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Int J Mol Sci 2024;25:11363
Moisture exposure may cause tablets to soften, discolor, stick together, or develop changes in texture
NAEs were identified using SOC = nervous system disorders (SOC ID: 10,029,205) and primary SOC = Yes, encompassing 1075 PTs from MedDRA version 27.0
With respect to possible enforcement of this policy, in FDAs press release FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize issued on October 2, FDA stated: FDA reminds compounders of the legal restrictions on making copies of FDA-approved drugs. This language suggests that FDA, in conjunction of with state Boards of Pharmacy may pursue enforcement action against compounders that continue to compound with this ingredient and possibly related combinations outside of the guidance and exemptions noted above
et al, 2022d
Reconstitute the contents with an appropriate sterile solvent according to your laboratory protocol
