years. Their contributions have had profound impacts on the history of medicine not just in the US but across the globe, helping ensure the quality, purity, strength, and consistency of healthcare products. The USP was first founded with the intent to protect patients from being harmed by the poorly created medications that were supposed to help them. Now, the USP functions as an independent, scientific organization, helping set standards for public health, facilitate pharmaceutical advancements, and supports regulatory organizations.
Prior to the establishment of the USP, the quality and consistency of medicine produced in the United States was quite poor, varying greatly from pharmacy to pharmacy and even between batches. A lack of standardized guidelines resulted in the inconsistency and unreliability of medical treatments. With the goal of improving the status quo, eleven physicians gathered in the early 1800s to recognize this problem and develop a solution.
December 15, 1820, saw the first edition of the United States Pharmacopeia published in Washington, D.C. This marked a turning point in public health as a significant step had been taken towards ensuring that commonly used medicines were consistently produced across the country. This would help develop patients’ trust in the quality of the products they purchased. Throughout the course of the 19th century, the USP would undergo further revisions to further develop its standards.
One of the most significant moments in the history of the USP was the passage of the Pure Food and Drug Act of 1906 which took the USP beyond its role as a compendia of healthcare products. With the passage of the Pure Food and Drug Act, the USP was recognized as an official pharmacopeia and drugs would be required to meet USP standards. Failure to meet USP standards would put companies at risk of being shut down and facing legal repercussions if adulterated or misbranded drugs were being sold. This marked a monumental shift not only in the USP as their standards would now be legally enforced by a government body, the Food and Drug Administration (FDA).
The 1910-1960s saw significant advancements and growth in the pharmaceutical industry. Antibiotics like penicillin, vaccines, and biologics like insulin would revolutionize the world and fundamentally change the way humanity interacted with diseases. During this period, the USP would expand its compendium to include chapters pertaining to new types of treatments as well as include analytical techniques to assess the products.
The late 1990s would see the USP further develop and evolve into its current role. More sophisticated methods such as chromatography and spectroscopy would be adopted by the USP in response to advancements in chemistry and drug manufacturing, allowing for more precise assessments of drug purity and potency. This era would also see an increasing global influence of the USP. Organizations such as the World Health Organization (WHO) and International Council for Harmonization (ICH) further reinforced the need for the global consistency of drug quality standards and would help facilitate communication between the USP and other nations’ organizations to ensure healthcare safety globally.
Recently, the USP has expanded their regulations and information in trending areas such as biologics, gene therapies, and advanced manufacturing technologies. Personalized medicine and biotechnology are key drivers, pushing organizations like the USP to develop new standards, ensuring that every aspect of a product is produced in a safe and reliable manner.
Currently, the USP has over 330 chapters from gene therapy products to plastic packaging systems and over 2600 monographs for drugs. As a contract lab serving the packaging needs of the life sciences industry, the USP plays a key role in defining many of CS Analytical’s service offerings. Chapters such as USP 381, 661, 1207, and many more, outline and recommend testing for package systems and components to ensure that they meet the necessary specifications, ensuring the safety and efficacy of the product they are protecting. Ensuring that packaging can perform as intended throughout the product lifecycle is critical to maintaining the safety, sterility, and effectiveness of any healthcare item.
As the organizations look into the future, some of the goals of the USP address key disruptors in the healthcare space. Advancements in digital healthcare, an increasingly globalized supply chain that can be unevenly regulated, and new manufacturing technologies all pose challenges to the current system. The USP is committed to understanding and building a thorough regulatory framework around new technological developments.
From its simple beginnings as an eleven-person operation in 1820 to its current role as a global authority in drug quality and safety, the USP has maintained a strong commitment to their goal in protecting and improving public health. As new advancements and challenges in the healthcare industry emerge, the USP will continue to play a crucial role in ensuring the quality and reliability of medicines for years to come.