Currently, cBHRT is not on FDA’s list of difficult to compound products, falling under certain exemptions of the FD&C Act, particularly, Sections 503A and 503B. Under Section 503A, a human drug compounded for an identified individual patient based on a prescription qualifies for exemption from three sections of the FD&C Act: 1) current good manufacturing practice for drugs; 2) labeling of drugs with adequate directions for use; and 3) approval of human drug products under new drug applications or abbreviated new drug applications. One of the criteria for these exemptions is that the Secretary has not identified the drug, by regulation, as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. However, before the Secretary may promulgate regulations to add a drug to the difficult to compound list, it must convene and consult an advisory committee on compounding of such drug(s), unless the Secretary finds that issuance of such regulations before consultation is necessary to protect the public.Continue reading
