Final Standards for Allergen Extract Compounding under USP Chapter 797 The long-awaited new USP Chapter 797 standards on sterile compounding were released June 1 and take effect Dec. 1. Read the final approved USP letter here. Have questions? Attend the AAOA…
FDA has a drug shortage database which includes reasons for and updates on drug shortages. Today the database read, “Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen® and the authorized generic version, continues to experience manufacturing constraints. Currently, supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. Patients who are experiencing difficulty accessing product should continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.”
Earlier this month, Mylan recently released a statement about the Pfizer company’s interruptions in the production of EpiPen®. Due to the manufacturing delay there is a shortage in the EpiPen® (epinephrine injection, USP) (0.3 mg) and the EpiPen Jr® (epinephrine injection, USP) (0.15 mg) Auto-Injectors.
Pfizer’s statement is here.
Possible reasons for the shortage may include a spike in sales during the back-to-school season. Schools have reported “stocking up” on EpiPens to prepare for the school year. Additionally, on August 16th 2018, the first generic version of EpiPen, developed by Teva Pharmaceuticals, was approved. The company has not issued a launch date and it may not launch soon enough to assist families currently searching for supply.