How HR 5687 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill introduces new requirements for packaging and disposal methods for certain drugs to mitigate the risk of misuse and abuse.

• 21 U.S.C. 355

  SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.

  This section establishes a new requirement for safety-enhancing packaging and disposal features for certain drugs.

• 21 U.S.C. 351

  (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.

  This addition allows drugs that fail to meet new packaging and disposal requirements to be classified as adulterated.

• 21 U.S.C. 355(j)(2)(A)

  by striking the period at the end and inserting ``; and``; → ``(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.``

  This change requires additional information regarding opioid packaging and disposal measures in abbreviated new drug applications.

• 21 U.S.C. 355(j)(4)

  by striking the period at the end and inserting ``; or``; → ``(L) if the drug is a drug described in paragraph (2)(A)(ix) and the applicant has not proposed technologies, controls, or measures related to the packaging or disposal of such drug that the Secretary determines provide protections comparable to those provided by the technologies, controls, or measures required for the applicable listed drug under section 505-2.``

  This change expands the grounds for refusing to approve an abbreviated new drug application if it does not meet packaging and disposal requirements for opioids.