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Proliferative changes in the pituitary and mammary gland of rodents have been observed following chronic administration of other antipsychotic agents and are considered prolactin-mediated

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April 22, 2026: Removed from Category 2 On April 15, 2026, the FDA published a 503A category revision removing 12 peptides from Category 2 effective seven calendar days later (April 22)

The FDA lists BPC-157 among bulk drug substances used in compounding that present significant safety risks, which limits routine compounding and prescription access in the United States

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