For the twenty-third year, during the early summer months, the International Academy of Compounding Pharmacists (IACP) held its Compounders on Capitol Hill meeting in Washington, D.C. from June 10-13, 2017. Keith S. Hasson, founder of the Hasson Law Group, attended the meeting as the guest of two of his long-time clients in the compounding industry. During and after the meeting, Keith has reviewed and discussed with IACP members two dramatic legislative changes that deserve the support of compounders throughout the Nation. The legislation was introduced, and all compounding pharmacists in Georgia and around the country need to review it and, hopefully, get busy supporting it. (more…)
Keith Hasson authored an article published by Law360 on March 28, 2017, discussing the ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration (FDA) inspection methods and the proposed rule adding new bulk substances that can be used in compounding.
The tragic and painful drama of The New England Compounding Center (NECC) came to a dramatic point last week with the conclusion of the criminal trial of its co-founder and chief executive officer. This was the latest chapter in a scandal that has, unfortunately, thrown a negative light on all compounding pharmacies. As the Boston Globe observed, the trial and the scandal “opened a window onto the little-known compounding industry.”
In 2012, fungal meningitis and other infections in twenty states were traced by the CDC to contaminated steroids, used principally to treat back pain, that were produced by NECC. This national outbreak was caused by fungal contamination of three batches of preservation-free methylprednisolone acetate (MPA). Vials of the steroid were shipped to pain management clinics, primarily in Tennessee, Indiana, and Michigan. The fungus-contaminated drugs killed 64 people in nine states. In addition to the 64 deaths, 753 people became seriously ill.
As the federal trial of the New England Compounding Center (NECC) continues, Keith Hasson was quoted in Pain Medicine News on Feb. 16, 2017, discussing the ongoing crackdown compounding pharmacies face from the Drug Quality and Security Act.
A recent report from the FDA stated that the administration has issued more than 130 warning letters to compounders over federal violations and overseen about 100 recalls since the law went into effect in 2012. Hasson notes that the report “reads like a document trying to justify (the FDA’s) efforts in the compounding pharmacy space, and they make a pretty good case.” For the full article, please click here.
Some pharmacists are expressing frustration over the time it is taking for the FDA to finalize its guidance on various areas involving compounded drugs, according to a November 2016 report from the U.S. Government Accountability Office.
Nearly a quarter of stakeholder organizations said it is difficult for pharmacies to move forward without final guidance from the FDA about which drugs it considers difficult to compound. Adding drugs to a bulk drug list exempts them from stringent provisions of the Federal Food, Drug and Cosmetic Act and means that pharmacies can use those drugs as active ingredients in compounded medications. (more…)
The FDA has provided a new look at its efforts to ensure the safety of compounded drugs over the past three years in a report released earlier this month. This progress report comes days after the beginning of a criminal trial involving a fatal fungus meningitis outbreak in 2012 that occurred due to drugs being compounded with contaminated and expired ingredients. The compounded drugs were blamed for more than 60 deaths and 750 cases of infection, affecting patients in 20 states, according to the FDA.
Since that event, the safety of compounded drugs has been in the spotlight. In 2013, Congress enacted the Drug Quality and Security Act, which stepped up oversight of compounding pharmacies. The FDA says it has devoted significant agency resources to implementing and enforcing the compounding-related regulations.
In an article published by Pharmacy Practice News, Keith Hasson, managing partner of Hasson Law Group, notes that the report “reads like a document trying to justify [the FDA’s] efforts in the compounding pharmacy space, and they make a pretty good case.” (more…)