The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
In a previous blog posted on April 16, 2026 (here), we discussed the announcement from FDA regarding an upcoming meeting of the Pharmacy Compounding Advisory Committee to be held on July 23-24, 2026, focused on the inclusion of some active ingredients on the permitted pharmacy compounding list. That post identified seven peptide active ingredients that […]
Today, the FDA published a Federal Register (FR) notice (here) announcing a preliminary decision regarding three bulk drug substances that it “has evaluated and is proposing not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide.” The notice further states that the FDA will consider comments submitted to the docket until June 30, 2026 […]
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 […]
