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PLoS ONE 9:e105757 Li Q, Fu C, Liang C, Ni X, Zhao X, Chen M, Ou L (2022) Crop lodging and the roles of lignin, cellulose, and hemicellulose in lodging resistance

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While federal law has long carved out exceptions for pharmacists to mix custom medications for individual patients, the sheer scale of current operations has blurred the line between traditional pharmacy practice and unapproved manufacturing. For intellectual property (IP) attorneys, regulatory affairs directors, and biopharma executives, the urgent question is no longer theoretical: At what point does the volume, scale, and marketing of a compounded drug cease to be a regulatory exemption and become actionable patent infringement