Drugs

FDA Publishes 3 Drug Compounding Guidances

FDA has released one draft and two final guidances relating to aspects of drug compounding. The draft guidance, Insanitary Conditions at Compounding Facilities, describes examples of insanitary conditions observed by FDA at drug compounding facilities. The document specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products. FDA says it issued the guidance “to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions.” The guidance is also intended to help state regulatory agencies understand some examples of what FDA has considered to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health.

The second guidance, Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities, provides agency policy on the compounding and repackaging of radiopharmaceuticals for human use by specified types of facilities. The guidance describes the conditions under which FDA generally does not intend to take action when a state-licensed nuclear pharmacy, federal facility, or other facility that is not an outsourcing facility, and that holds a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State, compounds or repackages radiopharmaceuticals for human use. The document lists seven items not addressed by the guidance and says the guidance does not alter the agency’s current guidances addressing investigational new drugs.

Finally, Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities, describes conditions under which FDA generally does not intend to take action for violations of the law when an outsourcing facility repackages radiopharmaceuticals. It lists six items not addressed by the guidance and again says that the document does not alter current guidances addressing investigational new drugs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome