Drugs

Pharmacists Group Pressuring FDA on Supply Chain Security

The American Pharmacists Association (APhA) is urging pharmacies to join them in calling for FDA to postpone the upcoming Drug Supply Chain Security Act (DSCSA) — known as the “track-and-trace” law —requirements for small business dispensers to allow for more time to comply with the requirements, which go into effect 11/27.

Several DSCSA requirements for pharmacies (dispensers) are already in effect. Last month, APhA submitted a request to FDA to exercise enforcement discretion and give pharmacies/dispensers with 25 or fewer full-time employees additional time to comply with the DSCSA requirements for electronic, enhanced drug distribution security.

DSCSA outlines certain requirements for enhanced drug distribution security. “The goal is to create an electronic, interoperable exchange of information that identifies and traces certain prescription drugs down to the package level as they move through the supply chain to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs,” APhA says.

“Implementing the upcoming DSCSA requirements is a critical issue for small pharmacies employing 25 or fewer people,” the group says. “FDA has not started the feasibility study that’s required to evaluate the impact on small pharmacies, so it is unclear what they will need to do.”

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