其 他 安 全 警 示
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| The United States: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (English Only) |
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The US Food and Drug Administration (FDA) announces that a federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the FDA, Guardian Pharmacy Services continued to violate the law, putting patients at risk.
The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or rendered otherwise harmful to patients. According to the complaint, Guardian also manufactured and distributed drugs that were misbranded because their labels did not include adequate directions for patient use, which describe how to use a drug safely and effectively for its intended purposes. Some of Guardian’s drugs were also misbranded because their labels were false or misleading.
The consent decree requires Guardian to cease sterile operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act. Under the consent decree, Guardian may not resume sterile compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.
The FDA conducted an initial inspection of Guardian in 2016 that resulted in a warning letter for insanitary conditions and other violations of the FD&C Act. In 2017, the FDA received adverse event reports concerning at least 43 patients who were administered eye injections of a drug compounded by Guardian containing triamcinolone (steroid) and moxifloxacin (anti-infective) during cataract surgery. These patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception and significant reductions in best-corrected visual acuity and visual fields. The FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin product revealed a high percentage of an excipient, poloxamer 407, and the presence of potential process degradation products. The FDA conducted a follow-up inspection in Apr 2018 and issued a risk alert to inform patients about these products in Jul 2018.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm633204.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by Guardian Pharmacy Services. Related news was previously issued by FDA, and was posted on the Drug Office website on 29 Jul 2017 and 16 Jun 2018.
Ends/Wednesday, Mar 13, 2019
Issued at HKT 15:00
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