; brand and generic drug manufacturers; standard development organizations; wholesalers and distributors; payers; health care providers; pharmacists; pharmacies; manufacturers; poison centers; and representatives of the National Institute on Drug Abuse, the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Drug Enforcement Agency, the Consumer Product Safety Commission, individuals who specialize in treating addiction, and patient and caregiver groups. . (b) Prohibited acts Section 501 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 ) is amended by inserting after paragraph (j) the following: (k) If it is a drug approved under a covered application (as defined in section 505–2(e)), the holder of which does not meet the requirements of paragraphs (1) and (2) of subsection (b) of such section. . (c) Required content of an abbreviated new drug application Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(2)(A) ) is amended— (1) in clause (vii)(IV), by striking and at the end; (2) in clause (viii), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (ix) if the drug is or contains an opioid for which a listing in schedule II or III (on a temporary or permanent basis) is in effect under section 202 of the Controlled Substances Act, information to show that the applicant has proposed technologies, controls, or measures related to the packaging or disposal of the drug that provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505–2, if applicable. . (d) Grounds for refusing To approve an abbreviated new drug application Section 505(j)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(4) ), is amended— (1) in subparagraph (J), by striking or at the end; (2) in subparagraph (K), by striking the period at the end and inserting ; or