Knoben J E, Scott G R, Tonelli R J
Division of Drug Information Resources (DDIR), Food and Drug Administration.
Am J Hosp Pharm. 1990 Dec;47(12):2696-700.
The history, purpose, and content of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") are described. When cost guidelines established in the 1970s for Medicare reimbursement prompted most states to permit generic drug product selection, an official list of interchangeable drug products was needed. Regulations for determining bioavailability and bioequivalence were published in 1977, and FDA first published Approved Drug Products in 1980. The Orange Book includes products that have been fully reviewed by FDA for both safety and effectiveness and for which new drug applications (NDAs) or abbreviated new drug applications (ANDAs) and special applications (From 5s or 6s) for antibiotics have been approved. Pursuant to the 1984 Drug Price Competition and Patent Term Restoration Act, FDA added approved nonprescription products to the Orange Book along with information about patents and periods of marketing exclusivity. Orphan drug products and certain testing and application procedures are also provided. Equivalence evaluations are provided in the Orange Book only for multisource prescription drug products that contain the same active ingredients and can be expected to have the same clinical effect when administered to patients under the conditions specified in the labeling. A coding system is used to indicate the products' equivalence evaluations according to FDA criteria, and indexes by product name and manufacturer are included. Monthly Cumulative Supplements are issued. The Orange Book contains public information and advice, but it is not an official national compendium; FDA has no position on state regulation of drug product selection by pharmacists. The equivalence evaluations do not relieve practitioners from exercising care in prescribing and dispensing products according to patients' individual needs.
描述了美国食品药品监督管理局（FDA）的《已批准治疗等效性评价药品（橙皮书）》的历史、目的和内容。20世纪70年代制定的医疗保险报销成本指南促使大多数州允许选择通用药品，因此需要一份可互换药品的官方清单。1977年发布了确定生物利用度和生物等效性的法规，FDA于1980年首次发布《已批准药品》。橙皮书包括已由FDA全面审查其安全性和有效性、且新药申请（NDAs）或简略新药申请（ANDAs）以及抗生素特殊申请（5类或6类）已获批准的产品。根据1984年《药品价格竞争和专利期限恢复法案》，FDA将已批准的非处方产品以及专利和市场独占期信息添加到橙皮书中。还提供了孤儿药品和某些测试及申请程序。橙皮书中仅对含有相同活性成分、且在标签规定条件下给患者用药时预期具有相同临床效果的多源处方药产品进行等效性评价。使用一种编码系统根据FDA标准指示产品的等效性评价，并包含按产品名称和制造商编制的索引。每月发布累积增补本。橙皮书包含公共信息和建议，但它不是官方的国家汇编；FDA对药剂师选择药品的州监管没有立场。等效性评价并不能免除从业者根据患者个体需求谨慎开处方和配药的责任。
