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National Law Review (Polsinelli PC) was explicit on April 22, 2026: removing a Category 2 bulk drug substance does not, on its own, authorize use of that substance in compounding or bring it within FDAs interim enforcement discretion policy for substances in Category 1. Even Category 1 substances are only under enforcement discretion, which is short of full authorization

The minimum order is 10 units (one box) per reference, sold either as unbranded bulk vials or white-labelled with your own brand

CVOs include the pineal gland, the organum vasculosum of the lamina terminalis (OVLTs), the subfornical organ (SFO), the choroid plexus, the region postrema (AP), the pituitary glands posterior lobe, the subcommissural organ, and the median eminence (ME) of the mediobasal hypothalamus