Drugs

FDA Issues Interim Compounding Guidances

FDA has issued two interim guidance on the use of bulk drug substances in compounding under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. An agency statement (includes links to guidances and other documents) says the guidances explain FDA’s policy about the conditions under which it does not intend to take enforcement action against state-licensed pharmacies, federal facilities, and licensed doctors (under Section 503A) or outsourcing facilities (under Section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections.

“FDA is issuing these guidance documents to avoid unnecessary disruption to patient treatment while FDA evaluates the bulk drug substances nominated for use in compounding under Sections 503A or 503B of the FD&C Act,” the statement says. “Additionally these guidance documents clarify the process FDA is using to evaluate these substances.”

The three categories of bulk drug substances nominated by the public for use in compounding include:

Category 1 - those nominated for inclusion on the list of bulk drug substances that can be used in compounding under the two sections with sufficient information for FDA to evaluate them and do not appear to present a significant safety risk in compounding at this time;
Category 2 - those nominated with sufficient supporting information for FDA to evaluate them and present significant safety concerns, making them not eligible for the policy applied to those in the first category; and
Category 3 – those nominated without sufficient supporting information for FDA to evaluate them and thus not eligible for the policy applied to Category 1 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

Read more

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