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Why This Matters: A Quick Primer on Section 503A Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), human drug products compounded by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician can be exempt from three major FDA requirements: current Good Manufacturing Practice (cGMP) standards, certain labeling requirements, and the standard new drug approval process (NDAs/ANDAs)

Hendey GW, et al

biopharmaceutical drugs are unlikely candidates for chemical modifications to enhance their permeability across the blood-brain barrier

One such adaptation she and her colleagues have been studying is an increase in the amount of the enzyme glutamine synthetase, which makes glutamine from other starting materials, namely glucose