Food and Drug Administration (FDA) has issued five draft documents related to drug compounding and repackaging requirements under the Drug Quality and Security Act (DQSA). The draft documents are applicable…
More ›Legislation proposed by Senator David Vitter (R-LA) would revise Section 503A of the FD&C Act to exempt drug products where the pharmacy’s product is “compounded and distributed to a practitioner…
More ›…by the pharmacy must be provided to the Board, as well as notification of any disciplinary action taken by another state or suspension of any accreditation held by the pharmacy….
More ›Our business (or an affiliated business) has an FDA Warning Letter regarding compounding. Are we eligible to apply for Healthcare Merchant Accreditation? If you or your affiliate (as that term…
More ›When should my facility submit the application for our facility to be inspected based on the proposed, revised compounding USP Chapters? VPP applications received June 1– September 31, 2023: USP…
More ›…Information Design Inc Mahantech Corp Health Information Design Inc Health Information Design Inc Health Information Design Inc State PMP South Carolina PMP West Virginia PMP North Dakota PMP Kansas PMP…
More ›…of Sterile Preparations form. In addition, TSBP recognizes the VPP Sterile Compounding Inspection Form as meeting this requirement. Contact us for more information by emailing inspections@nabp.pharmacy or calling 847/391-4539 and…
More ›…registered with FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities. The guidance document describes the agency’s recommendations for…
More ›…pharmacy, and state boards of health, asking state regulators to consider strategies that might encourage non-resident compounding pharmacies that ship compounded sterile drugs into their states to register as outsourcing…
More ›FDA and Centers for Disease Control and Prevention (CDC) report that samples of two additional recalled New England Compounding Center (NECC) products, preservative-free injectable betamethasone and cardioplegia solution, have tested…
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