Adds a new subsection (m) to 19 U.S.C. 1304 providing that the marking requirements of subsections (a) and (b) do not apply to finished drug products that are marked in accordance with 21 U.S.C. 352(b)(2)(A).

Amends 21 U.S.C. 352(b) to expand labeling requirements to include the name, place of business, and unique facility identifier of the manufacturer/packer/distributor (or a link/QR to a searchable electronic portal), add specific requirements for active pharmaceutical ingredients and finished drug products to identify original manufacturers, require paper/package-insert availability on request, define 'original manufacturer', and direct the Secretary to issue implementing regulations with a not-earlier-than-1-year effective date after final rule publication.