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.
FDA Issues New Guidance for Compounding Facilities
November 21st 2014Expanding upon efforts to implement the federal Drug Quality and Security Act enacted 1 year ago, the FDA today released 3 policy documents that assist companies that compound sterile drugs with registering as outsourcing facilities.
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Diplomat Specialty Pharmacy Receives Compounding Pharmacy Accreditation from PCAB
June 27th 2013Diplomat Specialty Pharmacy, the country's largest independent specialty pharmacy servicing the needs of patients and physicians nationwide, is pleased to announce the company's compounding pharmacy has been accredited by the Pharmacy Compounding Accreditation Board (PCAB).
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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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