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【drug-news】FDA warns pharmacies to stop mass-producing un
Pharmaceutical News
Published: Thursday, 10-Aug-2006
The Food and Drug Administration (FDA) has warned three firms, RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nation-wide.
Responsible officials at firms that do not properly address violations identified in FDA warning letters risk further enforcement, including injunctions that prevent further violations and seizure of their products that violate the law.
The three firms warned by FDA say that they produce inhalation drugs as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug. This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy compounding and the agency's action is not targeting this practice.
Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. These are potentially life-threatening conditions for which numerous FDA-approved drugs are available. Compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not know that they are receiving compounded products. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered.
"Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible."
FDA believes that, in compounding mass amounts of inhalation drugs, a number of pharmacies go well beyond traditional compounding. FDA is aware of certain pharmacies compounding millions of doses of inhalation drugs per year. These compounded drugs often simply copy FDA-approved, commercially available drugs, and any differences from FDA-approved drugs do not appear to be related to patients' medical needs.
http://www.fda.gov
报名后的练习，欢迎指正
FDA责令三家公司RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, 在全国范围内停止生产和销售未经批准的复方吸入剂。
公司有关负责人没有对FDA的警告信作出合理答复，他们将进一步得到强制性命令，以防止他们的违法产品猖獗造成更大危害。
这三家受FDA警告的公司声称生产吸入剂是对药剂配方的一次尝试。使用传统配方的药物在商业上是不利的，例如病人对FDA批准的药物中的一种成分过敏，医生根据病人的需要选择合适配方的药物，而FDA批准的药物不能满足这种情况。FDA通常只批准传统配方，而企业的工作不只于此。
吸入剂可用于治疗哮喘,肺气肿，支气管炎，纤维囊泡症。多数FDA批准的药物对有潜在性生命危险的病症有效。复方吸入剂可在多种状态下给药，病人和医生可能觉察不到正在使用复方药物。FDA督促使用吸入剂的消费者向医说明情况，向药剂师证实他们按医嘱用药。
“复方吸入剂没有得到FDA有效性和安全性评价，通常也没有按照GMP要求生产，不能保证无菌，可能将给患者带来不必要的危险，”FDA药品评价与研究中心主任Dr. Steven Galson发言，“为避免这些危险，我们鼓励患者在任何情况下都使用FDA批准的药物。”
FDA相信，在配料方面，许多药房配制的吸入剂优于传统配方。FDA注意到一些药房一年配制数百万的吸入剂，这些往往是简单的仿照FDA批准上市的药物，所不同的是表面上与患者的需求联系起来。 这个是转载,楼上的可以比照一下.俺还在摩拳擦掌中……
美国FDA警告3家药店停止大量生产未批准的吸入药
（美国FDA发布；2006年8月10日）
FDA已警告3家公司（RoTech Healthcare公司、CCS Medical公司和Reliant Pharmacy Services公司）停止生产和在全国销售数千剂未经批准的配制的（compounded）吸入药。未正确解决FDA警告函中指出的违规行为的公司，其负责人员将冒被进一步强制执法的风险，包括预防更多违规的禁令以及对其违法产品的扣押。
被FDA警告的这3家公司称，他们生产的吸入药是一种药房制剂(pharmacy compounding)操作。传统药房制剂通常涉及药房配制的市场上无法获得的药物，例如某种独特的药，用于对FDA批准的某种药中的某种成分过敏的患者。只有在医生确定其患者具有不适于FDA已批准药物的特殊医疗需求后,这种调配才能进行。FDA通常允许传统药房制剂，并且FDA的行动不会针对这种操作。
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作者:admin@医学,生命科学 2011-02-13 17:11
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