As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs. As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the […]
A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas. According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products. “The government alleges that Guardian manufactured and distributed purportedly sterile drug […]
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here). The initial draft guidance issued in 2014. According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s […]
In a prepublication Notice from the Federal Register (here), the field of products permitted for compounding by 503A and 503B compounders decreased by two. The Agency will publish a final rule on Tuesday titled List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness. The Agency […]
