The Value of U.S. Pharmacopeial Standards: A Review of the Literature

• Published in: Journal of pharmaceutical sciences Vol. 107; no. 10; pp. 2611 - 2617
• Main Authors: Heyward, James, Padula, William, Tierce, Jonothan C., Alexander, G. Caleb
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2018
• Subjects: content uniformity; Drug Development - standards; Drug Industry - standards; drug standards; excipient(s); Humans; Marketing - standards; physical characterization; Public Health - standards; United States; US Pharmacopeia (USP); United States; standards; content uniformity; physical characterization; drug standards; excipient(s); US Pharmacopeia (USP)
• ISSN: 0022-3549; 1520-6017
• DOI: 10.1016/j.xphs.2018.06.004

While there are many standard-setting health care organizations, the United States Pharmacopeial Convention's (USP) role includes the creation of documentary and physical standards for therapeutics, including chemical drugs, excipients, and biologics. Despite the ubiquity of these standards, little work has been carried out to characterize and quantify their value. We reviewed the peer-reviewed and gray literature relevant to such evaluations. The review yielded 36 articles, focused variously on accreditation and other standards in health care, the broad impact of pharmacopeial standards and evaluations of specific USP standards. We did not find any study quantifying the impact of USP or other pharmacopeial standards, but many reports have been published that suggest the utility of USP standards to drug development, quality assurance, and public health. Frequently cited areas of impact include equitably advancing the analytical capabilities of manufacturers; enabling the creation of legally enforceable naming conventions; detecting mislabeled and substandard drugs in the marketplace, especially in the context of increased globalization of drug markets; and facilitating the harmonization of diverse international drug quality standards. Our insights provide opportunities for empiric assessments of the effects of USP standards on important outcomes including their promotion of efficient drug development, market competition, drug quality, and patient safety.