Sec. 2. Risk assessments and risk mitigation plans for drugs
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/bill/116/hr/6660/ih/section-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506C–1 of such Act ( 21 U.S.C. 356c–1 ) the following new section: In this section, the term covered drug — means a drug that— is described in section 506C(a); or is included, or was included at any point during the preceding 5 years, in the drug shortage list in effect under section 506E; and includes any such drug that is not required to be approved pursuant to an application under subsection
(b)or
(j)of section 505 of this Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act to be lawfully marketed. The manufacturer of a covered drug shall— conduct a risk assessment that identifies and evaluates risks to the supply of the drug, including vulnerabilities that would likely lead to a meaningful disruption in the supply of the drug in the United States; develop and maintain a risk mitigation plan to ensure the supply of the drug during such a shortage; and implement such plan during such a shortage. The Secretary shall— maintain the confidentiality of any risk assessment, and any risk mitigation plan, under this section; and limit the use by the Secretary of information in such an assessment or plan to preventing, mitigating, or responding to a drug shortage. The Secretary shall publish guidance on— how manufacturers should work with their supply chain partners in developing the required risk assessments and risk mitigation plans; the elements of a risk mitigation plan under this section; and the form and manner of developing and maintaining such plan. A risk mitigation plan under this section shall be subject to inspection and copying by the Secretary under section 704. The Secretary may conduct an expedited inspection or review as described in section 506C(g) for the purpose of facilitating the implementation of a risk management plan developed pursuant to this section. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: The failure to conduct a risk assessment, or to develop, maintain, and implement a risk mitigation plan, in accordance with section 506C–2. . The amendments made by this section apply beginning on the date that is 24 months after the date of enactment of this Act, except that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall have discretion to allow persons subject to such amendments additional time to comply with such amendments as the Secretary determines necessary.
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U.S. Code
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- 21 USC 356c–1
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