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Original Contribution

Making Sense of “Official” Drugs

December 2004

Official drugs in the United States are listed in the United States Pharmacopeia (USP) or the National Formulary (NF).1 Official homeopathic compounds are found in the Homeopathic Pharmacopeia (HPUS).2 Many EMS professionals can learn more about the role of the USP, NF or the HPUS in the regulation of drugs and supplements in the United States to better assess and treat patients in the prehospital setting.

Official Sources of Drug Information

The United States Pharmacopeial Convention, Inc., a nongovernment, not-for-profit organization, is producer of the USP-NF publications. The organization promotes public health through standards to ensure the quality of medicines and other healthcare technologies. It has become the companion nongovernmental organization to the U.S. Food and Drug Administration (FDA).

These standards are published under one cover in the United States Pharmacopeia and the National Formulary (USP-NF). This publication is officially recognized in the federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321 et seq.) as the source of drug standards. In 2001, the USP additionally developed the Dietary Supplement Verification Program (DSVP) in response to increasing concerns about the quality of dietary supplements in the marketplace.3

The Homeopathic Pharmacopeia (HPUS) is published on authority of The Pharmacopeia Convention of the American Institute of Homeopathy.4 EMS providers wanting additional information on the homeopathic pharmacopeia should visit www.hpus.com. Any substance can be considered a homeopathic medicine if it has known “homeopathic provings” and/or known effects that improve the symptoms, syndromes or conditions that it is administered to treat, and is manufactured according to the specifications of the HPUS.5

History and Function of the USP Organization

The USP was established in the United States in 1820.6 Since 1820, USP has established standards for more than 4,000 prescription, over-the-counter medicines and dietary supplements.7 The USP also has developed monograph standards for more than 900 nutritional and dietary supplement products. When the USP was formed in the early 19th century, there was a growing need for scientific information about new medicines that were becoming available in the United States. For example, many new plants were discovered and were being used to produce drug components for patient treatment. Until publication of the first USP, there was no standard information regarding which part of the plant to use, for example, or any information on the correct procedure to prepare the material for drug use. The first edition of the USP mainly focused on drugs of plant origin, many of which were native to the United States. Until 1940, the USP was revised every 10 years. Then, until 2000, new revisions to the USP were published every five years. Now, the USP-NF is revised every year.

The current official edition is the USP 26-NF 21—the 26th edition of the USP and the 21st edition of the National Formulary.8 The National Formulary, established in 1888 by the American Pharmaceutical Assoc-iation, includes standards for excipients, botanicals and other similar products. USP purchased the NF in 1975, combining the two publications under one cover to create the USP-NF.

The USP is also responsible for setting the overall national and international standards for the constituents used in drug manufacturing. These constituents are called the excipients.

In addition, the USP produces specific drug monographs, which are widely available and are published in the yearly USP-National Formulary (NF) edition. The USP-NF contains more than 3,400 monographs for drug substances and products and more than 160 general chapters describing specific procedures that support the monograph tests and other information.

The USP works with the FDA on all regulatory aspects of drugs and medications, and also works closely with various countries, including India, Japan, Brazil, Argentina and Canada. This cooperation provides for a more universal collection of drug and compound information for physicians and consumers.

Publication Legal Status

A “USP” insignia on an official drug name or container indicates that the manufacturer claims that certain ingredients contained in the product have an FDA-approved or USP-accepted use, have been used extensively without a significant safety risk, and meet the quality standards published in the United States Pharmacopeia.9 These standards specify allowable rates of disintegration and dissolution, strength (range of dosage variance), range of acceptable impurities and existence of an expiration date. An “NF” insignia indicates that the manufacturer is claiming that ingredients contained in the product have been used extensively without a significant safety risk and meet the quality standards published in the United States Pharmacopeia National Formulary. These standards specify allowable rates of disintegration and dissolution, strength (range of dosage variance), range of acceptable impurities and existence of an expiration date. Unlike the USP insignia, NF products are not required to have an FDA-approved or USP-accepted use.

Summary

The USP-NF and the HPUS are the recognized official references for drugs, supplements and homeopathic compounds produced in the United States. EMS providers can learn much about how the substances patients ingest can affect body systems and how they interact through researching the USP-NF and the HPUS.

References

1. Sanders MJ. Mosby’s Paramedic Textbook, Ed. 2 Rev. St Louis, MO: Mosby Lifeline, 2001.
2. www.usp.org.
3. www.usp.org.
4. wwwhpus.com.
5. www.homeopathicdoctor.com/page8.html.
6. www.rheuma21st.com/archives/report_hess_usp_exc_meeting.html.
7. www.fda.gov/ora/science_ref/lpm/lpchter6.html.
8. www.usp.org.
9. www.supplementquality.com/label/certification.html.

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