Lexology February 16, 2024
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...
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