On December 19, 2024, the FDA finalized its reexamination of its initial decision (on October 2, 2024) that the tirzepatide shortage had been resolved. This comes after compounders of the drug ran to court to challenge the Agency’s initial decision. The latest notice of the shortage’s resolution came yesterday in a declaratory letter (here), issued by the […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
In late September, the FDA announced that Tirzepatide is no longer in shortage. However, last week, the Outsourcing Facilities Association, an industry compounding group, initiated a lawsuit to challenge the FDA’s decision. As a result, the FDA has paused any enforcement or regulatory action and will reevaluate whether the drug is actually in shortage based […]
As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (DHHS) Secretary Becerra has determined that public health emergencies (PHEs) resulted from the devastation caused by hurricanes Helene and Milton. Because of the disruption to the availability of certain parenteral products, the […]
Just a brief follow-up on our post of October 3rd (here) regarding the FDA’s determination that the drug shortage for Tirzepatide is over and the Agency’s “reminder” that, because the shortage has been resolved, 503B compounders should no longer be making the product. Well, a story by Brendan Pierson published by Reuters today (here), titled […]
Yesterday, the FDA published a “reminder” clarifying the status of compounded Tirzepatide now that the shortage for this GLP-1 product has been resolved. After confirming with the approved manufacturer of Tirzepatide that they now have sufficient supplies to meet current market demand, FDA is “reminding” both 503A and 503B compounders that, since the product is […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
While the fees for outsourcing facilities all went up this year, at least the increases in these fees won’t break the bank (at least not yet). These fees represent the inspection fees associated with outsourcing facilities (better known as compounding facilities) under section 503B of the Federal Food, Drug, and Cosmetic Act. They are designed […]
On June 6, 2024, the FDA warned patients and healthcare professionals of the potential danger of sulfites in compounded medications. Remember that prescription products that contain sulfites are required by law to contain a sulfite warning due to the potential for serious adverse events in patients who have sulfite allergies. The warning (here) notes that the […]
For anyone who wishes to gain a better understanding of all the complexities of running a 503A compounding pharmacy, a new resource is now available. The International Society of Pharmaceutical Engineering (ISPE) recently published a new Guide titled “Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies” (here). Some of you reading […]
