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USP and Pharmacists

USP has been supporting the critical role that pharmacists play in promoting the public health for close to 200 years. Since its inception, USP has established quality standards for drug products that pharmacists prepare and compound. Medicines may be compounded (prepared from ingredients, or mixed together) to meet the needs of a specific patient, or to provide access to a drug that has gone off the market or is otherwise unavailable. Today, USP continues to provide official standards of quality for medicines. These standards allow pharmacists to treat their patients with confidence. And when a patient requires an individualized therapy not available commercially, USP has provided officially recognized compounding formulations and practice standards that pharmacists can rely on.


USP depends on the expertise of pharmacists through their participation and membership on USP's governing and scientific decision-making bodies, including the Board of Trustees, Council of Experts, and USP Convention. Their perspectives are essential to USP's work, as pharmacists may be the final link in the safe delivery of medication to patients and they play a primary role in educating patients on the safe use of their medications.

Medicines

USP sets scientifically developed standards that help ensure the identity, quality, purity, strength, and consistency of medicines. These standards—which are enforceable by the U.S. Food and Drug Administration (FDA) and used in more than 130 countries—are published in the United States Pharmacopeia–National Formulary (USP–NF), which have been relied upon by pharmacists for almost two centuries.

Beyond standards for specific drugs and ingredients, the USP–NF include other standards designed for pharmacists covering key topics such as maintaining a physical environment in their pharmacies that promotes safe medication use, quality assurance in compounding, and sterile compounding practices. Some of these standards are legally enforceable, while others are informational and designed to help pharmacists deliver good pharmaceutical care to patients. This work is done under the purview of USP Expert Committees. More information about the committees and their work is available here.

Compounding in Pharmacies

USP is a founding member of the Pharmacy Compounding Accreditation Board (PCAB), which is committed to uniform accreditation standards for the compounding profession. USP especially recognizes and supports the increased need for pharmacy compounding over the last two decades, because of the limited availability of dosage forms (e.g., capsules, elixirs, injections, ointments) when new drugs are introduced into the market. USP's official standards for pharmacy compounding of sterile and nonsterile preparations and other pharmacy practices are available through the USP–NF as well as the Pharmacists' Pharmacopeia, USP's dedicated reference for pharmacists, veterinarians, other health professionals and students.

Your responsibility under the law...

Practitioners who compound should understand their responsibility to comply with standards in the USP. Simply said, compounded preparations must meet official USP–NF standards (found in the USP–NF as well as the Pharmacists' Pharmacopeia), including ingredient standards and the "recipe" for the preparation. It is widely understood that key requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) apply equally to drugs that are compounded and those that are manufactured. For compounding practitioners, that means drugs sold in the United States that are recognized in official compendia (including USP–NF) must adhere to those standards for identity, quality, purity, and strength, a well as packaging and labeling.

Thus, while the FDA generally defers to the states to regulate the practice of health professions, it takes a keen interest in the quality and safety of the compounded preparations that reach patients. The FDA will act in concert with the states in investigating allegations of poor quality compounded drugs, but it has also demonstrated a willingness under the FFDCA to act on its own initiative. If a state is unwilling or unable to join the Agency's efforts, the FDA may act unilaterally to protect the public health from compounded drugs that pose unreasonable risks.

Sterile Compounding

The USP Sterile Compounding Expert Committee (SCC) has completed the review and revision of General Chapter <797>. The revised chapter was posted on USP's Web site as a Revision Bulletin to allow practitioners the opportunity to review and assimilate the content of the chapter before it became official on June 1, 2008.

Medication Error Prevention

In addition to producing several standards that help to prevent medication errors in pharmacies—for example, those that describe how to maintain a physical environment that promotes safe medication use—USP works with leading pharmacy groups in a collaborative effort to help prevent such errors. The organization is a founding member and secretariat for the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). NCC MERP is an independent body comprising 26 national healthcare organizations, including the American Pharmacists Association, the American Society of Consultant Pharmacists, and the American Society of Health-System Pharmacists, which are collaborating to address the interdisciplinary causes of errors and to promote the safe use of medications. For more information about this group and its work, visit www.nccmerp.org.

Dietary Supplement Information

Patients look to their pharmacists as important advisors in their medical care. Patient counseling by pharmacists may include not only answering questions about prescription medications but also over-the-counter drugs and dietary supplements. Because dietary supplements are regulated in the United States under the food provisions of the FFDCA and not according to the same guidelines as the medicines, identifying high-quality supplements to recommend to patients can be a challenge. Dietary supplements are only subject to USP standards when they are labeled as such. To help healthcare professionals and consumers identify quality supplements, USP operates a separate "verification" program for dietary supplements. Manufacturers can voluntarily submit their products to testing by USP, and dietary supplements that meet the program's strict criteria are awarded the USP Verified Mark (pictured above). This indicates that the product contains the ingredients listed on the label, in the declared potency and amounts; does not contain harmful levels of specified contaminants; will break down and release into the body in a specified amount of time; and has been made according to the FDA's Good Manufacturing Processes. It also allows pharmacists to confidently recommend supplements to consumers—important whether a patient relies on supplements to generally enhance health, or to meet a specific dietary need based on a vitamin deficiency or situation such as pregnancy. For more information on the program, click here .

USP Information Resources