CDER Ratcheting Up Expectations for Process Monitoring: Official
Evolving views on microbiological risks in drug manufacturing are driving a push at CDER toward greater emphasis on process monitoring over particular test points, center officials say. Because test results are often influenced by sampling bias, and cleanroom detection of contamination is “rare,” CDER plans to ease up somewhat on its traditionally aggressive oversight of testing compliance, David Hussong, associate director for new drug microbiology, Office of Pharmaceutical Science, said. He spoke at a recent workshop hosted by the U.S. Pharmacopeia in Rockville, Md. . . . more
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Compounder’s Recall Reignites Congressional Criticism of FDA Oversight
A recent recall by a New Jersey-based specialty pharmacy has reignited congressional criticism that the FDA is not doing enough to protect the public from contaminated compounded drugs. In a recent letter to FDA Commissioner Margaret Hamburg, Sen. Richard Blumenthal (D-Conn.) suggests mold-tainted bags of magnesium sulfate intravenous solution compounded by Med Prep Consulting would not have entered the supply chain had the agency followed its own internal compliance policy. . . . more
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Avastin Repackager Issues Recall After Off-Label AMD Use Goes Awry
Clinical Specialties, a compounder and repackager, is recalling 78 lots of single-dose syringes of cancer drug Avastin after receiving reports of eye infections, the FDA says. The company received reports of five intraocular infections from a physician’s office after an ophthalmologist administered Genentech’s Avastin (bevacizumab) off label to treat age-related macular degeneration (AMD), according to a recent safety alert. . . . more
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FDA Warning Letter to Apotex Casts Doubt on Drugmaker’s Process Controls
An imprecise media fill protocol and poor probes into speckled tablets have landed Apotex a warning letter in which the FDA questions the heft of the generic-drug maker's process controls. The recently posted letter follows a mid-August inspection of two of the company's Canada facilities that found "significant violations" of current good manufacturing practices (cGMP). It was also prompted, in part, because Apotex's response to the findings fell short, the letter states. . . . more
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Drugmakers, INTERPOL Collaborate in Global Initiative to Combat Illicit Drugs
More than two dozen drugmakers are teaming up with INTERPOL in a $5.8 million agreement to battle counterfeit drugs. The three-year program will focus on the prevention of all types of pharmaceutical crime, including brand- and generic-drug counterfeiting as well as identifying and dismantling of organized crime networks. The deal will see the creation of INTERPOL’s Pharmaceutical Crime Program to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime unit. . . . more
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GS1 Guideline Gives Examples on Product Serialization, Sharing Traceability Data
As the 2015 deadline for California's drug pedigree requirements draws closer, GS1 Healthcare US has developed a draft implementation guide for serializing pharmaceutical products and sharing pedigree and traceability data using GS1 standards. The FDA requires pharmaceutical products to be marked with a linear barcode that carries their national drug code. . . . more
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