Resolving disputes between two parties is the basis for the American civil legal system. While litigation and trial are the most obvious methods when it comes to legal disputes, there are also other options available that can resolve the issues without going to trial. Going to trial is expensive and time consuming. Often, alternative dispute […]
The Compounding Quality Act (CQA) brought significant changes to compounding pharmacies in the United States. The changes made by the CQA include the introduction of a new category of compounders, outsourcing facilities, that compound sterile medications. An outsourcing facility compounds sterile drugs for use by healthcare providers or for use by individual patients. Below are […]
Healthcare reform has been one of the top news stories and realities of life for the past few years. The reforms of 2014 were significant and those changes will still be felt well in 2015 and beyond. We will take a look at what the healthcare reform has in store next. For sure, we know […]
Healthcare organizations often stumble across Stark Law requirements by accident, and many times, their encounter is not a pleasant one. Healthcare entities discover potential violations of Stark Law during routine compliance audits without even knowing the event occurred until it is too late. Healthcare organizations should have an understanding as to what Stark Law is, […]
Pharmacies are a part of modern life. If a physician wants a patient to take a certain medication, the patient takes a quick trip to the pharmacy to pick up the prescription. However, if the medication is not commercially available, that is where a compounding pharmacy takes over. What exactly is a compounding pharmacy? We […]
When Congress passed the HIPAA Privacy Rule in 1996, it presented challenges for healthcare organizations when working with patient information. However, these organizations have also seen benefits from HIPAA. For healthcare organizations, meeting the provisions regarding this privacy rule can be tricky and they are advised to find guidance from an experienced law firm they […]
In late 2013, the U.S. Congress passed the Compounding Quality Act (“CQA”). This Act provides for additional FDA oversight of compounding pharmacies. However, this oversight change has brought up new questions for pharmacies and how it affects their compounding operations. What Is The Compounding Quality Act? The CQA is Title I of the larger Drug […]
