FDA发布《原料药组合兽药》草案

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FDA Releases Draft Guidance on Animal DrugCompounding from Bulk Drug SubstancesFDA发布《原料药组合兽药》草案

2015年05月18日

FDA releases draft guidance on animal drug compounding from bulkdrug substances

As part of its overall efforts to address compounded drugs, theU.S. Food and Drug Administration today released a draft “Guidance for Industry(GFI) #230, CompoundingAnimal Drugs from Bulk Drug Substances.”Current law does not permit compounding of animal drugs from bulk drug substances,but the FDA recognizes that there are limited circumstances when an animal drugcompounded from bulk drug substances may be an appropriate treatment option. （现在的法规禁止原料药混合制成的兽药，但是FDA意识到现在存在一些限制情况当通过原料药混合制成的兽药是一张合适的治疗选择）FDA’s GFI #230 outlines specific conditions under which theagency generally does not intend to take action against state-licensedpharmacies, veterinarians, and facilities registered as outsourcingfacilities when drugs are compounded for animals from bulk drug substances.（FDA行业指南#230概述了具体的情况，在这些具体情况下, ，当他们使用原料药混合制成兽药时,FDA一般不打算对州许可的药店，兽医师和注册为外包机构的反对并采取行动）

The DrugQuality and Security Act, which amended the human drug compounding provisions in theFederal Food, Drug, and Cosmetic Act (FD&C Act) and created a new section503B of the FD&C Act for outsourcing facilities, provides certain statutoryexemptions for compounded human drugs, but the law does not apply to drugscompounded for animal use.

药品质量和安全法案修订了<联邦食品，药品和化妆品法案>中的人用药品混制的条款，并针对外包机构制定新的<联邦食品，药品和化妆品法案>503B部分，对混制人用药品提供一定的法规免除权，但是该法律不适用于兽用混制药品。

There are circumstances where there is no approved drug that canbe used or modified through compounding to treat a particular animal with aparticular condition. In those limited situations, an animal drug compoundedfrom bulk drug substances may be an appropriate treatment option.

经常出现这种情况——在特殊的情景下没有批准的药物能或者通过混合改制的能有效用于用于特定动物，在这种限制性情况下，通过原料药混制的兽药可能是一种合适的治疗选择。

“This draft guidance, once finalized, willhelp to ensure that animal drugs compounded from bulk drug substances areavailable for patient care without compromising the animal drug approvalprocess or jeopardizing the safety of the food supply,” said BernadetteDunham, D.V.M., Ph.D., director of the FDA’s Center for VeterinaryMedicine.

“该草案，一旦最终形成，将会帮助确保通过原料药混制兽药能被用于患病动物关怀，而不损害现在的动物药批准程序或损害食物链安全性。” Bernadette Dunham,博士说，FDA兽药中心主任。

In addition, the FDA is developing a list of bulk drugsubstances that facilities registered as outsourcing facilities under section503B can use to compound drugs for an individual animal patient or veterinarianoffice use under specified conditions. In a separate Federal Register notice,the FDA is requesting public input on which bulk drug substances should beplaced on this list.

除此之外，FDA正制定一份原料药名单，在特定的情况下,那些在503B部分下注册的外包机构可用这份名目来为患病动物个体或兽医师部门混制药品。在另一份联邦登记公告上，FDA正在邀请公众关于哪些原料药应该被收入该名单提供意见。

The agency also withdrew Compliance Policy Guide Section 608.400Compounding of Drugs for Use in Animals because it is no longerconsistent with the FDA’s current thinking on these issues.

FDA也撤销了“CompliancePolicy Guide Section 608.400 Compounding of Drugs for Use in Animals “，因为其和FDA关于这些问题的最新想法不在一致。

The draft guidance is available for public comment for 90 daysfrom the date of publication of the notice of availability in the FederalRegister. The public also has 90 days to submit nominations for the list ofbulk drug substances that may be used by outsourcing facilities to compounddrugs.

略

To electronically submit comments to the docket, visit www.regulations.gov and type the docket number in the search box.

·        FDA-2003-D-0202: DraftGuidance for Industry #230: Compounding Animal Drugs from Bulk Drug Substances

·        FDA-2013-N-1524: Requestfor Nominations: List of Bulk Drug Substances That May be Used by anOutsourcing Facility to Compound Drugs for Use in Animals

To submit comments to thedocket by mail, use the following address. Be sure to include the appropriatedocket number on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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Outsourcing Facilities

The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.”

The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (CGMP) requirements.

Outsourcing facilities:
&#8226;must comply with CGMP requirements;
&#8226;will be inspected by FDA according to a risk-based schedule; and
&#8226;must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.  

beiwei5du

是不是说明在部分特殊情况下复方制剂也可以有限制的使用呢？？？为什么会制定该行业指南草案呢？？？@Jason  

Jason

beiwei5du 发表于 2015-5-18 23:19
是不是说明在部分特殊情况下复方制剂也可以有限制的使用呢？？？为什么会制定该行业指南草案呢？？？[face3 ...

目前原料药也可以用于兽药的制剂，我们公司目前也是和某研发公司来共同开发大分子的药，可以用给兽药，也可以用于人药。FDA已经比较开明，将开拓这通路了。但是还是会有些限制的。

清风化雨

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jeanee

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syhorchid

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wct0526

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