非处方药简介

Products conforming to a monograph may be marketed without FDA preapproval, while those that do not, must undergo separate review and approval through the New Drug Application (NDA) process. conforming to a monograph 是分词 短语作定语，代替定语从句，即：
非处方药各论是一种涵盖成分、剂量、 配方、标签及试验的处方集。
OTC drug monographs are continually updated to add additional ingredients and labeling as needed.
该句翻译为：
OTC 药品专论在被不断更新以便 增加附加成分和满足标签分类的 需要。
新的OTC药品（原先只能凭处方购买） 通过新药申请过程获得批准并且经过 该过程转变成了新的非处方药。
FDA’s review of OTC drugs is primarily handled by CDER’s Office of Nonprescription Products. CDER’s Office of Nonprescription Products：药品评审中心下属的非处 方药管理处
FDA：Food and Drug Administration (美国)食品于药品管理局
FDA has been evaluating the ingredients and labeling of these products as part of “The OTC Drug Review Program.” 是一个完成进行时态的句子。完成进行 时态通常表示一个开始于过去，持续到 现在，结束于将来的动作 The OTC Drug Review Program： OTC药品审核计划
制剂、各种物质的理化指标）是一种
涵盖成分、剂量、配方、标签及试验 的处方集。 本句译为：这个计划的目标是为了为
每一类的药品建立OTC药品专论。
OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, labeling, and testing. 本句对OTC drug monographs下定义 covering acceptable ingredients,
总理事会办公室
There is also an advisory committee, the “Nonprescription Drug Advisory Committee,” which meets regularly to assist the agency in evaluating issues surrounding these products.
doses, formulations, labeling, and
testing 是一分词短语，在句子中代替定语从 句做定语，即：
OTC drug monographs are a kind of "recipe book" which covers acceptable ingredients, doses, formulations, labeling, and testing. recipe book：处方集 整句译为：
the Nonprescription Drug Advisory Committee 非处方药咨询委员会 meets regularly： 定期举行会议
which meets regularly to assist the agency in evaluating issues surrounding these products：
涉及范围从……到……
该句译为：
前的非处方药有八十多种，涉及 范围从治痤疮药到减肥药。
As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks.
该句翻译为：
由于此原因，FDA对OTC药品成分 和标签的评审一直在进行着，并 成为了“OTC药品审核计划”中 一个部分。
The goal of this program is to establish OTC drug monographs for each class of products. OTC drug monographs: OTC药品专论 monograph是药典的正文，记载药品、
非处方药起着极其重要的作用；
health care: 卫生/医疗保健
by providing easy access to certain drugs : 这是一个介词短语，表示使得 容易得到（买到），让人们容易得到 某些药品；
that can be used safely without the help of a health care practitioner 是 一个定语从句，修饰前面的先行词 certain drugs：那些可以不需保健从 业人员（医生）帮助就能安全使用的
Most OTC drug products have been
marketed for many years, prior to the
laws that require proof of safety and
effectiveness before marketing. prior to: 介词短语 在……之前 全句译为： 大多数OTC药品在要求在上市前提供 安全、有效证据的法律颁布前就已经 上市多年了。
本句翻译为：FDA对OTC药品的审批 主要是由药品评审中心下属的非处方
药管理处来操作的。
However, scientists and regulators throughout CDER, the Office of General Counsel, and other Centers within FDA are routinely asked to assist in this massive effort. the Office of General Counsel：
prescription) 相当于一个非限制性定 语从句，即：the newer OTC drug
products, which were previously
available only by prescription, …
“switch” to OTC status： （原先只能凭处方够买的处方药）， 转变成了新的非处方药。 via the NDA process = by the NDer (OTC) drug products are those drugs that are available to consumers without a p该r句e是sc主ri从p复tio合n句.，其中限定性定语从
句修饰是those drugs
available 在句中译为：可以买到的
Products which conform to a monograph…
the New Drug Application (NDA) process： 新药应用申请 全句可译为：
收载在OTC药品专论中的药品，可以 事先不经FDA批准就上市，而那些未 收载在专论中的药品则必须通过独立 的审批和批准等新药应用申请过程。
CDER= Center for Drug Evaluation and Research 药品审评与研究中心
label：在文中作动词 上标签 outweigh : 比……重要/有价值
全句译为：
药品审评与研究中心对非处方药 品的监管与它对处方药品的监管 相同，以确保非处方药品必须恰 当地标明（有关事项）且药品的 益处重于（大于）风险。
药品。
全句可翻译为:
（因为）OTC药品（给消费者） 提供无需医生指导就能安全用药的 简易途径，它们美国的（医疗）保 健体系中起着越来越重要的作用。
This enables consumers to take control of their own health care in many situations. There are more than 100,000 OTC drug products marketed, encompassing about 800 significant active ingredients. take control of: 控制
The NDA process, and not the monograph process, is also used for new ingredients entering the OTC marketplace for the first time.
本句可译为:
新药申请过程不同于专论的完成过程, 它也被用于(帮助)药品新成分首次进 入OTC市场.
For this reason, FDA has been
evaluating the ingredients and labeling
of these products as part of “The OTC
Drug Review Program.” For this reason 由于此原因，即上一 句讲到的：大多数OTC药品未经安全 及有效性评估就已经上市。
该句是对 OTC drug 下定义。
There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight cloanssterso：l tdhreuragpepurtiocdcuatcetgso.ries ranging from…to…