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Out of Shortage, Into Controversy: The Fight Over GLP-1 Compounding

Pharmacy Times

Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

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