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 […]
Read More ›CDC Reports Overdose Deaths Among Youth More Than Doubled From 2019 to 2021
Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report on December 16, 2022, which recorded a 109% increase in overdose deaths involving persons aged 10-19 years from July-December 2019 to July-December 2021. Over the same period, the same age group showed a 182% increase in deaths from illicitly manufactured fentanyl. […]
Read More ›ONDCP Launches New Dashboard to Track Nonfatal Opioid Overdoses
The Office of National Drug Control Policy (ONDCP) piloted a national data dashboard, called the Opioid Overdose Tracker, which tracks the rate of nonfatal opioid overdoses. The program utilizes emergency medical services (EMS) patient care reports and maps them across all 50 states, three territories (Virgin Islands, Guam, and Northern Mariana Islands), and the District […]
Read More ›PCSC Warns of ‘Scheduled’ Drug Product Recall Fraud Incidents
The information published in this column was provided by the Healthcare Distribution Alliance (HDA) Pharmaceutical Cargo Security Coalition (PCSC). HDA PCSC is warning the pharmacy industry of a recall fraud incident involving the drug product oxycodone hydrochloride. PCSC notes that the emails/faxes that are claimed to originate from a legitimate pharmaceutical distributor state the following: […]
Read More ›How Pharmacists Can Prepare for 2023 DSCSA Implementation
When Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) in 2013, it set a 10-year timeline for full implementation. November 2023 marks the end of that timeline. A significant portion of this last milestone requires the entire supply chain to become interoperable using secure and electronic means. One requirement that […]
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