The Pharmacy Times® 503B Compounding Pharmacy Resource Center is a comprehensive resource for clinical news and expert insights on issues related to compounding pharmacies and drug safety.
November 1st 2024
Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.
The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, announced that it is launching a national advocacy initiative related to compounding that will be focused on pending federal and state legislation and regulation through agencies such as the FDA.
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