黑色加粗处不知道该怎么翻译，求助

黑色的地方不知道啥意思，有的不知道啥结构，请求指教。晚上也会好好看看语法书，希望尽快摆脱有道式翻译

1.     

How does registration as a human drug compounding outsourcing facility under section 503B work?

1.根据503B章节，如何注册人用药调制外包场所？

To register as an outsourcing facility, a compounder must send an email or use the electronic registration system to provide the following information: name; place of business; unique facility identifier; point of contact email address; an indication of whether the facility intends to compound products on FDA’s drug shortage list; an indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile drugs from bulk drug substances.

为了注册外包场所，调制者必须发送一个email或使用电子注册系统，提供下列信息：名字，商业地点（place与address有什么区别），唯一的设施识别号，联系的电子邮件地址，指出工厂是否意在调制FDA药物短缺清单上的产品，指出工厂是否调制原料药, 如果是，场所是否是用于将原料药制作无菌药物。(bulk drug substance该如何翻译）

When FDA receives a submission for registration, FDA will review the submission to determine whether the required information has been provided, and if so, the outsourcing facility will be considered registered. If the information is not complete, FDA will contact the registrant and ask that they provide the necessary information. A firm will not be considered registered until the information is complete.

当FDA接收到注册申请，FDA会审核该申请，决定信息是否提供完全，如果信息提供完全，这个外包场所将被认为已经注册了。如果信息提供不完全，FDA将会联系注册者，让其提供必要的信息。直至信息补充完全，公司才会被认为已注册。

Beginning October 1, 2014, outsourcing facilities will be required to pay a fee at the time of registration. The amount of this fee and directions for paying the fee will be published in the Federal Register in early August 2014. Facilities for which the proper fee has not been received on or after October 1, 2014 will not be considered to be registered and will be removed from this list of registered outsourcing facilities.

从2004.10.1日开始，外包场所在注册的同时，将被要求支付费用费用。金额和支付费用的方式将在2014年8月初的联邦公报上公布。在2014.10.01当天或之后还没有收到正确费用的工厂将被认为没有注册，并会被移出注册的外包场所清单。

2.       

What happens after a facility first registers with FDA as an outsourcing facility under section 503B?

2.根据503B章节，一个工厂第一次作为外包场所在FDA注册会发生什么？

Once an outsourcing facility is registered, the facility is subject to inspection by FDA and will be added to the list of facilities FDA intends to inspect. Outsourcing facilities are to be inspected according to a risk-based schedule. Depending on the number of outsourcing facility registrants and other inspection priorities, FDA expects to inspect newly registered outsourcing facilities within two months of initial registration, if the facility has not been previously inspected.  Subsequent inspections will depend on the findings from the first inspection and other factors including but not limited to: the compliance history of the outsourcing facility; the record, history, and nature of recalls linked to the outsourcing facility; the inherent risk of the drugs compounded at the outsourcing facility; the inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected within the last 4 years; and whether the outsourcing facility has registered as an entity that intends to compound drugs in shortage.

一旦外包场所已注册，工厂属于FDA检查，将会被加入FDA将要检查的工厂清单。根据基于风险的制度进行外包场所检查。如果工厂之前没有检查过，FDA预期在初始注册2个月的时间内检查新注册的外包场所，取决于外包场所注册的数量和其他检查的重要程度。后续的检查取决于第一次检查的发现和其他因素包括但是不限于：外包场所的符合性历史；与外包场所相关的记录，历史，召回的性质；在外包场所调制药物的内在风险；外包场所的检查频率和历史，包括外包场所在最近4年是否被检查过；外包场所是否作为要调制短缺药物的一个实体注册。

3.      

 What does it mean to be registered as a human drug compounding outsourcing facility under section 503B?

3.根据505B的规定，注册成为人用药调制外包场所意味着什么？

Registration means only that FDA has received the information required to register the facility. It does not mean that the facility is making FDA-approved drugs and it does not mean it is in compliance with current good manufacturing practice requirements, the other conditions of section 503B, or other requirements in the Act. Approval of a drug requires the submission and approval of a new drug application or an abbreviated new drug application. Facilities registered as human drug compounding outsourcing facilities are required to comply with current good manufacturing practice requirements; report adverse events to FDA; label their products with certain information; and meet certain other requirements if they are to qualify for the exemptions from the new drug approval and adequate directions for use requirements of the Act. Outsourcing facilities that comply with the conditions for exemption under section 503B are not required to obtain new drug approvals. Listing of an outsourcing facility on this list does not mean that FDA has determined that the outsourcing facility is in compliance with these requirements or that it has met the conditions to qualify the exemptions under section 503B.

注册仅意味着FDA已经接受了要求注册工厂的信息。不意味着该工厂可以制作FDA批准的药物，也不意味着它符合CGMP要求、503B章节的其他条件，或者法案的其他要求。药物的批准要求一个新药或者仿制药的递交和批准。注册为人用药物调制用 外包场所的工厂要符合cGMP规定；向FDA报告不良反应；产品标签有特定信息；如果他们要符合新药批准和 adequate directions for use requirements of the Act 则要满足特定的要求；符合503B章节规定的豁免条件的外包场所不需要获得新药批准。清单上的外包场所的列表不意味着FDA已经确定外包场所符合这些条件或者满足503B规定的豁免条件。

4.       

If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?

4.如果FDA已经检查了一个人用药调制外包场所，我能确定我从这个工厂购买的药是安全的吗？

Drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product. 

由制药公司制作的药物，包括在人用药调制外包场所制作的，都不是FDA批准的。这意味着它们没有作为已批准药物经过相同的上市前审核。它们缺少FDA的安全和有效性和生产质量的审核。因此，当FDA已批准的药物是市售可获得的，FDA推荐医生开FDA已批准的药物，而不是调制药，除非医生判断调制产品对于特定的病人是必须的，相较于FDA批准的市售制剂，能有显著的差异。

Although the drugs will not be FDA approved, purchasers of drugs compounded at a registered outsourcing facility that has had a recent satisfactory FDA inspection will have some assurance that the conditions at that facility met applicable current good manufacturing practice standards at the time of the inspection, and the compounded drugs are labeled with the required information. It should be noted, however, that FDA inspections are just a snapshot in time. Conditions at the facility can change at any time. And FDA only reviews a small sample of the records available at a facility during an inspection and must draw conclusions about the conditions and practices at the facility from that small sample of records. Purchasers should look at other available information about the facility that can provide them with additional insight with regard to the facility’s operations.

虽然药物不会被FDA批准，但是在已经注册过的并近期经FDA进行满意的检查的调制外包场所调制的药物，用户将会得到保证，保证在检查时工厂满足CGMP标准，调制药物的标签含有特定信息。然而，值得注意的是FDA检查只是一个时间段的参考。工厂的情况在任何时候都能改变。在检查过程中FDA只审核工厂中可获得记录的一小部分，从这一小部分的记录必须得出关于工厂的情况和实行的结论。用户应该查看其它关于工厂的可获得的信息，这些信息能提供关于工厂操作额外信息。

5.     

  If I purchase drugs from a company that has multiple facilities, how can I be sure about the quality of the specific compounded drugs I purchase?

5.如果我从有多个工厂的一个公司购买药物，我怎么确定购买的特效调制药品的质量？

Registration and inspections are facility specific and do not apply to all facilities under common ownership and control. Before purchasing drugs from a corporate entity, you should determine that the specific facility in which the drugs are compounded is a registered outsourcing facility with a satisfactory inspection.

注册和检查是工厂特有的，不适用于共同所有权和控制的所有厂。在公司实体购买药物之前，你应该确定药物调制的特定场所是有满意检查结果的已注册的外包场所。

6.      

 What does an outsourcing facility do?   

6.外包场所应该做什么？

Under section 503B, outsourcing facilities that compound human drugs may register and meet certain other requirements to qualify for the exemptions from the new drug approval requirements and the requirements for adequate directions for use. Under section 503B, an outsourcing facility is a facility that:

Is engaged in the compounding of sterile drugs

Has elected to register as an outsourcing facility

Complies with all of the requirements of section 503B

Is not required to be a licensed pharmacy, but compounding must be by or under the direct supervision of a licensed pharmacist

May or may not obtain prescriptions for identified individual patients

When registering, an outsourcing facility must pay a fee. Registering as an outsourcer means that the compounding pharmacy will be inspected according to a risk-based schedule.

根据503B章节，调制人用药的外包场所应该注册，为了符合豁免新药批准要求而满足其他特定要求和为了方便使用的足够的指示。根据503B章节，外包场所应：

用于调制无菌制剂

已作为外包场所注册

符合503B章节的所有要求

不要求是Licensed pharmacy,但是调制必须由或者在执业药师的监督下

特定的病人不一定需要处方

注册时，外包场所必须付费。作为外包商注册意味调制药厂将根据基于风险制度来检查。

7.      

 Is it safe for me to purchase drugs in shortage from a registered outsourcing facility?

7.从一个已注册的外包场所购买短缺药物是否安全？

Drugs compounded in registered outsourcing facilities that have had a satisfactory FDA inspection may have more assurance of safety than those made by other non-registered compounders because they are to be made in accordance with current good manufacturing practice standards. However, drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, or an alternative FDA-approved drug can be used, the FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product. 

相较于在没有注册过的制药公司制造的药物，在已注册的有满意的FDA检查的外包场所调制的药物更有安全性的保障，因为后者符合CGMP标准。然而，由制药公司制作的药物，包括那些在人用药调制外包场所制备的药物，不是FDA批准的。这意味着他们不是作为已批准药物经过相同的上市前审核。他们缺少FDA安全和有效性和生产质量的审核。因此，当FDA批准的药物是市售可获得的，或者有替代的FDA批准药物可以使用，FDA推荐医生开FDA已批准的药物，而不是调制药，除非医生判断调制产品对于特定的病人是必须的，且相较于FDA批准的市售制剂，能有显著的差异。

For drugs compounded by registered outsourcing facilities that are on the FDA Drug Shortage List, the drug must be compounded after the drug is placed on the drug shortage list and may not be dispensed or administered to a patient after it has been removed from the drug shortage list. Therefore, compounders may place shorter beyond use or expiration dates on such products to ensure that they will be used within this period and compounders and purchasers will not be left with inventory of drugs that cannot be used because they are no longer in shortage.

对于在FDA药物短缺清单上的已注册的外包场所调制的药物，药物被列入药品短缺清单之后，药物必须调制，已经从药物短缺清单中被移之后，不应该再分发给病人。因此，调制者将这些药品的有效期定的很短，以至于能保证他们在这段时间可以使用，制药公司和用户不会留有不能使用的药物库存，因为他们不再短缺。

8.    

If a facility that was on the list no longer appears on the list, why would it have been removed?

A facility is removed from the list if it is no longer registered. For example, a facility could be removed if it notifies FDA that it no longer wants to be considered registered as an outsourcing facility, or if its registration is not renewed during the annual re-registration period of October 1 – December 31.

8.如果一个工厂原来在清单上，但是之后再也没有出现在清单上，为什么被移出？

如果工厂不再注册，将从清单上移出。例如，如果工厂通知FDA它不想再作为一个外包场所注册了，或者在年度再注册10.1-12.31阶段它的注册没有更新，该工厂就会被移出清单。

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm389118.htm