Welcome to our new home!

Enquire Now

Call us today on 0333 939 0034

Put the kettle on.

Close

How can we help make your day better?

    United States Pharmacopeia (USP)

    United States Pharmacopeia, a drug regulating agency.

    PTL Boffins - Job Role

    The United States Pharmacopeia (USP) is a non-profit organisation that establishes and publishes quality standards for the identity, strength, quality, and purity of medicines, dietary supplements, and healthcare products in the United States. These standards are widely recognized and used not only in the United States but also around the world to ensure the safety and efficacy of pharmaceuticals and related products.

    Key features of USP:

    Here are some key points about the United States Pharmacopeia:

    History

    The organisation has a long history dating back to the early 19th century when it was founded as a private organization. Over the years, it has evolved into a globally recognized authority on pharmaceutical quality standards.

    Standards Development

    The United States Pharmacopeia develops and maintains a collection of standards known as the United States Pharmacopeia-National Formulary (USP-NF). The USP-NF compendium contains monographs, which are detailed specifications for individual drugs and ingredients, as well as general chapters that cover various aspects of pharmaceutical quality.

    Monographs

    A USP monograph includes information on the drug’s identity, strength, quality, purity, packaging, and labelling requirements. These monographs serve as the official reference standards for specific drugs or substances.

    USP-NF

    The USP-NF is published as a combined compendium, with USP containing drug monographs and general chapters on drug quality, and National Formulary (NF), containing monographs on excipients, dietary supplements, and other non-drug substances. These standards are legally enforceable in the United States.

    Global Impact

    While USP standards are primarily used in the United States, they are also adopted and recognized by many other countries and international organizations. These standards are used to harmonize and ensure the quality of pharmaceutical products worldwide.

    Public Health Focus

    The organisation’s mission is to improve global health by promoting the quality and safety of medicines and healthcare products. It works in collaboration with various stakeholders, including regulatory agencies, healthcare professionals, and industry partners, to achieve this goal.

    Pharmacopeial Forum

    The organisation publishes the Pharmacopeial Forum, a bimonthly online publication that provides proposed revisions to USP-NF standards, allowing stakeholders to review and comment on proposed changes before they are finalized.

    Compliance and Verification

    Pharmaceutical manufacturers are required to comply with their standards and may undergo verification and inspection processes to ensure compliance. Compliance with United States Pharmacopeia standards is often a regulatory requirement for drug approval and marketing in the United States.

    USP Verification Programs

    The United States Pharmacopeia offers verification programs for dietary supplements, which allow manufacturers to voluntarily submit their products for testing and verification of compliance with USP standards.

    The role of USP

    The United States Pharmacopeia plays a critical role in ensuring the quality, safety, and efficacy of pharmaceuticals and healthcare products in the United States and beyond. Its standards provide a foundation for quality assurance and regulatory compliance in the pharmaceutical industry, contributing to public health and patient safety.

    Join our inbox fan club

    We’ll update you on gasket stuff. It’ll change your life, honestly!

    PTL / News

    Pure Transfer curve