21 U.S.C. § 356d — Coordination; task force and strategic

Page 287 TITLE 21—FOOD AND DRUGS § 356d (June 25, 1938, ch. 675, § 506C–1, as added Pub. L. 112–144, title X, § 1002, July 9, 2012, 126 Stat. 1102; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(F), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 117–328, div. FF, title III, § 3616(b)(1), Dec. 29, 2022, 136 Stat. 5875.) Editorial Notes AMENDMENTS 2022—Subsec. (a)(3) to (5). Pub. L. 117–328, § 3616(b)(1)(A), (B), added pars. (3) and (4) and redesig- nated former par. (3) as (5). Former pars. (4) and (5) re- designated (6) and (7), respectively. Subsec. (a)(5)(A). Pub. L. 117–328, § 3616(b)(1)(C), sub- stituted ‘‘paragraph (9)’’ for ‘‘paragraph (7)’’. Subsec. (a)(6) to (9). Pub. L. 117–328, § 3616(b)(1)(A), re- designated pars. (4) to (7) as (6) to (9), respectively. 2016—Subsec. (a). Pub. L. 114–255, in introductory pro- visions, substituted ‘‘Not later than March 31 of each calendar year,’’ for ‘‘Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter,’’ and inserted ‘‘, with respect to the preceding calendar year,’’ after ‘‘a report’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–328, div. FF, title III, § 3616(b)(2), Dec. 29, 2022, 136 Stat. 5875, provided that: ‘‘The amendments made by paragraph (1) [amending this section] shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1) on or after March 31, 2024.’’ § 356d. Coordination; task force and strategic plan (a) Task force and strategic plan (1) In general (A) Task force As soon as practicable after July 9, 2012, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary’s response to pre- venting and mitigating drug shortages. (B) Strategic plan The strategic plan described in subpara- graph (A) shall include— (i) plans for enhanced interagency and intra-agency coordination, communica- tion, and decisionmaking; (ii) plans for ensuring that drug short- ages 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 commu- nication 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 estab- lish a ‘‘qualified manufacturing partner program’’, as described in subparagraph (C). (C) Description of program In conducting the examination of a ‘‘quali- fied manufacturing partner program’’ under subparagraph (B)(v), the Secretary— (i) shall take into account that— (I) a ‘‘qualified manufacturer’’, for pur- poses of such program, would need to have the capability and capacity to sup- ply products determined or anticipated to be in shortage; and (II) in examining the capability and ca- pacity to supply products in shortage, the ‘‘qualified manufacturer’’ could have a site that manufactures a drug listed under section 356e of this title or have the capacity to produce drugs in re- sponse to a shortage within a rapid time- frame; 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 ap- propriate offices within the Food and Drug Administration, including the Office of the Commissioner, the Center for Drug Evalua- tion and Research, the Office of Regulatory Affairs, and employees within the Depart- ment of Health and Human Services with ex- pertise regarding drug shortages. The Sec- retary shall engage external stakeholders and experts as appropriate. (2) Timing Not later than 1 year after July 9, 2012, 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 let- ter that the Secretary determines could reason- ably be anticipated to lead to a meaningful dis- ruption in the supply in the United States of a drug described under section 356c(a) of this title, there is communication with the appropriate of- fice of the Food and Drug Administration with expertise regarding drug shortages regarding whether the action or letter could cause, or ex- acerbate, a shortage of the drug. (c) Action If the Secretary determines, after the commu- nication described in subsection (b), that an en- forcement action or a warning letter could rea- sonably cause or exacerbate a shortage of a drug described under section 356c(a) of this title, then the Secretary shall evaluate the risks associated with the impact of such shortage upon patients and those risks associated with the violation in- volved before taking such action or issuing such letter, unless there is imminent risk of serious adverse health consequences or death to hu- mans. (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— Page 288 TITLE 21—FOOD AND DRUGS § 356e (1) be subject to judicial review; or (2) be construed to establish a defense to an enforcement action by the Secretary. (f) Temporary sunset Subsection (a) shall cease to be effective on the date that is 5 years after July 9, 2012. Sub- sections (b), (c), and (e) shall not be in effect during the period beginning 5 years after July 9, 2012, and ending on December 29, 2022. Sub- sections (b), (c), and (e) shall be in effect begin- ning on December 29, 2022. (g) Coordination The Secretary shall ensure timely and effec- tive internal coordination and alignment among the field investigators of the Food and Drug Ad- ministration 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 374(b)(2) of this title; and (2) any feedback or corrective or preventive actions in response to such reports. (June 25, 1938, ch. 675, § 506D, as added Pub. L. 112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103; amended Pub. L. 117–328, div. FF, title III, § 3616(a), Dec. 29, 2022, 136 Stat. 5874.) Editorial Notes AMENDMENTS 2022—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.’’ Subsec. (g). Pub. L. 117–328, § 3616(a)(1), added subsec. (g). § 356e. Drug shortage list (a) Establishment The Secretary shall maintain an up-to-date list of drugs that are determined by the Sec- retary to be in shortage in the United States. (b) Contents For each drug on such list, the Secretary shall include the following information: (1) The name of the drug in shortage, includ- ing the National Drug Code number for such drug. (2) The name of each manufacturer of such drug. (3) The reason for the shortage, as deter- mined by the Secretary, selecting from the following categories: (A) Requirements related to complying with good manufacturing practices. (B) Regulatory delay. (C) Shortage of an active ingredient. (D) Shortage of an inactive ingredient component. (E) Discontinuance of the manufacture of the drug. (F) Delay in shipping of the drug. (G) Demand increase for the drug. (4) The estimated duration of the shortage as determined by the Secretary. (c) Public availability (1) In general Subject to paragraphs (2) and (3), the Sec- retary shall make the information in such list publicly available. (2) Trade secrets and confidential information Nothing in this section alters or amends sec- tion 1905 of title 18 or section 552(b)(4) of title 5. (3) Public health exception The Secretary may choose not to make in- formation collected under this section pub- licly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would ad- versely affect the public health (such as by in- creasing the possibility of hoarding or other disruption of the availability of drug products to patients). (d) Interagency notification Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the cur- rent drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services. (June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, § 3112(c), Mar. 27, 2020, 134 Stat. 362.) Editorial Notes AMENDMENTS 2020—Subsec. (d). Pub. L. 116–136 added subsec. (d). 2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of ‘‘discontinuance’’ for ‘‘discontinu- ation’’, was executed by substituting ‘‘Discontinuance’’ for ‘‘Discontinuation’’ to reflect the probable intent of Congress. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2020 AMENDMENT Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title. § 356f. Hospital repackaging of drugs in shortage (a) Definitions In this section: (1) Drug The term ‘‘drug’’ excludes any controlled substance (as such term is defined in section 802 of this title). (2) Health system The term ‘‘health system’’ means a collec- tion of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients. (3) Repackage For the purposes of this section only, the term ‘‘repackage’’, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to— (A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title; and