Sec. 3. Quality Management Maturity Sterile Injectable Drug Pilot Program

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Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall commence the Quality Management Maturity

(QMM)Sterile Injectable Drug Pilot Program (referred to in this section as the pilot program ) under this section. Under such program, the Secretary shall— select eligible drug manufacturers to participate in the program in accordance with paragraph (2); and contract with a third-party contractor to develop a QMM assessment tool and conduct assessments, in cooperation with staff of the Food and Drug Administration, of each participant’s quality management system. To be eligible to participate in the pilot program under this section, a manufacturer shall— be a for-profit or nonprofit entity; manufacture a prescription drug that is a sterile injectable drug; manufacture a drug that is deemed an essential medicine under Executive Order 13944 (85 Fed. Reg. 49929); have received a final classification of No Action Indicated or Voluntary Action Indicated with respect to all inspections of all manufacturing facilities of the entity conducted by the Food and Drug Administration within the 5-year period immediately preceding the date of enactment of this Act; be a person who has registered one or more establishments under subsection (b)(1) or (i)(1) of section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ), with respect to the manufacture of a prescription drug described in subparagraph (B); and agree to— permit a third-party contractor to conduct regular assessments under the QMM pilot program, as described in paragraph (3), either on-site or remotely; collect and submit metrics data to the Food and Drug Administration and the contractor by an agreed upon date, prior to each assessment described in clause (i); and be available for consultations with the third-party contractor and the Food and Drug Administration prior to and after each assessment described in clause (i), including discussions regarding the participant’s established QMM-related activities and the contractor’s post-assessment recommendations regarding these activities. Assessments that are conducted jointly by a third-party contractor, in cooperation with staff of the Food and Drug Administration, will regularly conduct manufacturer facility assessments to determine the manufacturer’s quality management maturity progress or status. Pilot program assessments will cover multiple topics and shall include— supply chain management; manufacturing strategy and operations; safety, environmental, and regulatory compliance; inventory management; performance management and continual improvement; risk management; management review and responsibility; planning; workforce management; quality culture; and customer experience. Not later than 6 months after the date of enactment of this Act, the Secretary shall publish instructions for applicants in the Federal Register. Such instructions shall include a timeline for the application period for such program, and a 1-year timeline for the pilot program following such application period. Not later than 6 months after the completion of the pilot program, the Secretary shall submit a report to Congress on such pilot program. Such report shall include— a summary of third-party assessments of each participating manufacturer’s quality management system; recommendations on next steps towards developing a publicly available Food and Drug Administration rating system for quality management maturity systems of sterile injectable drug manufacturing facilities, including specific drugs manufactured at each facility; considerations the Food and Drug Administration may take in updating guidance of current good manufacturing practice of sterile injectable drug products; and recommendations on incorporating pilot programs (or related work) described in the guidances entitled, Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement , issued by the Food and Drug Administration on October 16, 2020 (85 Fed. Reg. 65824), and Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement , issued by the Food and Drug Administration on October 16, 2020 (85 Fed. Reg. 65828), into publicly available Food and Drug Administration rating systems for overall quality management maturity systems. In this section, the term sterile injectable drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), a biological product licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), or a combination product (as described in section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) whose primary mode of action is that of a drug or biological product, whose manufacturing, distribution, and administration processes require sterile conditions.

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