Do not treat biologics as ordinary bulk ingredients
FDA states that biological products are not eligible for the compounded-drug exemptions under sections 503A and 503B. A review request is not an exception to that rule.
Documentation to request
Require the exact hCG product record and labeled potency in international units. Distinguish a licensed finished product from a proposal to compound material.
Regulatory context: FDA: compounding, approval and quality standards. Source reviewed . This source does not verify the identity, testing or availability of our catalog references.
Related guidance: Product-by-product review for hormone clinics. These references support a review, not a treatment recommendation or supply authorization.