Posts Tagged ‘FDA’
FDA Reiterates Its Concerns on Risks Associated with Kratom
The FDA announced the voluntary destruction and recall of large volumes of kratom-containing dietary supplements manufactured and distributed nationwide by Divinity Products Distribution. Divinity also agreed to stop selling all products containing kratom. The FDA is also strongly encouraging all other companies that sale products containing kratom intended for human consumption to stop manufacturing and…
Read MoreFDA’s 2018 Priorities for Drug Compounding
After the fungal meningitis outbreak of 2012 that killed 76 patients and injured hundreds more, Congress passed the Drug Quality and Security Act (DQSA), which, in part, tried to bring more compounding pharmacies, traditionally overseen by state boards of pharmacy, under FDA oversight. The DQSA created a new entity, called ‘outsourcing facilities,’ that could register…
Read MoreFDA Revises Labeling to Limit Pediatric Use of Opioid Cough and Cold Medicines
Today, the FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old. Once the labeling changes are made, these products will not be indicated to treat cough in any pediatric population and will be…
Read MoreFDA'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On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance).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Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding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 MoreVeterinary Compounding: Recent State Legislation Updates
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA. While the exact definition of compounding may vary…
Read MoreFDA Warning Letters Sent to California and Kentucky Compounders
The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility. Ionia Pharmacy, based in Tustin, California, and Spoonamore Drug Co., located in Louisville, Kentucky, were both issued warning letters for deficiencies in: Producing sterile drug products and putting patients at risk, Not receiving…
Read MoreFDA Delays Track-and-Trace Enforcement Once Again
The Food and Drug Administration (FDA) has delayed its enforcement of the product tracing requirements under the Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA). The DSCSA’s track-and-trace requirements took effect in July 2015, but the FDA stated it would not enforce the product tracing requirements until November 1,…
Read MoreLouisiana Board of Pharmacy Addresses the Compounding of Veterinarian Only Drugs for Office Use
Earlier this year, the Louisiana Board of Pharmacy (Louisiana Board) exercised the emergency provision of the Louisiana Administrative Procedure Act (R.S. 49:9.53.B), to amend its rules governing the compounding of drugs by pharmacies and restored the capability for pharmacies to compound drugs intended for the administration by veterinarians without the necessity of a patient-specific prescription.…
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