Compounding with Sarah

  Regulatory Update – Clarification on the FDA’s Position on Compounding with Beta-Lactam Antibiotics   Why are compounders looking to compound amoxicillin? Amoxicillin (a beta-lactam antibiotic) for oral suspension is currently on acute shortage. A comprehensive list of products on shortage can be found at the FDA’s site here: FDA Drug Shortages .   Why the specific concern regarding beta-lactam antibiotics? Beta-lactam antibiotics are considered to represent a significant allergenic risk and cross-contamination between beta-lactam antibiotics and other drugs could potentially result in life-threatening allergenic reactions. The FDA has previously stated on their Insanitary Conditions at Compounding Facilities guidance for industry (GFI) that the processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products is considered to be insanitary.   May 503a compounding pharmacies compound amoxicillin oral suspension d...

  Regulatory Update: USP <795> and <797> By Sarah Taylor, PharmD The road to publishing the revisions to USP General Chapters <795> and <797> has been a long one. Since their initial publication in June of 2019, USP has received several appeals on <795> and <797>. These appeals included potential harm to patients, unjustifiable burden on established businesses, and concerns regarding the proposed guidelines departing from scientific  consensus. 1   Though these reasons for appeal continue to be sources of concern, USP published revisions to <795> and <797> on November 1st, 2022, stating they are  “to be official 01-Nov-2023”. 2,3   What does this mean for my practice? Until November 1st, 2023, the current version of General Chapter <795>, which was last revised in 2014, will remain in effect. Similarly, the current version of General Chapter <797>, which was last revised in 2008, will al...