Reporting requirement

Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is amended— (1) by redesignating subsections (d) and (e) as subsections (e) and (f), respectively; and (2) by inserting after subsection (c) the following: (d) Reporting requirement (1) In general For calendar year 2025 and each calendar year thereafter, if a pharmacy, facility, or physician compounds, more than 20 times in a single month for patients who reside outside the State in which the compounding occurs, any drug product that contains any active ingredient found in a commercially available drug product (as defined in subsection (b)(2)(B)), such pharmacy, facility, or physician shall submit a report to the Secretary. (2) Contents Each report under paragraph (1) shall identify— (A) each type of drug product described in paragraph (1) that is compounded for a patient described in such paragraph; and (B) for each month, the total number of times each such type is so compounded. (3) Timing For any calendar year for which paragraph (1) applies, the pharmacy, facility, or physician shall submit the report under such paragraph not later than the end of such calendar year. (4) Form and manner A pharmacy, facility, or physician shall submit each report under paragraph (1) in such form and manner as the Secretary may prescribe. (5) Hospital pharmacy exclusion This subsection does not apply to the compounding of any drug products for hospital patients by a pharmacy located on the premises of the hospital..