; and (3) the form and manner of developing and maintaining such plan. (e) Inspection A risk mitigation plan under this section shall be subject to inspection and copying by the Secretary under section 704. (f) Expedited inspections and reviews 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. . (b) Prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (fff) The failure to conduct a risk assessment, or to develop, maintain, and implement a risk mitigation plan, in accordance with section 506C–2. . (c) Applicability 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. 3. Discontinuance or interruption in production (a) Active pharmaceutical ingredients (1) Active pharmaceutical ingredients Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended by adding at the end the following: (j) Applicability with respect to active pharmaceutical ingredients This section shall apply with respect to an active pharmaceutical ingredient in a drug described in subsection (a) in the same manner and to the same extent as this section applies with respect to a drug described in subsection (a), except that subsection (i) shall not apply with respect to active pharmaceutical ingredients. . (2) Guidance (A) Issuance Not later than 24 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance on implementing the amendment made by paragraph