We posted a blog earlier today (here) regarding the FDA’s announcement that it plans to review a number of drug substances at a two-day meeting, in July, of the Pharmacy Compounding Advisory Committee. Later in the day, the FDA released a document outlining additional plans to reclassify other drug substances, including several peptide drug substances, […]
The FDA has announced a two-day meeting of the Pharmacy Compounding Advisory Committee for the purpose of reviewing certain bulk drug substances nominated for inclusion in the Section 503A bulk drug substances list. The meeting is scheduled for July 23-24, 2026, and it will be held at the FDA’s White Oak Campus. The full notice from the […]
Every 3 months, FDA updates its New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System listings (here) to include newly identified potential serious risks that FDA is investigating. The FDA wants to emphasize that “[T]he appearance of a drug or biological product on a quarterly report does […]
Dr. Makary has indicated that the FDA will take an aggressive enforcement stance on GLP-1 compounded products as well as action on misleading advertising for such products. He has also indicated that the FDA will take decisive action against compounders that produce copies of approved drug products that do not have a required clinical difference. […]
The gauntlet has been laid down and now it’s also been run through the FDA and courts will tell the tale. With Novo Nordisk’s (Novo) suit against Him and Hers, the issue of 503B outsourcing facilities compounding of copies of FDA-approved products may hang in the balance. FDA has apparently taken a hard line on […]
The user fees for outsourcing facilities (also known as compounding or 503B facilities) have been announced! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and ADUFA. The establishment fee for a qualified small business and the re-inspection fee increased by […]
Airflow visualization studies (AVS) (also known as smoke studies) are an integral part of contamination control practices in GMP-controlled aseptic processing plants. As per regulatory guidelines such as the FDA’s 2004 Guidance on Aseptic Processing (here), USP <1116> (here), and PDA Technical Reports 13 (here), 22 (here), and 34 (here), these studies enable the measurement […]
With the FDA declaring the shortage of semaglutide over and the recent development that “U.S. District Judge Mark Pittman denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide, the active ingredient in Ozempic and Wegovy” (see here), […]
An Endpoints News story authored by Shelby Livingston titled “Compounders’ motion for preliminary injunction denied in case over tirzepatide shortage” (here; subscription needed) appears to give this round of the fight to declare the tirzepatide drug shortage over to the FDA. The Honorable Mark Pittman, U.S. District Court for the Northern District of Texas, denied […]
In the Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy) issued by the FDA on February 21, 2025 (here ), the Agency indicates that the supply of the innovator products either meet or exceed demand for Semaglutide Injection products. While the FDA acknowledges that there may be some patients that continue […]
