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Unlike simple water for injection (WFI), BAC water remains sterile-usable for 28 days after vial puncture crucial for protocols that require repeated withdrawals from the same vial unit

Comment: Several commenters cautioned CMS to avoid defaulting to extensions in cases where broader relief is warranted and ensure reporting extensions are not disproportionately utilized in place of exceptions

(It would be illegal under the Federal Food, Drug, and Cosmetic Act for a manufacturer to sell an unapproved product in the U.S

Monitor blood pressure, heart rate, and metabolic parameters during use

10.1096/fj.09-147421 49 MamgainR.KosticM.SinghF

However, phenylamides were regarded as a more powerful anti-tyrosinase agent than the other pollen components (147)