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.
January 16th 2024
Although robotics can be instrumental in assuring sterility and reducing the overall number of potential hazardous drug exposure events, certain tasks require vigilant oversight.
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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FDA Proposes the Removal and Addition of Substances to Its 503A Bulks List
January 2nd 2017The FDA has created a new proposed rule that adds 6 bulk drug substances to an existing list of substances that can be used in compounding. It has also proposed the removal of 4 other bulk drug substances from the list.
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