Reed Smith Client Alerts

Key takeaways

  • HHS and FDA have released regulatory agendas for 2024 and beyond
  • Priorities include rulemaking and guidance documents impacting the pharmacy industry
  • Pharmacies and other industry stakeholders should stay apprised of developments and understand how regulatory activities could impact their businesses

On February 9, 2024, the Department of Health and Human Services (HHS) published its semiannual regulatory agenda identifying the regulatory activities the Department expects to undertake in the foreseeable future. Among the identified activities, the Department notes the Food and Drug Administration’s (FDA) plans to propose rules on the following topics that could impact pharmacies nationwide:

  • Additions to 503A and 503B Bulks Lists. FDA intends to identify and consider additional bulk drug substances to propose placing on the 503A and 503B Bulks Lists and certain bulk drug substances not to include on the 503A and 503B Bulks Lists.
  • Memorandum of understanding governing the distribution of compounded human drug products. FDA intends to propose rulemaking regarding the distribution of compounded human drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a state board of pharmacy or other appropriate state agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such state and distributed outside such state and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will, if finalized, include provisions regarding the statutory 5 percent limit on the distribution of compounded human drug products out of the state in which they are compounded in states that do not sign the standard MOU. The rule will also, if finalized, address communication with state boards of pharmacy.