Reclassification is not supposed to be a route for unapproved drugs to get into the market, Janet Woodcock, a former FDA chief deputy commissioner who helped oversee the 2023 assignment of the peptides to category two due to safety concerns, told ProPublica before the meeting
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute, dissolve, or reconstitute drugs/compounds for injection. The pH is 5.7 (4.5 to 7.0)
Monitoring and assessment Tracking progress helps evaluate whether the compound is producing desired effects
Mechanism: Why Bacteriostatic
At a reconstituted concentration of 2mg/mL (with 2.5mL BAC water), each 5mg vial provides 5 x 1mg doses or 25 x 0.2mg doses