1. Short title This Act may be cited as the Limit Ongoing Shortages and Stabilize Supply Act of 2020 or the LOSS Act of 202 0 . 2. Risk assessments and risk mitigation plans for drugs (a) In general 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: 506C–2. Risk assessments and risk mitigation plans for drugs (a) Covered drug defined In this section, the term covered drug — (1) means a drug that— (A) is described in section 506C(a); or (B) is included, or was included at any point during the preceding 5 years, in the drug shortage list in effect under section 506E; and (2) 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. (b) Requirement The manufacturer of a covered drug shall— (1) 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; (2) develop and maintain a risk mitigation plan to ensure the supply of the drug during such a shortage; and (3) implement such plan during such a shortage. (c) Confidentiality The Secretary shall— (1) maintain the confidentiality of any risk assessment, and any risk mitigation plan, under this section; and (2) limit the use by the Secretary of information in such an assessment or plan to preventing, mitigating, or responding to a drug shortage. (d) Guidance The Secretary shall publish guidance on— (1) how manufacturers should work with their supply chain partners in developing the required risk assessments and risk mitigation plans; (2) the elements of a risk mitigation plan under this section