USP- United States Pharmacopoeia

Brief profile:

A pharmacopeia is a compendium or collection of drug information. The USP is one such pharmacopeia that is published by the United States annually. The trademark and copyrights of the United States Pharmacopoeia are owned by a nonprofit organization called Pharmacopoeial Convention ( also called USP ). The first edition of USP was published in 1820, and around 43 editions have been published since then. The latest version of the USP was published in 2019.

Responsibilities or scope:

  • It is responsible for building trust in the supply of safe and quality medicines.
  • It also establishes written and physical reference standards for medicines, food ingredients, supplementary dietary products, and other ingredients.
  • The USP is often published in a combined volume with a National Formulary as the USP – NF. 
  • The standards of both human and animal drugs are specified in the USP, and these have a role in the US federal law.
  • It only lays the compendial standards for strength, quality, and purity of the drug or ingredient but has no role in enforcing its standards. Enforcement of these standards is the responsibility of the USFDA and other government agencies of the United States.

Importance of United States Pharmacopoeia

  • Any drug ingredient that does not conform to the standards laid out by the USP is considered contaminated and not often accepted by the USFDA for human or animal use. 
  • Regulatory agencies and other manufacturers generally use the standards to ensure that the product is of appropriate identity, strength, purity, quality, and consistency.
  • All the prescription and non – prescription drugs sold in the US must meet the – NF public standards. 
  • The quality and purity of food ingredients like preservatives, flavoring, colorings, and nutrients are established by the Foods Chemical Codex standards (FCC ). The FCC is a part of the USP’s standards for food ingredients.
  • Dietary supplement products with the label “USP Verified products” have been specially tested. These products are different from those with the label “USP“alone, which adhere to the USP standards as claimed by the manufacturer.
  • The USP has also cooperated with the United States Agency for International Development ( USAID ) to help developing countries address critical issues related to poor quality medicines in over 35 countries. 2

Other relevant information :

  • The USP: NF contains more than 4500 monographs for prescription and over–the–counter products, dietary supplements, and other healthcare products. 1
  • The United States Pharmacopoeia is printed in three volumes. The first volume contains general chapters, while the second and third contain monographs.
  • Over 14 appendices are generally present in the USP. These contain information related to the apparatus used for tests and assays, physical and chemical tests, enzyme assays, microbiological tests, contaminants in food, flavor chemicals, and markers for authenticity testing.
  • International regulatory agencies and lawmaking bodies in over 140 countries use the USP – NF standards to ensure the quality of the medicines produced or exported to their countries.

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