§ 356d. Coordination; task force and strategic plan

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title X § 1003 · 126 Stat. 993

   Enacted · 21 U.S.C. § 356d

   June 25, 1938, ch. 675, § 506D, as added Pub. L. 112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 506D, as added Pub. L. 112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103

   Enacted provision · exact public law section
   SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN.   Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 506C–1, as added by section 1002 of this Act, the following: “SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN. “(a) Task Force and Strategic Plan.— “(1) In general.— “(A) Task force.— As soon as practicable after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary’s response to preventing and mitigating drug shortages. “(B) Strategic plan.— The strategic plan described in subparagraph (A) shall include— “(i) plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking; “(ii) plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage; “(iii) plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared; “(iv) plans for considering the impact of drug shortages on research and clinical trials; and “(v) an examination of whether to establish a ‘qualified manufacturing partner program’, as described in subparagraph (C). “(C) Description of program.— In conducting the examination of a ‘qualified manufacturing partner program’ under subparagraph (B)(v), the Secretary— “(i) shall take into account that— “(I) a ‘qualified manufacturer’, for purposes of such program, would need to have the capability and capacity to supply products determined or anticipated to be in shortage; and “(II) in examining the capability and capacity to supply products in shortage, the ‘qualified manufacturer’ could have a site that manufactures a drug listed under section 506E or have the capacity to produce drugs in response to a shortage within a rapid timeframe; and “(ii) shall examine whether incentives are necessary to encourage the participation of ‘qualified manufacturers’ in such a program. “(D) Consultation.— In carrying out this paragraph, the task force shall ensure consultation with the appropriate offices within the Food and Drug Administration, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Office of Regulatory Affairs, and employees within the Department of Health and Human Services with expertise regarding drug shortages. The Secretary shall engage external stakeholders and experts as appropriate. “(2) Timing.— Not later than 1 year after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the task force shall— “(A) publish the strategic plan described in paragraph (1); and “(B) submit such plan to Congress. “(b) Communication.— The Secretary shall ensure that, prior to any enforcement action or issuance of a warning letter that the Secretary determines could reasonably be anticipated to lead to a meaningful disruption in the supply in the United States of a drug described under section 506C(a), there is communication with the appropriate office of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or exacerbate, a shortage of the drug. “(c) Action.— If the Secretary determines, after the communication described in subsection (b), that an enforcement action or a warning letter could reasonably cause or exacerbate a shortage of a drug described under section 506C(a), then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation involved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to humans. “(d) Reporting by Other Entities.— The Secretary shall identify or establish a mechanism by which health care providers and other third-party organizations may report to the Secretary evidence of a drug shortage. “(e) Review and Construction.— No determination, finding, action, or omission of the Secretary under this section shall— “(1) be subject to judicial review; or “(2) be construed to establish a defense to an enforcement action by the Secretary. “(f) Sunset.— Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act.” .

2. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3616(a)(2) · 136 Stat. 4459

   Amended · 21 U.S.C. § 356d(f)

   Pub. L. 117–328, § 3616(a)(2), amended subsec. (f) generally. Prior to amendment, text read as follows: “Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after July 9, 2012.”

   Source evidence

   Code amendment note
   Subsec. (f). Pub. L. 117–328, § 3616(a)(2), amended subsec. (f) generally. Prior to amendment, text read as follows: “Subsections (a), (b), (c), and (e) shall cease to be effective on the date that is 5 years after July 9, 2012.”

   Enacted provision · exact public law section
   (2) by amending subsection (f) to read as follows: “(f) Temporary Sunset.— Subsection (a) shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act. Time period. Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act and ending on the date of enactment of the Food and Drug Omnibus Reform Act of 2022. Effective date. Subsections (b), (c), and (e) shall be in effect beginning on the date of enactment of the Food and Drug Omnibus Reform Act of 2022.” .

3. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3616(a)(1) · 136 Stat. 4459

   Added · 21 U.S.C. § 356d(g)

   Pub. L. 117–328, § 3616(a)(1), added subsec. (g)

   Source evidence

   Code amendment note
   Subsec. (g). Pub. L. 117–328, § 3616(a)(1), added subsec. (g).

   Enacted provision · exact public law section
   (1) by adding at the end the following: “(g) Coordination.— The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program regarding— “(1) the reviews of reports shared pursuant to section 704(b)(2); and “(2) any feedback or corrective or preventive actions in response to such reports.” ; and

3 of 3 references resolved to an enrolled provision