Universities in South Carolina Initiate Program to Advance AI in Health Care
Universities and colleges in South Carolina are joining a federally funded, Clemson University-led coalition focused on advancing artificial intelligence (AI) technology in health care diagnostics and treatment. Funded by the National Science Foundation, the program is called Artificial Intelligence-Enabled Devices for the Advancement of Personalized and Transformative Health Care in South Carolina. In addition to […]
Read More ›Narcan Nasal Spray Becomes an OTC Drug
Food and Drug Administration (FDA) approved the Narcan® 4 mg naloxone hydrochloride nasal spray to be sold over-the-counter (OTC), making it the first naloxone product that will be available without a prescription. Naloxone is a life-saving medication that reverses the effects of opioid overdoses. The product will include instructions for consumers regarding how to use […]
Read More ›Importation of Xylazine Restricted Due to Increasing Public Health Concern
Food and Drug Administration (FDA) announced that it is restricting the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the United States to address growing concerns of the chemical appearing in drugs such as illicitly manufactured fentanyl, methamphetamine, and cocaine. The agency warns that individuals who inject products containing […]
Read More ›FDA Launches New Dietary Supplement Ingredient Directory
Food and Drug Administration (FDA) launched its new Dietary Supplement Ingredient Directory, which is a database that lists the ingredients used in products marketed as “dietary supplements” and FDA’s actions taken and statements made in response to those ingredients. The agency will update the directory periodically to show recent developments. FDA notes that additional feedback […]
Read More ›Guidance for Compounding Ibuprofen Oral Suspension Products Issued by FDA
Food and Drug Administration (FDA) has issued guidance and revisions regarding compounding certain ibuprofen oral suspension products to address the ongoing demand for fever- and pain-reducing medications. The latest guidance revisions provide recommendations for ibuprofen oral suspension products compounded by outsourcing facilities and supplied to state-licensed pharmacies (including those within hospitals and health systems) and […]
Read More ›New Privacy Protections for Patients With Substance Use Challenges Proposed by HHS
The United States Department of Health and Human Services (HHS) declared proposed changes to the Confidentiality of Substance Use Disorder Patient Records under 42 Code of Federal Regulations (“Part 2”). Under this proposed change, coordination of care for patients would improve, and the protection of privacy for patients facing substance use challenges would be strengthened. […]
Read More ›Final Guidance Containing Definitions Relevant to DSCSA Released by FDA
Food and Drug Administration (FDA) released the final guidance document, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, as part of the preparation for implementation of the Drug Supply Chain Security Act (DSCSA). The terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution” are clarified […]
Read More ›Proposed Rules for Permanent Telemedicine Flexibilities Announced by DEA
Drug Enforcement Administration (DEA) has proposed permanent rules for prescribing controlled medications through telemedicine, which were established during the coronavirus disease 2019 pandemic. The proposed rules address telemedicine consultations by a medical practitioner who has never conducted an in-person evaluation of a patient and that would result in the prescribing of a controlled medication. Under […]
Read More ›FDA Publishes Notice of COVID-19-Related Guidance Documents Expiring With PHE
Food and Drug Administration (FDA) published a notice that the guidance documents addressing the coronavirus disease 2019 (COVID-19) public health emergency (PHE) will no longer be effective after the PHE declaration ends on May 11, 2023. This notice will affect 72 COVID-19-related guidance documents. The agency is expected to monitor and assess the circumstances of […]
Read More ›Confused drug names: Ilaris and Ilumya
A specialty pharmacy recently reported look- and sound-alike concerns with Ilaris® (canakinumab), an interleukin-1 beta inhibitor used for Still’s disease, periodic fever syndromes, and systemic juvenile idiopathic arthritis; and Ilumya® (tildrakizumab), an interleukin-23 inhibitor used for plaque psoriasis. Product similarities increase the risk of mix-ups. Both brand names start with the letters “I-L,” and both […]
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