Archive for April 2016
FDA's Most Recent Guidance: Prescription Requirements Under Section 503A
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses: Compounding after the receipt…
Read MoreFDA's Most Recent Guidance: Hospitals and Health System Drug Compounding
Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding Prescription Requirement Under Section 503A Clarifying the definition of “Facility” under Section 503B This article will focus…
Read MoreA Texas Compounder, the FDA and the Texas Board of Pharmacy: State or Federal Oversight?
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance. The FDA found numerous safety issues during its February 2016 which prompted them to recommend…
Read More