“To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.”
No CRS summary available for this bill.
This section revises restrictions on compounding by licensed pharmacists and physicians under section 503A(b) of the FD&C Act by (1) limiting such compounding of any drug product that is essentially a copy of a commercially available drug product to no more than 20 times in a single month (from a general prohibition); and (2) defining "essentially a copy of a commercially available drug product" as one that contains any active ingredient from a commercially available product without a patient-specific change producing a significant difference, as determined by the prescribing practitioner, and defining "commercially available drug product" as one sold in the U.S. market in facilities complying with current good manufacturing practice requirements (section 501(a)(2)(B)) and not listed as discontinued under section 505(j)(7)(A). (Thus, section 503A—which exempts patient-specific compounding from new drug approval, adverse event reporting, and current good manufacturing practice requirements—allows limited duplication of approved drugs.)
This section establishes an annual reporting requirement under section 503A of the Federal Food, Drug, and Cosmetic Act for pharmacies, facilities, or physicians that, in calendar year 2025 and each year thereafter, compound more than 20 times in a single month—for patients residing outside the state in which the compounding occurs—any drug product containing an active ingredient found in a commercially available drug product (as defined in subsection (b)(2)(B)). Each report must identify (1) each type of such drug product compounded for those patients and (2) for each month, the total number of times each type is compounded; reports are due by year-end in a form and manner prescribed by the Secretary of Health and Human Services. The requirement excludes compounding by hospital pharmacies for patients on hospital premises. (Section 503A exempts drugs compounded by licensed pharmacists or physicians for identified patients from certain FDA approval, labeling, and adulteration requirements if specified conditions are met.)
This section establishes enhanced inspection requirements under section 503B(b) of the Federal Food, Drug, and Cosmetic Act for large-scale outsourcing facilities (i.e., those compounding more than 100 units of any single drug product in a calendar year), requiring (1) an inspection prior to the facility's first compounding of any drug product and (2) reinspection at least biennially. It further eliminates the registration exemption for outsourcing facilities under section 510(g)(1), requiring such facilities to register annually with FDA as drug establishments do. The amendments apply beginning six months after enactment.
This section revises the base establishment fee for outsourcing facilities that compound drugs from $15,000 to a base amount deemed appropriate by the Secretary to fund activities ensuring the safety of compounded drug products.