Section
Regulation
Rules, guidance and notices that set what may be compounded, from which substances, and by whom. Sourced from the Federal Register.
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FDA asks consumer organisations to nominate advisory committee representatives
The agency requested that consumer organisations interested in selecting consumer representatives notify it in writing, and asked for nominations to fill current and expected vacancies.
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Guidance sets temporary compounding policies for neonatal starter parenteral nutrition
The agency published the guidance for immediate implementation, citing the expected market exit of the predominant source of certain starter parenteral nutrition drug products.
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Draft guidance addresses animal drug compounding from bulk substances under CGMP
Draft guidance for industry number 256B sets out when the agency does not generally intend to act against compounding of animal drug products from bulk drug substances at federally registered facilities.
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Revised draft product-specific guidances published for industry
The notice announces further revised draft guidances carrying product-specific recommendations, among them recommendations on the design of bioequivalence studies supporting abbreviated new drug applications.
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Comment period extended on the 503B bulks list notice
The agency gave interested persons longer to respond to its 1 May proposal, acting on a request for an extension.
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FDA proposes not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list
The notice names three bulk drug substances the agency has considered and proposes to leave off the list that outsourcing facilities draw on when compounding.