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During an inspection of Qualgen’s facility in Edmond, Oklahoma, FDA investigators observed "insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced," said the agency…The FDA recommended the company cease sterile operations until it fixed the problems, but Qualgen agreed only to voluntarily recall 67 lots of drugs. The recalled products were compounded before September 1, 2015 and have not yet expired…The Food and Drug Administration said it is not aware of any adverse events associated with Qualgen’s products…

• Walgreens’ Markes-Wilson: Extraordinary care for all
• CVS pharmacists show commitment to diversity
• Rite Aid’s Afilaka goes ‘above and beyond’
• Excelling in diabetes management, care
• Sam’s Club’s Cavan merges passion for people, pharmacy
• H-E-B’s Lehew, Stehling ‘do whatever it takes’
• Supporting communities through the pharmacy
• ‘Best Practice’ winners set mark for innovation
• Filling local health needs with compounding, infusion
• Topeka Pharmacy is community’s service center

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter,…demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances…. the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine…the guidance attempts to create new regulatory authority without legislation to support that effort.

Doug Long, vice president of industry relations at IMS Health, talks about how the movement toward value-based care in the US health system affects community pharmacy.

Hortense Jones of Durham...2015 Pharmacy Technician of the Year…Jones works at Durham’s Lincoln Community Health Center as the pharmacy technician supervisor, where she oversees a team of 11 pharmacy technicians…"I am truly humbled by this honor, but this is about our pharmacy team more than me," Jones said. "My leadership philosophy is to find the strengths of each employee and build an essential role for them on the team that matches their assets. As a result, they become fully engaged in advancing patient safety."

Drug distributor AmerisourceBergen Corp agreed to buy PharMEDium Healthcare Holdings Inc for $2.58 billion…expanding its business of supplying compounded drugs to hospitals…"PharMEDium brings ABC a complementary service line that is undergoing a growth renaissance as hospitals more aggressively outsource compounded sterile needs in wake of new government regulations,"…

Texas prison officials are helping their counterparts in Virginia prepare for a scheduled execution next week by providing the state with pentobarbital, a lethal drug that corrections agencies nationwide have had difficulty obtaining…Virginia prison officials also confirmed the trade…Texas and Oklahoma are among a handful of states with laws — being challenged by death penalty opponents — that allow prison officials not to disclose where they get execution drugs…Death Penalty Information Center, an anti-death penalty organization, said the drug exchange raised concerns about government transparency.

Nick Gentile, Director of State Grassroots Advocacy and Political Action for ASHP, discusses how compounding laws vary from state to state.

…the 2012 fungal meningitis outbreak connected to the New England Compounding Center…brought to light that standards for safe compounding do exist, but their enforcement may be inconsistent. So…<797> was revised having patient safety in mind, by making the standards for compounding sterile preparations as clear as possible to practitioners… Expert Panel was charged with taking a fresh look at the chapter from beginning to end and making recommendations for improved clarity and responding to stakeholder input…They have…helped tailor its language to make it clearer to users and regulators… As a user of <797>, I encourage you to get involved in USP’s the standard-setting process and comment on the revised chapter, which was pre-posted for public comment on September 25, 2015.

In an extensive interview with Bloomberg BNA, IACP's (International Academy of Compounding Pharmacists)David G. Miller, RPh, Executive Vice President & CEO, discusses concerns over the Drug Quality & Security Act (DQSA), emphasizing the need for clarification over which regulatory authority is responsible for the oversight of compounding pharmacy.