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Abstract
The United States Pharmacopeial Convention, a nongovernmental, nonprofit standards-setting organization, is active in the development of standards and information for many therapeutic ingredients and products, including compounded preparations utilized in human and veterinary health care. These activities are spearheaded by several expert committees, including Compounding Pharmacy, Sterile Compounding, Veterinary Drugs, and Veterinary Medicine Information, with assistance from associated staff scientists. This article highlights the key processes surrounding the development of United States Pharmacopeial Convention standard formulations and clinical use information for compounded medications used in veterinary medicine.
The mission of the United States Pharmacopeial Convention (USP) is promotion of public health through dissemination of authoritative standards and information developed by its volunteers for medicines, other healthcare technologies, and related practices used to maintain and improve health and to promote optimal healthcare delivery.1 USP was founded in 1820 by the medical community to standardize formulations. At diat time, drugs prescribed by a physician typically were compounded by local pharmacists. The first Pharmacopeia of the United States of America, published in December 1820, contained monographs for 217 commonly used medications; the monographs were intended as recipes for pharmacists to follow in preparing these drugs. Ingredients used to prepare drug products were derived exclusively from natural plant, animal, or mineral sources. Drugs included in the first pharmacopeia were selected "...from among substances which possess medicinal power, those, the utility of which is most fully established and best understood [so that pharmacists could] form from them preparations and compositions, in which dieir powers may be exerted to die greatest advantage."2 By this statement, the founders of USP declared diat healthcare practitioners should use standardized medications whose safety and efficacy were established.
Pharmaceutical "manufacturing" from natural ingredients continued to be performed exclusively by local pharmacists until the late 1800s, when mass production of pharmaceuticals and the manufacture of pure and synthetic drugs began. The United States Pharmacopeia (USP), which was revised and published periodically, started to incorporate standards for pure and synthetic drugs during these early times. As the pharmaceutical industry expanded, the purpose of the USP changed from setting standards for pharmacists to setting standards for the industry. Compounding formulations in the USP slowly gave way to monographs on manufacturing formulations that used bulk drug substances....