In Georgia, the compounding of medications is regulated by the eight-member Georgia Board of Pharmacy, and under its rules, pharmacists may prepare compound drugs only for a valid prescription order or as part of routine prescription filling. If they start to produce large amounts of drugs without prescriptions, they are considered manufacturers. In a law […]
Two bulk substances that can treat warts and skin discoloration have been approved for use in compounded medications in a meeting of the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee. Three other ingredients were kept off the list by the eight-member committee, following the FDA’s recommendation. It also unanimously voted to classify transdermal […]
The FDA released guidance that represents the agency’s current thinking on insanitary conditions, which can be defined as “so dirty or ridden with germs as to be a danger to health.” So what conditions are potential pitfalls for compounding pharmacies?
Note: This article was published Nov. 3, 2016, in Specialty Pharmacy Times. Fraud is a leading concern of federal investigators and the compounding pharmacies they oversee. Compounded drugs are covered by Medicare’s Part D program, and they accounted for a 56 percent increase in costs over the last year, according to a June report on Medicare […]
An amendment to the Georgia Pharmacy Practice Act that went into effect July 1, 2016, authorizes the Board of Pharmacy to create rules for the permitting of outsourcing facilities and third-party logistics providers in Georgia. This change allows the state to recognize and create its own rules for outsourcing facilities under Section 503B of the […]
The FDA has put greater scrutiny on compounding pharmacies since August 2016, with inspectors making preliminary assessments on compliance for patient-specific prescriptions and other rules under Section 503A of the federal Food, Drug and Cosmetic Act. The change allows investigators to cite deviations from the current good manufacturing practices when it appears the pharmacy does […]
A change in the methods Food and Drug Administration (FDA) inspectors follow when inspecting compounding pharmacies could result in drastic regulatory outcomes. Since August 1, 2016, FDA investigators have been making preliminary assessments during inspections of non-outsourcing facilities on whether the facility is compounding human drugs in accordance with certain provision of Section 503A of […]
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The Hasson Law Group is thrilled to announce that James K. Hasson, Jr. has joined the firm. If the name is familiar, it’s because Jim is the father of the Keith Hasson, our firm’s founder. Jim has experience in advising both individuals and businesses about a wide variety of business transactions, ranging from business formation to business sales and purchases.