FDA Issues Guidance on Adverse Event Reporting for Outsourcing Facilities
Food and Drug Administration (FDA) has published a guidance document, Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, intended for firms 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 […]
Read More ›US Compounding, Inc, Recalls All Lots of Sterile Compounded Products Due to Potential Safety Issue
US Compounding, Inc, of Conway, AR, issued a voluntary recall of all lots of sterile products aseptically compounded and packaged by the company, and that remain within expiry, because of a lack of sterility assurance. The affected sterile products were distributed nationwide to patients, providers, hospitals, and clinics between March 14, 2015, and September 9, […]
Read More ›Pharmacists Called to Take Action on Individual and Collective Levels by FIP President During 75th World Pharmacy Congress
At the opening ceremony of the 75th International Pharmaceutical Federation (FIP) World Congress of Pharmacy and Pharmaceutical Sciences, pharmacists and pharmaceutical scientists worldwide were called on by FIP President Carmen Peña to ensure the pharmacy profession remains relevant and able to respond effectively to current and future needs of the world’s communities. During her inaugural […]
Read More ›FIP Report Offers Case Studies on Interprofessional Education, Indicates Such Training Becoming More Common
Multidisciplinary education among pharmacists, future pharmacists, and other health care providers is becoming more common as the need for collaborative practice increases, indicates a new report from the International Pharmaceutical Federation (FIP) Education Initiative. Both World Health Organization and FIP have agreed that interprofessional education (IPE) is “a foundation for a collaborative, practice-ready workforce and […]
Read More ›Risk of Dose Confusion and Medication Errors With Avycaz, FDA Cautions
Confusion about the drug strength displayed on the vial and carton labels has led to some dosing errors with the intravenous antibacterial drug AvycazTM (ceftazidime and avibactam), warns FDA. The agency explains that Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (2 g/0.5 g); […]
Read More ›California Bill Requiring Pharmacists to Provide Patients With Translated Directions for Use Awaits Governor’s Signature
A bill passed by the California Legislature would require the state’s pharmacies to provide translations of prescription drug labels and medication instructions into any of five specified languages. If signed into law by Governor Jerry Brown, the bill, AB 1073, would take effect January 1, 2016, and would require translated directions “printed on the prescription […]
Read More ›Pharmacy Stakeholders Worldwide to Share Practice Information During FIP 2015 Congress, NABP to Present
Practitioners, researchers, and academics worldwide will gather to help shape modern pharmacy practice during the 75th International Pharmaceutical Federation (FIP) World Congress of Pharmacy and Pharmaceutical Sciences 2015. Held from September 29 to October 3, 2015, in Düsseldorf, Germany, the congress will focus on how to make evidence-based pharmaceutical science the driving force of modern […]
Read More ›Prescription Drug Use Levels Remain Constant in 2014, SAMHSA Reports
According to the 2014 National Survey on Drug Use and Health (NSDUH) (PDF), the number of people abusing prescription medications in the last 30 days was 6.5 million, which is similar to 2013 levels. The annual report, conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA), also found that an estimated 4.3 million […]
Read More ›Winnipeg Online Drug Outlet Advertises Unapproved Drugs to Americans
TotalCareMart, an Internet drug outlet based in Winnipeg, has been ordered to shut down by the College of Pharmacists of Manitoba and is being investigated by Health Canada. TotalCareMart, which is not licensed as a pharmacy by the College of Pharmacists of Manitoba, has been advertising drugs that are not approved by Health Canada. Print […]
Read More ›Web Search Engine to Warn About Fake Online Pharmacies
To help consumers avoid potentially unsafe online drug outlets, Bing will provide a new warning message on certain search results in Bing.com. “This warning will appear if a Bing user clicks on a pharmaceutical site that has been cited by the FDA as a fake online pharmacy engaged in illegal activity, such as offering dangerous, […]
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