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"Lyophilized pharmaceutical forms: development and regulatory aspects." Drug Discovery Today
Ye J, Huang X, Hsueh EC, Zhang Q, Ma C, Zhang Y, Varvares MA, Hoft DF, Peng G
If the FDA were to reclassify any of the removed Category 2 substances into Category 1, compounding pharmacies would be able to resume lawful use of those substances under the interim policy without waiting for completion of the formal rulemaking process
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