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CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.
During normal business hours, questions may be directed to 1-800-835-4709. After business hours parties may call the FDA emergency operations line at 301-796-8240. These questions will be forwarded to the appropriate Center or office for advice.
Generic medicines are produced in factories all over the world. These factories must be approved by international regulators, including Medsafe, before they can provide medicines to New Zealand. Often, the factories that produce generic medicines are also producing the active ingredient for brand-name medicines. It doesn�t matter where in the world the factory producing the generic medicine is, the approval process and the standards for the medicines are the same. Generic medicines are often produced by major pharmaceutical companies that also develop original brand-name medicines. Many brand-name companies are now buying or going into partnership with generic medicines companies to expand the range of products they produce and broaden their revenue base.
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