USP: The Silent Sentinel

October 15, 2014

One major reason why the United States has few concerns about the supply chain is the role of the US Pharmacopeial Convention.

Have you ever worried about whether the medication you are giving to a patient or taking yourself consists of no drug, the incorrect amount, or an entirely different drug? I would guess that most of us in the United States have never given this a second thought. For those of you who live in an area without a robust supply chain, however, chances are that it is frequently considered. Why is there such a difference in experiences?

One major reason why the United States has few concerns about the supply chain is the role of the US Pharmacopeial Convention (USP). Most pharmacists are familiar with the USP because of its regulations that guide sterile and nonsterile preparations in USP <795> and <797>. While that is one area of focus for USP, the organization does much more to ensure the supply chain is intact and that we do not have to worry about adulterated and counterfeit medications.

The history of the USP goes all the way back to 1820. Eleven individuals gathered to develop a national formulary, and their work established the original USP compendium. In 1848, federal legislation was passed that recognized the USP as an official compendium.

Within that law, the following statements can be found:

  • A drug/biologic “shall” be deemed adulterated “if it purports to be or is represented as a drug the name of which is recognized in an official compendium [current version of USP or National Formulary deemed official by USP], and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium.” {FDCA 501(b)}
  • A drug/biologic “shall” be deemed misbranded “if it purports to be a drug the name of which is recognized in [USP-NF].” {FDCA 502(g)}

One important thing to note regarding the USP is it is not involved in enforcement of the law, because that task is left to the FDA. However, the FDA’s enforcement is based upon the US law, which recognizes the USP as the official compendium. Thus, it has a very influential position by setting standards to ensure the supply chain is intact and that all medications are deemed safe to use.

As health care professionals, it is important to recognize why we do not worry about adulterated and misbranded medications in the supply chain. Understanding what safety standards are in place and who develops and enforces them is critical to this knowledge. This will lead to a better understanding of the purpose and role of the USP. Further investigation will highlight that the organization works to ensure appropriate reference standards and drug monographs for biologics, dietary supplements, OTC medications, and natural products.

On a larger scale, the USP also plays a major role in protecting the global supply of pharmaceutical products. It is actually engaging with other pharmacopeias around the world to harmonize drug monographs. More than 40 countries have adopted the USP as the official monographs, thus ensuring that the reference standards for drugs are uniform. These steps are extremely important as we realize the global connectedness of the entire pharmaceutical supply chain.

If learning about the important work that is involved within the USP interests you, then I would encourage you to submit your name to join a committee. The USP is truly a volunteer organization, and everyone involved is committed to making medications safe for every individual who uses them.

The volunteers encompass practitioners, academics, and industry representatives. I have been involved with the USP, attending the last 3 conventions as a representative of my state pharmacy association. I have truly enjoyed learning about the organization and meeting new people, and I look forward to contributing more significantly in the future. There is currently an ongoing call for volunteers for the USP expert committees. More information on the different committees, expectations, and how to apply can be found at www.usp.org. I hope you will consider giving back to an organization that has given so much to our profession.

I refer to the USP as “the silent sentinel” because it is standing guard to ensure that all medications used in the United States are safe for the patient.

I would appreciate any insights you might have on this perspective. You can let me know what you think by emailing me at seckel@unc.edu.