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doi: 10.1023/A:1018863716749 160 SchirraJHouckPWankUArnoldRGkeBKatschinskiM

Animal studies have shown adverse developmental outcomes, and while human data are limited, the precautionary principle supports medication discontinuation before conception

Despite this new focus, FDA reminded pharmacies of a limited enforcement safe harbor for 503A compounders: the agency does not currently intend to take action against a pharmacy that compounds an essentially a copy product, provided it fills no more than four prescriptions of that preparation per calendar month