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.
Key Points From the 2016 NIOSH List of Antineoplastic and Hazardous Drugs in Health Care Settings
March 20th 2018In response to the numerous concerns regarding antineoplastic drugs and other medications that may threaten the health of patients and health care workers, the National Institute for Occupational Safety and Health (NIOSH) developed a list, updated biennially, of hazardous drugs.
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Authorizing Technician Activity When No Pharmacist Is Present
February 28th 2018The pharmacist-in-charge was out of town, but an order came in for a compounded chemotherapy medication that was needed the same day, so he authorized a technician to prepare it with no pharmacist present to supervise.
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Key Points to Consider From USP
January 25th 2018Each year, more than 8 million U.S. health care personnel are potentially exposed to hazardous medications. Acute and chronic health effects have been reported, including headaches, ocular problems, rashes, hair loss, adverse reproductive health, and increased cancer risk.
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New Compounding Pharmacy Policy Priorities Plan Released
January 23rd 2018Officials with the FDA have issued 2 final guidance documents to help implement the 2018 Compounding Policy Priorities Plan, which explain the agency’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
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FDA Officials Warn About Compounding Risk
October 4th 2017According to an "FDA in Brief" report, officials with the FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV).
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