Posts Tagged ‘compounding’
PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
[...]PSM submits comment supporting the continued exclusion of GLP-1s from the 503B Bulks List
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
[...]Partnership for Safe Medicines releases action plan to protect patients from unapproved compounded GLP-1s
PMS’s new report outlines solutions to protect patient safety in the growing compounded GLP-1 marketplace. A Call to Action: Restoring and Strengthening America’s Patient Safety System serves as a roadmap for policymakers and regulators to uphold the gold standard system that protects Americans from untested and unsafe medicines.
[...]PSM applauds Indiana legislature for compounding and med spa reform
On February 26, 2026, PSM was glad to see the Indiana legislature pass SB 282, a bill that strengthens compounding and medical spa regulation to keep Indiana patients safer.
[...]PSM statement on ‘deeply concerning’ compounding of GLP-1 weight-loss pills
PSM Executive Director Shabbir Imber Safdar released the following statement in response to news that Hims & Hers is now compounding pill versions of a newly approved GLP-1 weight-loss drug.
[...]PSM urges the House Energy & Commerce Committee to support the SAFE Drugs Act of 2025
PSM wrote the House Energy & Commerce Committee in support of the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act, to help protect the American drug supply from unsafely compounded medication.
[...]PSM asks House Energy & Commerce Committee to oppose H.R. 5316, The Drug Shortage Compounding Patient Access Act
PSM sent a letter explaining how H.R. 5316 undermines critical patient safety protections.
[...]PSM signs letter of support for changes to Mississippi’s compounding pharmacy guidelines
The proposed updates aim to help address safety concerns created by pharmacies reselling compounded sterile drugs purchased from outsourcing facilities.
[...]What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]An FDA inspection revealed significant problems at Empower’s new outsourcing facility
After a November 2024 inspection, the FDA issued a Form 483 to Empower Clinic Services highlighting violations related to compounded drug manufacturing practices at its East Windsor, New Jersey facility.
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